hydrochlorothiazide and Obesity studies

Hydrochlorothiazide: A thiazide diuretic often considered the prototypical member of this class. It reduces the reabsorption of electrolytes from the renal tubules. This results in increased excretion of water and electrolytes, including sodium, potassium, chloride, and magnesium. It is used in the treatment of several disorders including edema, hypertension, diabetes insipidus, and hypoparathyroidism.
hydrochlorothiazide : A benzothiadiazine that is 3,4-dihydro-2H-1,2,4-benzothiadiazine 1,1-dioxide substituted by a chloro group at position 6 and a sulfonamide at 7. It is diuretic used for the treatment of hypertension and congestive heart failure.

Obesity: A status with BODY WEIGHT that is grossly above the recommended standards, usually due to accumulation of excess FATS in the body. The standards may vary with age, sex, genetic or cultural background. In the BODY MASS INDEX, a BMI greater than 30.0 kg/m2 is considered obese, and a BMI greater than 40.0 kg/m2 is considered morbidly obese (MORBID OBESITY).

Research Excerpts

Excerpt	Relevance	Reference
"This prespecified subgroup analysis of a phase III study examined the effect of adding hydrochlorothiazide (HCTZ) to olmesartan (OLM)/amlodipine (AML) in patients with moderate to severe hypertension stratified by age, sex, body mass index, and hypertension severity."	9.19	Efficacy and tolerability of triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide: a subgroup analysis of patients stratified by hypertension severity, age, sex, and obesity. ( Ammentorp, B; de la Sierra, A; Kreutz, R; Laeis, P, 2014)
"Aliskiren-based therapy provided superior BP reductions to HCTZ-based therapy with good tolerability in obese patients with hypertension."	9.14	Aliskiren-based therapy lowers blood pressure more effectively than hydrochlorothiazide-based therapy in obese patients with hypertension: sub-analysis of a 52-week, randomized, double-blind trial. ( Bush, C; Gorostidi, M; Guerediaga, J; Keefe, DL; Philipp, T; Schmieder, RE, 2009)
"To compare the effect of delapril/manidipine vs olmesartan/hydrochlorothiazide (HCTZ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients."	9.13	Effect of delapril/manidipine vs olmesartan/ hydrochlorothiazide combination on insulin sensitivity and fibrinogen in obese hypertensive patients. ( Corradi, L; Derosa, G; Fogari, R; Lazzari, P; Mugellini, A; Preti, P; Zoppi, A, 2008)
"The objective of this study was to evaluate the effects of losartan +/- hydrochlorothiazide (HCTZ) versus placebo in obese patients with systolic and diastolic hypertension."	9.13	A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. ( Abate, N; Chen, E; Creager, MA; Galet, V; Jia, G; Julius, S; Lerman, A; Lyle, PA; Oparil, S; Pool, J; Tershakovec, AM, 2008)
" Treatment-emergent adverse event rates were similar between treatment groups regardless of the presence of diabetes or body mass index (BMI) status."	6.76	A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review. ( Neutel, JM, 2011)
"Sibutramine treatment resulted in a significantly greater decrease in body weight, body mass index, and waist circumference and a significant increase in diastolic blood pressure during 24-hour blood pressure monitoring compared with placebo treatment."	6.73	Optimal treatment of obesity-related hypertension: the Hypertension-Obesity-Sibutramine (HOS) study. ( Grimm, E; Herrmann, D; Kintscher, U; Scholze, J; Unger, T, 2007)
"Insulin sensitivity was expressed as insulin resistance index (IRI), calculated as the ratio of the area under the curve (AUC) for glucose to that for insulin."	6.71	Comparative effects of candesartan and hydrochlorothiazide on blood pressure, insulin sensitivity, and sympathetic drive in obese hypertensive individuals: results of the CROSS study. ( Bombelli, M; Dell'Oro, R; Facchini, A; Grassi, G; Mancia, G; Scopelliti, F; Seravalle, G; Trevano, FQ, 2003)
" Significant dose-response differences were observed between treatments."	6.68	Lisinopril versus hydrochlorothiazide in obese hypertensive patients: a multicenter placebo-controlled trial. Treatment in Obese Patients With Hypertension (TROPHY) Study Group. ( Anzalone, DA; Falkner, B; Hutchinson, HG; Reisin, E; Tuck, ML; Weir, MR, 1997)
"This prespecified subgroup analysis of a phase III study examined the effect of adding hydrochlorothiazide (HCTZ) to olmesartan (OLM)/amlodipine (AML) in patients with moderate to severe hypertension stratified by age, sex, body mass index, and hypertension severity."	5.19	Efficacy and tolerability of triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide: a subgroup analysis of patients stratified by hypertension severity, age, sex, and obesity. ( Ammentorp, B; de la Sierra, A; Kreutz, R; Laeis, P, 2014)
"Aliskiren-based therapy provided superior BP reductions to HCTZ-based therapy with good tolerability in obese patients with hypertension."	5.14	Aliskiren-based therapy lowers blood pressure more effectively than hydrochlorothiazide-based therapy in obese patients with hypertension: sub-analysis of a 52-week, randomized, double-blind trial. ( Bush, C; Gorostidi, M; Guerediaga, J; Keefe, DL; Philipp, T; Schmieder, RE, 2009)
"This post hoc analysis of a 7-week, randomized, double-blind trial evaluated the efficacy and safety of initial irbesartan/hydrochlorothiazide treatment in 468 patients with severe, uncontrolled, hypertension (diastolic blood pressure [DBP] > or =100 mm Hg) at high cardiovascular risk."	5.14	Efficacy and safety of irbesartan/HCTZ in severe hypertension according to cardiometabolic factors. ( Franklin, SS; Neutel, JM, 2010)
"To compare the effect of delapril/manidipine vs olmesartan/hydrochlorothiazide (HCTZ) combination on insulin sensitivity and plasma fibrinogen in obese hypertensive patients."	5.13	Effect of delapril/manidipine vs olmesartan/ hydrochlorothiazide combination on insulin sensitivity and fibrinogen in obese hypertensive patients. ( Corradi, L; Derosa, G; Fogari, R; Lazzari, P; Mugellini, A; Preti, P; Zoppi, A, 2008)
"The objective of this study was to evaluate the effects of losartan +/- hydrochlorothiazide (HCTZ) versus placebo in obese patients with systolic and diastolic hypertension."	5.13	A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. ( Abate, N; Chen, E; Creager, MA; Galet, V; Jia, G; Julius, S; Lerman, A; Lyle, PA; Oparil, S; Pool, J; Tershakovec, AM, 2008)
"A post hoc pooled analysis of 2 multicenter, randomized, double-blind, active-controlled force-titration studies assessed the antihypertensive efficacy and tolerability of 7 to 8 weeks' once-daily fixed-dose irbesartan/hydrochlorothiazide (HCTZ) 300/25 mg in 796 stage 1 or 2 hypertensive patients according to age (65 years or older or younger than 65) (n=121 or 675) and presence or absence of obesity (n=378 or 414), type 2 diabetes (n=99 or 697), and high World Health Organization-defined cardiovascular risk (n=593 or 202)."	5.12	The efficacy and safety of initial use of irbesartan/hydrochlorothiazide fixed-dose combination in hypertensive patients with and without high cardiovascular risk. ( Bhaumik, A; De Obaldia, ME; Lapuerta, P; Neutel, JM; Weir, MR, 2007)
"The primary objective of this study was to determine whether combination therapy with valsartan 160 mg plus hydrochlorothiazide (HCTZ) 25 mg OD would be more effective than monotherapy with amlodipine 10 mg OD in reducing systolic blood pressure (SBP) in patients with moderate (stage II) hypertension and > or =1 other cardiovascular risk factor or concomitant condition."	5.11	Efficacy and tolerability of combination therapy with valsartan plus hydrochlorothiazide compared with amlodipine monotherapy in hypertensive patients with other cardiovascular risk factors: the VAST study. ( Bönner, G; Heintz, D; Kandra, A; Khder, Y; Malacco, E; Ruilope, LM, 2005)
" Since these metabolic defects are accentuated by obesity, we thought it important to compare the effects of 3 months' treatment with either lisinopril (20 mg/day) or low dose hydrochlorothiazide (12."	5.08	Comparison of the hemodynamic and metabolic effects of low-dose hydrochlorothiazide and lisinopril treatment in obese patients with high blood pressure. ( Chen, YD; Clinkingbeard, C; Foote, J; Hollenbeck, CB; Jeppesen, J; Maheux, P; Pei, D; Reaven, GM, 1995)
"During a 12-week, multicenter study to evaluate the efficacy and safety of lisinopril and hydrochlorothiazide (HCTZ) for the treatment of obesity-related hypertension, ambulatory blood pressure (ABP) monitoring was performed both at baseline and at study completion in 124 patients."	5.08	Nocturnal reduction of blood pressure and the antihypertensive response to a diuretic or angiotensin converting enzyme inhibitor in obese hypertensive patients. TROPHY Study Group. ( Falkner, B; Hutchinson, HG; Reisin, E; Sha, L; Tuck, ML; Weir, MR, 1998)
"Purpose - to improve antihypertensive therapy on the basis of studying the antioxidant properties of an angiotensin-converting enzyme (ACE) inhibitor (fosinopril sodium) and a diuretic (hydrochlorothiazide), their impact on endothelial dysfunction and pro-inflammatory cytokines activity in hypertensive patients with overweight and obesity."	3.85	PATHOGENETIC ADVANCES OF FOSINOPRIL SODIUM WITH HYDROCHLOROTHIAZIDE IN OBESE HYPERTENSIVE PATIENTS. ( Ashcheulova, T; Demydenko, G; Gerasimchuk, N; Kochubiei, O; Rezunenko, Y, 2017)
"Experiments were carried out to investigate whether diuretics (hydrochlorothiazide + furosemide) impact on the effects of a sodium-dependent glucose cotransporter 2 (SGLT2) inhibitor on glucose metabolism and blood pressure (BP) in metabolic syndrome SHR/NDmcr-cp(+/+) rats (SHRcp)."	3.83	Effects of diuretics on sodium-dependent glucose cotransporter 2 inhibitor-induced changes in blood pressure in obese rats suffering from the metabolic syndrome. ( Fujisawa, Y; Hitomi, H; Kittikulsuth, W; Nakano, D; Nishiyama, A; Rafiq, K; Rahman, A; Sohara, E; Sufiun, A; Uchida, S, 2016)
"We compared the effects of long-term treatment with the angiotensin-converting enzyme inhibitor perindopril and triple therapy (hydrochlorothiazide, reserpine, and hydralazine) on the metabolic and renal features in the SHR/N-corpulent (cp) rat, a genetic model of non-insulin-dependent diabetes mellitus and hypertension."	3.69	Perindopril ameliorates glomerular and renal tubulointerstitial injury in the SHR/N-corpulent rat. ( Abraham, AA; Michaelis, OE; Scalbert, E; Striffler, JS; Thibault, N; Velasquez, MT, 1997)
"Hydrochlorothiazide, a drug which is often initially prescribed for mild to moderate hypertension, failed to lower blood pressures in 9 of 43 patients but concomitantly elevated plasma norepinephrine (NE) levels in all patients with hypertension."	3.66	Fenfluramine potentiation of antihypertensive effects of thiazides. ( Coleman, MD; Kopin, IJ; Lake, CR; Ziegler, MG, 1980)
" Treatment-emergent adverse event rates were similar between treatment groups regardless of the presence of diabetes or body mass index (BMI) status."	2.76	A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review. ( Neutel, JM, 2011)
"Sibutramine treatment resulted in a significantly greater decrease in body weight, body mass index, and waist circumference and a significant increase in diastolic blood pressure during 24-hour blood pressure monitoring compared with placebo treatment."	2.73	Optimal treatment of obesity-related hypertension: the Hypertension-Obesity-Sibutramine (HOS) study. ( Grimm, E; Herrmann, D; Kintscher, U; Scholze, J; Unger, T, 2007)
" The primary endpoint was change from baseline in mean ambulatory systolic and diastolic blood pressure (SBP; DBP) during the last 6 hours of the 24-hour dosing interval."	2.73	Telmisartan/hydrochlorothiazide versus valsartan/hydrochlorothiazide in obese hypertensive patients with type 2 diabetes: the SMOOTH study. ( Davidson, J; Koval, S; Lacourcière, Y; Sharma, AM, 2007)
"Insulin sensitivity was expressed as insulin resistance index (IRI), calculated as the ratio of the area under the curve (AUC) for glucose to that for insulin."	2.71	Comparative effects of candesartan and hydrochlorothiazide on blood pressure, insulin sensitivity, and sympathetic drive in obese hypertensive individuals: results of the CROSS study. ( Bombelli, M; Dell'Oro, R; Facchini, A; Grassi, G; Mancia, G; Scopelliti, F; Seravalle, G; Trevano, FQ, 2003)
"Patients with high blood pressure are often overweight or even obese."	2.71	[Arterial hypertension in obese patients. Rationale for a prospective medical care study in the family doctor's practice]. ( Bramlage, P; Kirch, W; Sharma, AM, 2004)
" Significant dose-response differences were observed between treatments."	2.68	Lisinopril versus hydrochlorothiazide in obese hypertensive patients: a multicenter placebo-controlled trial. Treatment in Obese Patients With Hypertension (TROPHY) Study Group. ( Anzalone, DA; Falkner, B; Hutchinson, HG; Reisin, E; Tuck, ML; Weir, MR, 1997)
" All groups had mean diastolic pressure controlled at or below the 90 mmHg criterion during the period of constant methyldopa dosage for those patients who required Step 2 therapy."	2.65	Indapamide in the stepped-care treatment of obese hypertensive patients. ( Godfrey, JC; Neiss, ES; Noble, RE; Vukovich, RA; Webb, EL; Zisblatt, M, 1983)
"Insulin resistance is associated with a number of risk factors for atherosclerosis, including glucose intolerance, hypertension, and dyslipidemia."	2.38	Insulin resistance. An often unrecognized problem accompanying chronic medical disorders. ( Bell, DS, 1993)
"Chlorthalidone, 12."	1.39	Obesity and hypertension: It's about more than the numbers. ( Ferdinand, KC, 2013)
"Obesity is a risk factor for stroke, but the determinants of increased stroke risk in obesity are unknown."	1.36	Preventing increased blood pressure in the obese Zucker rat improves severity of stroke. ( Mintz, JD; Osmond, JM; Stepp, DW, 2010)
"The biguanides were a therapeutic enrichment particularly in the treatment of adipose elderly diabetics with obligatory diet."	1.26	[Indications and results of an additional differentiated pharmacotherapy of obesity]. ( Kucher, E, 1978)

Research

Studies (58)

Authors

Clinical Trials (9)

Trial Overview

Trial Outcomes

Change From Baseline in Postprandial Glucose

Timeframe	Studies, this research(%)	All Research%
pre-1990	19 (32.76)	18.7374
1990's	8 (13.79)	18.2507
2000's	13 (22.41)	29.6817
2010's	18 (31.03)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Ashcheulova, T	1
Gerasimchuk, N	1
Rezunenko, Y	1
Demydenko, G	1
Kochubiei, O	1
Ferdinand, KC	1
Roth, EM	1
Oparil, S	2
Melino, M	1
Lee, J	1
Fernandez, V	1
Heyrman, R	1
Kreutz, R	1
Ammentorp, B	1
Laeis, P	1
de la Sierra, A	1
Davies, MR	1
Gleich, K	1
Katerelos, M	1
Lee, M	1
Mount, PF	1
Power, DA	1
Rahman, A	1
Kittikulsuth, W	1
Fujisawa, Y	1
Sufiun, A	1
Rafiq, K	1
Hitomi, H	1
Nakano, D	1
Sohara, E	1
Uchida, S	1
Nishiyama, A	1
Schmieder, RE	1
Philipp, T	1
Guerediaga, J	1
Gorostidi, M	1
Bush, C	1
Keefe, DL	2
Osmond, JM	1
Mintz, JD	1
Stepp, DW	1
Sowers, JR	2
Raij, L	2
Jialal, I	1
Egan, BM	2
Ofili, EO	1
Samuel, R	2
Zappe, DH	2
Purkayastha, D	2
Deedwania, PC	1
Franklin, SS	1
Neutel, JM	4
Andalib, A	1
Akhtari, S	1
Rigal, R	1
Curnew, G	1
Leclerc, JM	1
Vaillancourt, M	1
Tardif, JC	1
Fogari, R	2
Mugellini, A	2
Circelli, M	1
Cremonesi, G	1
Komers, R	1
Rogers, S	1
Oyama, TT	1
Xu, B	1
Yang, CL	1
McCormick, J	1
Ellison, DH	1
Hsueh, WA	1
Shojaee, A	1
Maa, JF	1
Weber, MA	1
Jamerson, K	1
Bakris, GL	1
Weir, MR	4
Zappe, D	1
Zhang, Y	1
Dahlof, B	1
Velazquez, EJ	1
Pitt, B	1
Dorresteijn, JA	1
Schrover, IM	1
Visseren, FL	1
Scheffer, PG	1
Oey, PL	1
Danser, AH	1
Spiering, W	1
Egan, B	1
Grassi, G	2
Seravalle, G	1
Dell'Oro, R	1
Trevano, FQ	1
Bombelli, M	1
Scopelliti, F	1
Facchini, A	1
Mancia, G	1
PICO, M	1
WOLF, R	1
DIGIESI, V	1
MORACE, G	1
SCHWARTZ, W	1
RAY, RE	1
Sharma, AM	4
Bramlage, P	2
Kirch, W	2
Ruilope, LM	1
Malacco, E	1
Khder, Y	1
Kandra, A	1
Bönner, G	1
Heintz, D	1
Jordan, J	2
Engeli, S	2
Boschmann, M	1
Weidinger, G	1
Luft, FC	1
Kreuzberg, U	1
Boye, SW	1
Le Breton, S	1
Scholze, J	1
Grimm, E	1
Herrmann, D	1
Unger, T	1
Kintscher, U	1
Davidson, J	1
Koval, S	1
Lacourcière, Y	1
Bhaumik, A	1
De Obaldia, ME	1
Lapuerta, P	1
Derosa, G	1
Zoppi, A	1
Lazzari, P	1
Corradi, L	1
Preti, P	1
Abate, N	1
Chen, E	1
Creager, MA	1
Galet, V	1
Jia, G	1
Julius, S	1
Lerman, A	1
Lyle, PA	1
Pool, J	1
Tershakovec, AM	1
Rosa, EC	1
Zanella, MT	1
Kohlmann, NE	1
Ferreira, SR	1
Plavnik, FL	1
Ribeiro, AB	1
Kohlmann, O	1
Noble, RE	1
Webb, EL	1
Godfrey, JC	1
Zisblatt, M	1
Vukovich, RA	1
Neiss, ES	1
Smith, CL	1
Linner, JH	1
McCrory, WW	1
Lake, CR	1
Ziegler, MG	1
Coleman, MD	1
Kopin, IJ	1
Zhurova, MV	1
Rybina, LV	1
Mehnert, G	1
Reaven, GM	1
Clinkingbeard, C	1
Jeppesen, J	1
Maheux, P	1
Pei, D	1
Foote, J	1
Hollenbeck, CB	1
Chen, YD	1
Bell, DS	1
Zhao, D	1
Siegel, D	1
Saliba, P	1
Haffner, S	1
Reisin, E	2
Falkner, B	2
Hutchinson, HG	2
Anzalone, DA	1
Tuck, ML	2
Velasquez, MT	1
Striffler, JS	1
Abraham, AA	1
Michaelis, OE	1
Scalbert, E	1
Thibault, N	1
Sha, L	1
Kucher, E	1
Miilunpalo, S	1
Saarinen, R	1
Marniemi, J	1
Lehtonen, A	1
Ryvkin, IA	1
Korsunskiĭ, AA	1
Pribylova, LP	1
Lobanova, LS	1
Raĭskaia, AM	1
Mouzet, MT	1
Balsan, S	1
Royer, P	1
Steinberg, AD	1
Kocí, V	1
Drásilová, L	1
Vague, J	1
Miller, G	1
Teitelbaum, M	1
Schelling, JL	1
Moody, AJ	1
Felber, JP	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
Treatment of Essential Hypertension With Rasilez. Evaluation of Different Methods of Blood Pressure Measurements - Efficacy and Safety Evaluation[NCT01060865]	Phase 4	50 participants (Actual)	Interventional	2010-03-31	Terminated (stopped due to The participants signed an old version of the informed consent.)
A 16-week Double-blind, Randomized, Multicenter, Force-titration Study to Evaluate the Antihypertensive Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Therapy Compared to HCTZ Based Therapy in Obese, Hypertensive Patients[NCT00439738]	Phase 4	412 participants (Actual)	Interventional	2006-12-31	Completed
A 10-week Multicenter,Forced-titration Study Using 24-hr ABPM to Evaluate the Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Treatment Regimen vs Conventional Treatment Regimen With Amlodipine and Hydrochlorothiazide (HCTZ) in Patients With Stage 2 Hype[NCT00425997]	Phase 4	480 participants (Anticipated)	Interventional	2006-12-31	Completed
A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy[NCT00791258]	Phase 4	999 participants (Actual)	Interventional	2008-11-30	Completed
A Prospective, Multinational, Multicenter Trial to Compare the Effects of Amlodipine/Benazepril to Benazepril and Hydrochlorothiazide Combined on the Reduction of Cardiovascular Morbidity and Mortality in Patients With High Risk Hypertension[NCT00170950]	Phase 3	11,506 participants (Actual)	Interventional	2003-10-31	Terminated (stopped due to The study was terminated early because of significant efficacy results for the primary endpoint in favor of benazepril/amlodipine treatment.)
Comparative Study of Effect of Valsartan 160mg Treatment Versus Continuous Positive Airway Pressure on Arterial Blood Pressure in Patients Who Have an Obstructive Sleep Apnea Syndrome and a Weak or Moderate Hypertension.[NCT00409487]	Phase 4	60 participants (Anticipated)	Interventional	2006-12-31	Completed
A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Resp[NCT00219115]	Phase 3	493 participants (Actual)	Interventional	2005-01-31	Completed
A Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination With Hydrochlorothiazide Versus Placebo in Obese Patients With Elevated Systolic and Diastolic Blood Pressure[NCT00289887]	Phase 3	261 participants (Actual)	Interventional	2006-02-28	Completed
[NCT00000525]	Phase 3	233 participants (Actual)	Interventional	1986-07-31	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test (NCT00439738)
Timeframe: Week 16

Change From Baseline in Postprandial Insulin

Intervention	mg/dL (Mean)
	Baseline visit (0 minutes)	Week 16 (0 minutes)	Change from baseline to week 16 (0 minutes)	Baseline visit (120 minutes)	Week 16 (120 minutes)	Change from baseline to week 16 (120 minutes)
HCTZ +Amlodipine	99.4	102.8	3.4	127.7	146.5	18.9
Valsartan/HCTZ (Hydrochlorothiazide)	98.0	98.1	-0.5	123.9	126.3	2.1

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test (NCT00439738)
Timeframe: Week 16

Change From Baseline in Postprandial Non-esterified Fatty Acids

Intervention	mg/dL (Mean)
	Baseline visit (0 minutes)	Week 16 (0 minutes)	Change from baseline to week 16 (0 minutes)	Baseline visit (120 minutes)	Week 16 (120 minutes)	Change from baseline to week 16 (120 minute)
HCTZ +Amlodipine	20.37	23.62	3.67	95.95	120.01	28.07
Valsartan/HCTZ (Hydrochlorothiazide)	19.66	23.45	3.41	92.04	116.04	24.68

After a 75 gram anhydrous glucose challenge 2 hours after an oral glucose tolerance test (NCT00439738)
Timeframe: Week 16

Change in Mean Sitting Diastolic Blood Pressure (MSDBP)

Change in Mean Sitting Systolic Blood Pressure (MSSBP)

Number of Patients Achieving Blood Pressure (BP) Control by Visit (< 140/90 mm Hg)

Intervention	mg/dL (Mean)
	Baseline visit (0 minutes)	Week 16 (0 minutes)	Change from baseline to week 16 (0 minutes)	Baseline visit (120 minutes)	Week 16 (120 minutes)	Change from baseline to week 16 (120 minutes)
HCTZ +Amlodipine	0.47	0.47	0.00	0.10	0.10	-0.01
Valsartan/HCTZ (Hydrochlorothiazide)	0.45	0.46	0.01	0.11	0.10	-0.01

Intervention	mm Hg (Mean)
	Baseline	Week 4	Week 8	Week 12	Week 16	Change from baseline to week 16
HCTZ +Amlodipine	93.6	87.6	85.1	82.8	80.9	-12.7
Valsartan/HCTZ (Hydrochlorothiazide)	94.9	85.7	81.9	81.1	80.8	-14.0

Intervention	mm Hg (Mean)
	Baseline	Week 8	Change from baseline
HCTZ +Amlodipine	159.0	137.5	-21.5
Valsartan/HCTZ (Hydrochlorothiazide)	159.7	131.2	-28.6

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 140/90 mm Hg (NCT00439738)
Timeframe: Weeks 4, 8, 12 16 and End of Study (for patients that did not complete the last visit at week 16)

Number of Patients Achieving Blood Pressure (BP)Control by Visit (< 130/80 mm Hg)

Intervention	participants (Number)
	Week 4	Week 8	Week 12	Week 16	End of study
HCTZ +Amlodipine	69	102	112	140	146
Valsartan/HCTZ (Hydrochlorothiazide)	91	123	122	124	133

Mean sitting systolic blood pressure/mean sitting diastolic blood pressure < 130/80 mm Hg (NCT00439738)
Timeframe: Week 4, 8, 12, 16, End of Study (for patients that did not complete the last visit at week 16)

The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks

The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks

Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values

Intervention	participants (Number)
	Week 4	Week 8	Week 12	Week 16	End of Study
HCTZ +Amlodipine	18	23	46	65	68
Valsartan/HCTZ (Hydrochlorothiazide)	33	59	57	62	68

Intervention	Percentage of participants (Number)
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	75.8

Intervention	Percentage of participants (Number)
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	84.3

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8 a.m. to 4 p.m. Nighttime is defined as 10 p.m. to 6 a.m. (NCT00791258)
Timeframe: Baseline to 12 weeks

Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values

Intervention	mm Hg (Mean)
	24-hour mean systolic blood pressure	Mean daytime systolic blood pressure	Mean nighttime systolic blood pressure	Systolic blood pressure - last 2 hours of dose	Systolic blood pressure - last 4 hours of dose	Systolic blood pressure - last 6 hours of dose	24-hour mean diastolic blood pressure	Mean daytime diastolic blood pressure	Mean nighttime diastolic blood pressure	Diastolic blood pressure - last 2 hours of dose	Diastolic blood pressure - last 4 hours of dose	Diastolic blood pressure - last 6 hours of dose
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	-14.8	-16.3	-12.5	-13.6	-13.0	-12.6	-9.4	-10.6	-7.6	-8.6	-8.0	-7.7

Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Intervention	mm Hg (Mean)
	24-hour mean systolic blood pressure	Mean daytime systolic blood pressure	Mean nighttime systolic blood pressure	Systolic blood pressure - last 2 hours of dose	Systolic blood pressure - last 4 hours of dose	Systolic blood pressure - last 6 hours of dose	24-hour mean diastolic blood pressure	Mean daytime diastolic blood pressure	Mean nighttime diastolic blood pressure	Diastolic blood pressure - last 2 hours of dose	Diastolic blood pressure - last 4 hours of dose	Diastolic blood pressure - last 6 hours of dose
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	-21.0	-23.2	-17.5	-19.6	-18.2	-17.9	-13.3	-15.0	-11.1	-12.3	-11.6	-11.3

Intervention	mm Hg (Mean)
	4 weeks, N=975	8 weeks, N=929	12 weeks, N=865	16 weeks, N=797	20 weeks, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	-8.1	-9.1	-11.9	-14.6	-14.5

Intervention	mm Hg (Mean)
	4 weeks, N=975	8 weeks, N=929	12 weeks, N=865	16 weeks, N=797	20 weeks, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	-14.6	-16.6	-21.8	-26.0	-26.8

Intervention	Percentage of Participants (Number)
	4 weeks: <140/90 mm Hg, N=230	4 weeks: <135/80 mm Hg, N=230	4 weeks: <130/80 mm Hg, N=230	4 weeks: <120/80 mm Hg, N=230	8 weeks: <140/90 mm Hg, N=231	8 weeks: <135/80 mm Hg, N=231	8 weeks: <130/80 mm Hg, N=232	8 weeks: <120/80 mm Hg, N=232	12 weeks: <140/90mm Hg, N=232	12 weeks: <135/80 mm Hg, N=232	12 weeks: <130/80 mm Hg, N=232	12 weeks: <120/80 mm Hg, N=232	16 weeks: <140/90 mm Hg, N=232	16 weeks: <135/80 mm Hg, N=232	16 weeks: <130/80 mm Hg, N=232	16 weeks: <120/80 mm Hg, N=232	20 weeks: <140/90 mm Hg, N=232	20 weeks: <135/80 mm Hg, N=232	20 weeks: <130/80 mm Hg, N=232	20 weeks: <120/80 mm Hg, N=232
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	45.7	14.8	10.4	3.9	55.0	23.8	20.8	10.4	68.5	38.4	35.8	16.4	80.6	49.1	47.4	30.6	86.6	57.8	55.2	39.7

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=230	4 weeks: <85 mm Hg, N=230	4 weeks: <80 mm Hg, N=230	8 weeks: <90 mm Hg, N=231	8 weeks: <85 mm Hg, N=231	8 weeks: <80 mm Hg, N=231	12 weeks: <90 mm Hg, N=232	12 weeks: <85 mm Hg, N=232	12 weeks: <80 mm Hg, N=232	16 weeks: <90 mm Hg, N=232	16 weeks: <85 mm Hg, N=232	16 weeks: <80 mm Hg, N=232	20 weeks: <90 mm Hg, N=232	20 weeks: <85 mm Hg, N=232	20 weeks: <80 mm Hg, N=232
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	60.9	42.2	19.6	71.9	53.7	30.3	82.3	66.0	45.3	92.2	76.3	55.2	94.8	80.6	61.2

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=230	4 weeks: >10 and ≤ 15 mm Hg, N=230	4 weeks: >15 and ≤ 20 mm Hg, N=230	4 weeks: >20 mm Hg, N=230	8 weeks: ≤ 10 mm Hg, N=220	8 weeks: >10 and ≤ 15 mm Hg, N=220	8 weeks: >15 and ≤ 20 mm Hg, N=220	8 weeks: >20 mm Hg, N=220	12 weeks: ≤ 10 mm Hg, N=208	12 weeks: >10 and ≤15 mm Hg, N=208	12 weeks: >15 and ≤ 20 mm Hg, N=208	12 weeks: >20 mm Hg, N=208	16 weeks: ≤ 10 mm Hg, N=199	16 weeks: >10 and ≤ 15 mm Hg, N=199	16 weeks: >15 and ≤ 20 mm Hg, N=199	16 weeks: >20 mm Hg, N=199	20 weeks: ≤ 10 mm Hg, N=189	20 weeks: >10 and ≤ 15 mm Hg, N=189	20 weeks: >15 and ≤ 20 mm Hg, N=189	20 weeks: >20 mm Hg, N=189
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	70.0	17.8	7.9	4.4	66.8	15.0	10.9	7.3	54.8	21.2	12.0	12.0	38.7	19.6	23.1	18.6	36.0	19.6	20.6	23.8

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=230	4 weeks: <135 mm Hg, N=230	4 weeks: <130 mm Hg, N=230	4 weeks: <120 mm Hg, N=230	8 weeks: <140 mm Hg, N=231	8 weeks: <135 mm Hg, N=231	8 weeks: <130 mm Hg, N=231	8 weeks: <120 mm Hg, N=231	12 weeks: <140 mm Hg, N=232	12 weeks: <135 mm Hg, N=232	12 weeks: <130 mm Hg, N=232	12 weeks: <120 mm Hg, N=232	16 weeks: <140 mm Hg, N=232	16 weeks: <135 mm Hg, N=232	16 weeks: <130 mm Hg, N=232	16 weeks: <120 mm Hg, N=232	20 weeks: <140 mm Hg, N=232	20 weeks: <135 mm Hg, N=232	20 weeks: <130 mm Hg, N=232	20 weeks: <120 mm Hg, N=232
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	51.7	34.4	19.6	5.7	62.3	44.6	33.8	13.0	76.3	59.1	47.0	19.8	84.9	71.1	61.2	34.1	91.0	80.6	71.1	44.4

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=230	4 weeks: >15 and ≤ 30 mm Hg, N=230	4 weeks: >30 and ≤ 45 mm Hg, N=230	4 weeks: >45 mm Hg, N=230	8 weeks: ≤ 15 mm Hg, N=220	8 weeks: >15 and ≤ 30 mm Hg, N=220	8 weeks: >30 and ≤ 45 mm Hg, N=220	8 weeks: >45 mm Hg, N=220	12 weeks: ≤ 15 mm Hg, N=208	12 weeks: >15 and ≤ 30 mm Hg, N=208	12 weeks: >30 and ≤ 45 mm Hg, N=208	12 weeks: >45 mm Hg, N=208	16 weeks: ≤ 15 mm Hg, N=199	16 weeks: >15 and ≤ 30 mm Hg, N=199	16 weeks: >30 and ≤ 45 mm Hg, N=199	16 weeks: >45 mm Hg, N=199	20 weeks: ≤ 15 mm Hg, N=189	20 weeks: >15 and ≤ 30 mm Hg, N=189	20 weeks: >30 and ≤ 45 mm Hg, N=189	20 weeks: >45 mm Hg, N=189
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	60.0	32.2	7.4	0.4	53.6	38.2	7.3	0.9	38.9	41.8	16.4	2.9	30.7	37.2	25.1	7.0	24.3	37.6	29.6	8.5

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=128	4 weeks: <85 mm Hg, N=128	4 weeks: <80 mm Hg, N=128	8 weeks: <90 mm Hg, N=128	8 weeks: <85 mm Hg, N=128	8 weeks: <80 mm Hg, N=128	12 weeks: <90 mm Hg, N=128	12 weeks: <85 mm Hg, N=128	12 weeks: <80 mm Hg, N=128	16 weeks: <90 mm Hg, N=128	16 weeks: <85 mm Hg, N=128	16 weeks: <80 mm Hg, N=128	20 weeks: <90 mm Hg, N=128	20 weeks: <85 mm Hg, N=128	20 weeks: <80 mm Hg, N=128
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	83.6	69.5	45.3	89.1	79.7	60.2	95.3	87.5	71.1	96.9	93.0	82.0	96.9	93.0	85.2

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=126	4 weeks: >10 and ≤ 15 mm Hg, N=126	4 weeks: >15 and ≤ 20 mm Hg, N=126	4 weeks: >20 mm Hg, N=126	8 weeks: ≤ 10 mm Hg, N=123	8 weeks: >10 and ≤ 15 mm Hg, N=123	8 weeks: >15 and ≤ 20 mm Hg, N=123	8 weeks: >20 mm Hg, N=123	12 weeks: ≤ 10 mm Hg, N=120	12 weeks: >10 and ≤15 mm Hg, N=120	12 weeks: >15 and ≤ 20 mm Hg, N=120	12 weeks: >20 mm Hg, N=120	16 weeks: ≤ 10 mm Hg, N=112	16 weeks: >10 and ≤ 15 mm Hg, N=112	16 weeks: >15 and ≤ 20 mm Hg, N=112	16 weeks: >20 mm Hg, N=112	20 weeks: ≤ 10 mm Hg, N=105	20 weeks: >10 and ≤ 15 mm Hg, N=105	20 weeks: >15 and ≤ 20 mm Hg, N=105	20 weeks: >20 mm Hg, N=105
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	47.6	26.2	13.5	12.7	38.2	24.4	22.0	15.5	33.3	25.8	19.2	21.7	27.7	17.0	20.5	34.8	36.2	16.2	18.1	29.5

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=128	4 weeks: <135 mm Hg, N=128	4 weeks: <130 mm Hg, N=128	4 weeks: <120 mm Hg, N=128	8 weeks: <140 mm Hg, N=128	8 weeks: <135 mm Hg, N=128	8 weeks: <130 mm Hg, N=128	8 weeks: <120 mm Hg, N=128	12 weeks: <140 mm Hg, N=128	12 weeks: <135 mm Hg, N=128	12 weeks: <130 mm Hg, N=128	12 weeks: <120 mm Hg, N=128	16 weeks: <140 mm Hg, N=128	16 weeks: <135 mm Hg, N=128	16 weeks: <130 mm Hg, N=128	16 weeks: <120 mm Hg, N=128	20 weeks: <140 mm Hg, N=128	20 weeks: <135 mm Hg, N=128	20 weeks: <130 mm Hg, N=128	20 weeks: <120 mm Hg, N=128
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	64.8	51.6	35.2	11.7	76.6	67.2	51.6	25.0	89.1	78.9	66.4	38.3	95.3	89.8	81.3	47.7	97.7	93.0	85.9	51.6

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=126	4 weeks: >15 and ≤ 30 mm Hg, N=126	4 weeks: >30 and ≤ 45 mm Hg, N=126	4 weeks: >45 mm Hg, N=126	8 weeks: ≤ 15 mm Hg, N=123	8 weeks: >15 and ≤ 30 mm Hg, N=123	8 weeks: >30 and ≤ 45 mm Hg, N=123	8 weeks: >45 mm Hg, N=123	12 weeks: ≤ 15 mm Hg, N=120	12 weeks: >15 and ≤ 30 mm Hg, N=120	12 weeks: >30 and ≤ 45 mm Hg, N=120	12 weeks: >45 mm Hg, N=120	16 weeks: ≤ 15 mm Hg, N=112	16 weeks: >15 and ≤ 30 mm Hg, N=112	16 weeks: >30 and ≤ 45 mm Hg, N=112	16 weeks: >45 mm Hg, N=112	20 weeks: ≤ 15 mm Hg, N=105	20 weeks: >15 and ≤ 30 mm Hg, N=105	20 weeks: >30 and ≤ 45 mm Hg, N=105	20 weeks: >45 mm Hg, N=105
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	43.7	38.1	15.9	2.4	40.7	35.8	22.0	1.6	28.3	39.2	27.5	5.0	20.5	36.6	31.3	11.6	29.5	28.6	33.3	8.6

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=227	4 weeks: <85 mm Hg, N=227	4 weeks: <80 mm Hg, N=227	8 weeks: <90 mm Hg, N=227	8 weeks: <85 mm Hg, N=227	8 weeks: <80 mm Hg, N=227	12 weeks: <90 mm Hg, N=227	12 weeks: <85 mm Hg, N=227	12 weeks: <80 mm Hg, N=227	16 weeks: <90 mm Hg, N=227	16 weeks: <85 mm Hg, N=227	16 weeks: <80 mm Hg, N=227	20 weeks: <90 mm Hg, N=227	20 weeks: <85 mm Hg, N=227	20 weeks: <80 mm Hg, N=227
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	88.1	76.7	58.2	92.1	83.7	71.8	97.4	92.1	80.2	98.7	94.3	88.6	98.7	95.2	90.3

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=224	4 weeks: >10 and ≤ 15 mm Hg, N=224	4 weeks: >15 and ≤ 20 mm Hg, N=224	4 weeks: >20 mm Hg, N=224	8 weeks: ≤ 10 mm Hg, N=217	8 weeks: >10 and ≤ 15 mm Hg, N=217	8 weeks: >15 and ≤ 20 mm Hg, N=217	8 weeks: >20 mm Hg, N=217	12 weeks: ≤ 10 mm Hg, N=199	12 weeks: >10 and ≤15 mm Hg, N=199	12 weeks: >15 and ≤ 20 mm Hg, N=199	12 weeks: >20 mm Hg, N=199	16 weeks: ≤ 10 mm Hg, N=179	16 weeks: >10 and ≤ 15 mm Hg, N=179	16 weeks: >15 and ≤ 20 mm Hg, N=179	16 weeks: >20 mm Hg, N=179	20 weeks: ≤ 10 mm Hg, N=166	20 weeks: >10 and ≤ 15 mm Hg, N=166	20 weeks: >15 and ≤ 20 mm Hg, N=166	20 weeks: >20 mm Hg, N=166
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	63.8	20.5	9.4	6.3	57.1	19.8	14.3	8.8	45.2	25.1	15.6	14.1	27.4	25.1	22.9	24.6	34.9	20.5	24.1	20.5

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=227	4 weeks: <135 mm Hg, N=227	4 weeks: <130 mm Hg, N=227	4 weeks: <120 mm Hg, N=227	8 weeks: <140 mm Hg, N=227	8 weeks: <135 mm Hg, N=227	8 weeks: <130 mm Hg, N=227	8 weeks: <120 mm Hg, N=227	12 weeks: <140 mm Hg, N=227	12 weeks: <135 mm Hg, N=227	12 weeks: <130 mm Hg, N=227	12 weeks: <120 mm Hg, N=227	16 weeks: <140 mm Hg, N=227	16 weeks: <135 mm Hg, N=227	16 weeks: <130 mm Hg, N=227	16 weeks: <120 mm Hg, N=227	20 weeks: <140 mm Hg, N=227	20 weeks: <135 mm Hg, N=227	20 weeks: <130 mm Hg, N=227	20 weeks: <120 mm Hg, N=227
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	52.0	37.9	23.4	9.7	67.0	57.7	43.6	18.1	80.6	70.0	56.8	28.6	87.7	79.7	70.9	43.6	91.6	85.9	78.9	50.7

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=224	4 weeks: >15 and ≤ 30 mm Hg, N=224	4 weeks: >30 and ≤ 45 mm Hg, N=224	4 weeks: >45 mm Hg, N=224	8 weeks: ≤ 15 mm Hg, N=217	8 weeks: >15 and ≤ 30 mm Hg, N=217	8 weeks: >30 and ≤ 45 mm Hg, N=217	8 weeks: >45 mm Hg, N=217	12 weeks: ≤ 15 mm Hg, N=199	12 weeks: >15 and ≤ 30 mm Hg, N=199	12 weeks: >30 and ≤ 45 mm Hg, N=199	12 weeks: >45 mm Hg, N=199	16 weeks: ≤ 15 mm Hg, N=179	16 weeks: >15 and ≤ 30 mm Hg, N=179	16 weeks: >30 and ≤ 45 mm Hg, N=179	16 weeks: >45 mm Hg, N=179	20 weeks: ≤ 15 mm Hg, N=166	20 weeks: >15 and ≤ 30 mm Hg, N=166	20 weeks: >30 and ≤ 45 mm Hg, N=166	20 weeks: >45 mm Hg, N=166
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	47.3	40.2	11.2	1.3	42.9	37.8	16.6	2.8	26.6	46.7	24.6	2.0	17.9	32.4	39.7	10.1	14.5	37.4	38.0	10.2

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=98	4 weeks: <85 mm Hg, N=98	4 weeks: <80 mm Hg, N=98	8 weeks: <90 mm Hg, N=100	8 weeks: <85 mm Hg, N=100	8 weeks: <80 mm Hg, N=100	12 weeks: <90 mm Hg, N=100	12 weeks: <85 mm Hg, N=100	12 weeks: <80 mm Hg, N=100	16 weeks: <90 mm Hg, N=100	16 weeks: <85 mm Hg, N=100	16 weeks: <80 mm Hg, N=100	20 weeks: <90 mm Hg, N=100	20 weeks: <85 mm Hg, N=100	20 weeks: <80 mm Hg, N=100
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	66.3	53.1	34.7	85.0	70.0	48.0	92.0	78.0	62.0	96.0	90.0	75.0	96.0	90.0	75.0

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=98	4 weeks: >10 and ≤ 15 mm Hg, N=98	4 weeks: >15 and ≤ 20 mm Hg, N=98	4 weeks: >20 mm Hg, N=98	8 weeks: ≤ 10 mm Hg, N=91	8 weeks: >10 and ≤ 15 mm Hg, N=91	8 weeks: >15 and ≤ 20 mm Hg, N=91	8 weeks: >20 mm Hg, N=91	12 weeks: ≤ 10 mm Hg, N=83	12 weeks: >10 and ≤15 mm Hg, N=83	12 weeks: >15 and ≤ 20 mm Hg, N=83	12 weeks: >20 mm Hg, N=83	16 weeks: ≤ 10 mm Hg, N=75	16 weeks: >10 and ≤ 15 mm Hg, N=75	16 weeks: >15 and ≤ 20 mm Hg, N=75	16 weeks: >20 mm Hg, N=75	20 weeks: ≤ 10 mm Hg, N=71	20 weeks: >10 and ≤ 15 mm Hg, N=71	20 weeks: >15 and ≤ 20 mm Hg, N=71	20 weeks: >20 mm Hg, N=71
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	65.3	16.3	8.2	10.2	52.8	18.7	14.3	14.3	41.0	20.5	14.5	24.1	30.7	25.3	16.0	28.0	31.0	12.7	26.8	29.6

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=98	4 weeks: <135 mm Hg, N=98	4 weeks: <130 mm Hg, N=98	4 weeks: <120 mm Hg, N=98	8 weeks: <140 mm Hg, N=100	8 weeks: <135 mm Hg, N=100	8 weeks: <130 mm Hg, N=100	8 weeks: <120 mm Hg, N=100	12 weeks: <140 mm Hg, N=100	12 weeks: <135 mm Hg, N=100	12 weeks: <130 mm Hg, N=100	12 weeks: <120 mm Hg, N=100	16 weeks: <140 mm Hg, N=100	16 weeks: <135 mm Hg, N=100	16 weeks: <130 mm Hg, N=100	16 weeks: <120 mm Hg, N=100	20 weeks: <140 mm Hg, N=100	20 weeks: <135 mm Hg, N=100	20 weeks: <130 mm Hg, N=100	20 weeks: <120 mm Hg, N=100
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	55.1	39.8	31.6	10.2	64.0	51.0	41.0	15.0	77.0	67.0	54.0	30.0	84.0	77.0	66.0	37.0	88.0	83.0	72.0	41.0

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=98	4 weeks: >15 and ≤ 30 mm Hg, N=98	4 weeks: >30 and ≤ 45 mm Hg, N=98	4 weeks: >45 mm Hg, N=98	8 weeks: ≤ 15 mm Hg, N=91	8 weeks: >15 and ≤ 30 mm Hg, N=91	8 weeks: >30 and ≤ 45 mm Hg, N=91	8 weeks: >45 mm Hg, N=91	12 weeks: ≤ 15 mm Hg, N=83	12 weeks: >15 and ≤ 30 mm Hg, N=83	12 weeks: >30 and ≤ 45 mm Hg, N=83	12 weeks: >45 mm Hg, N=83	16 weeks: ≤ 15 mm Hg, N=75	16 weeks: >15 and ≤ 30 mm Hg, N=75	16 weeks: >30 and ≤ 45 mm Hg, N=75	16 weeks: >45 mm Hg, N=75	20 weeks: ≤ 15 mm Hg, N=71	20 weeks: >15 and ≤ 30 mm Hg, N=71	20 weeks: >30 and ≤ 45 mm Hg, N=71	20 weeks: >45 mm Hg, N=71
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	50.0	37.8	7.1	5.1	42.9	44.0	9.9	3.3	31.3	36.1	25.3	7.2	22.7	36.0	34.7	6.7	23.9	33.8	33.8	8.5

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=497	4 weeks: <85 mm Hg, N=497	4 weeks: <80 mm Hg, N=497	8 weeks: <90 mm Hg, N=497	8 weeks: <85 mm Hg, N=500	8 weeks: <80 mm Hg, N=500	12 weeks: <90 mm Hg, N=500	12 weeks: <85 mm Hg, N=500	12 weeks: <80 mm Hg, N=500	16 weeks: <90 mm Hg, N=500	16 weeks: <85 mm Hg, N=500	16 weeks: <80 mm Hg, N=500	20 weeks: <90 mm Hg, N=500	20 weeks: <85 mm Hg, N=500	20 weeks: <80 mm Hg, N=500
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	63.2	46.3	26.0	77.2	59.4	38.8	86.6	69.8	48.4	93.2	80.4	60.4	94.6	83.8	67.6

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=495	4 weeks: >10 and ≤ 15 mm Hg, N=495	4 weeks: >15 and ≤ 20 mm Hg, N=495	4 weeks: >20 mm Hg, N=495	8 weeks: ≤ 10 mm Hg, N=468	8 weeks: >10 and ≤ 15 mm Hg, N=468	8 weeks: >15 and ≤ 20 mm Hg, N=468	8 weeks: >20 mm Hg, N=468	12 weeks: ≤ 10 mm Hg, N=436	12 weeks: >10 and ≤15 mm Hg, N=436	12 weeks: >15 and ≤ 20 mm Hg, N=436	12 weeks: >20 mm Hg, N=436	16 weeks: ≤ 10 mm Hg, N=400	16 weeks: >10 and ≤ 15 mm Hg, N=400	16 weeks: >15 and ≤ 20 mm Hg, N=400	16 weeks: >20 mm Hg, N=400	20 weeks: ≤ 10 mm Hg, N=379	20 weeks: >10 and ≤ 15 mm Hg, N=379	20 weeks: >15 and ≤ 20 mm Hg, N=379	20 weeks: >20 mm Hg, N=379
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	67.5	17.8	8.5	6.3	59.4	19.9	13.0	7.7	48.9	22.5	16.1	12.6	33.3	23.0	19.0	24.8	31.9	18.7	22.4	26.9

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=497	4 weeks: <135 mm Hg, N=497	4 weeks: <130 mm Hg, N=497	4 weeks: <120 mm Hg, N=497	8 weeks: <140 mm Hg, N=500	8 weeks: <135 mm Hg, N=500	8 weeks: <130 mm Hg, N=500	8 weeks: <120 mm Hg, N=500	12 weeks: <140 mm Hg, N=500	12 weeks: <135 mm Hg, N=500	12 weeks: <130 mm Hg, N=500	12 weeks: <120 mm Hg, N=500	16 weeks: <140 mm Hg, N=500	16 weeks: <135 mm Hg, N=500	16 weeks: <130 mm Hg, N=500	16 weeks: <120 mm Hg, N=500	20 weeks: <140 mm Hg, N=500	20 weeks: <135 mm Hg, N=500	20 weeks: <130 mm Hg, N=500	20 weeks: <120 mm Hg, N=500
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	51.3	37.2	23.3	7.9	63.2	49.2	37.0	13.8	76.6	61.6	49.2	23.2	85.8	75.6	63.6	34.6	90.2	82.6	72.2	43.0

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=495	4 weeks: >15 and ≤ 30 mm Hg, N=495	4 weeks: >30 and ≤ 45 mm Hg, N=495	4 weeks: >45 mm Hg, N=495	8 weeks: ≤ 15 mm Hg, N=468	8 weeks: >15 and ≤ 30 mm Hg, N=468	8 weeks: >30 and ≤ 45 mm Hg, N=468	8 weeks: >45 mm Hg, N=468	12 weeks: ≤ 15 mm Hg, N=436	12 weeks: >15 and ≤ 30 mm Hg, N=436	12 weeks: >30 and ≤ 45 mm Hg, N=436	12 weeks: >45 mm Hg, N=436	16 weeks: ≤ 15 mm Hg, N=400	16 weeks: >15 and ≤ 30 mm Hg, N=400	16 weeks: >30 and ≤ 45 mm Hg, N=400	16 weeks: >45 mm Hg, N=400	20 weeks: ≤ 15 mm Hg, N=379	20 weeks: >15 and ≤ 30 mm Hg, N=379	20 weeks: >30 and ≤ 45 mm Hg, N=379	20 weeks: >45 mm Hg, N=379
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	56.0	35.2	8.5	0.4	52.4	35.9	10.3	1.5	37.8	42.4	17.4	2.5	27.8	36.0	27.5	8.8	20.6	37.5	33.3	8.7

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. (NCT00791258)
Timeframe: Baseline to 12 weeks

Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Intervention	Percentage of participants (Number)
	24-hour mean systolic blood pressure <140 mmHg	24-hour mean systolic blood pressure <135 mmHg	24-hour mean systolic blood pressure <130 mmHg	24-hour mean systolic blood pressure <120 mmHg	24-hour mean diastolic blood pressure <90 mmHg	24-hour mean diastolic blood pressure <85 mmHg	24-hour mean diastolic blood pressure <80 mmHg	24-hour mean blood pressure <140/90 mmHg	24-hour mean blood pressure <135/95 mmHg	24-hour mean blood pressure <135/80 mmHg	24-hour mean blood pressure <130/80 mmHg	24-hour mean blood pressure <125/75 mmHg	24-hour mean blood pressure <120/80 mmHg	24-hour mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	95.6	90.4	79.9	47.2	98.7	96.1	84.7	94.3	89.1	80.3	73.4	52.4	45.9	27.5

Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Intervention	Percentage of participants (Number)
	24-hour mean systolic blood pressure <140 mmHg	24-hour mean systolic blood pressure <135 mmHg	24-hour mean systolic blood pressure <130 mmHg	24-hour mean systolic blood pressure <120 mmHg	24-hour mean diastolic blood pressure <90 mmHg	24-hour mean diastolic blood pressure <85 mmHg	24-hour mean diastolic blood pressure <80 mmHg	24-hour mean blood pressure <140/90 mmHg	24-hour mean blood pressure <135/95 mmHg	24-hour mean blood pressure <135/80 mmHg	24-hour mean blood pressure <130/80 mmHg	24-hour mean blood pressure <125/75 mmHg	24-hour mean blood pressure <120/80 mmHg	24-hour mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	99.5	97.5	94.5	70.4	100.0	97.5	93.0	99.5	96.0	92.5	90.5	75.4	70.4	55.3

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Daytime is defined as 8AM - 4PM. (NCT00791258)
Timeframe: Baseline to 12 weeks

Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Intervention	Percentage of participants (Number)
	Daytime mean systolic blood pressure <140 mmHg	Daytime mean systolic blood pressure <135 mmHg	Daytime mean systolic blood pressure <130 mmHg	Daytime mean systolic blood pressure <120 mmHg	Daytime mean diastolic blood pressure <90 mmHg	Daytime mean diastolic blood pressure <85 mmHg	Daytime mean diastolic blood pressure <80 mmHg	Daytime mean blood pressure <140/90 mmHg	Daytime mean blood pressure <135/95 mmHg	Daytime mean blood pressure <135/80 mmHg	Daytime mean blood pressure <130/80 mmHg	Daytime mean blood pressure <125/75 mmHg	Daytime mean blood pressure <120/80 mmHg	Daytime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	88.2	79.9	66.4	28.8	95.6	83.0	65.5	86.9	72.9	61.1	53.3	31.9	27.9	13.1

Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks

Intervention	Percentage of participants (Number)
	Daytime mean systolic blood pressure <140 mmHg	Daytime mean systolic blood pressure <135 mmHg	Daytime mean systolic blood pressure <130 mmHg	Daytime mean systolic blood pressure <120 mmHg	Daytime mean diastolic blood pressure <90 mmHg	Daytime mean diastolic blood pressure <85 mmHg	Daytime mean diastolic blood pressure <80 mmHg	Daytime mean blood pressure <140/90 mmHg	Daytime mean blood pressure <135/95 mmHg	Daytime mean blood pressure <135/80 mmHg	Daytime mean blood pressure <130/80 mmHg	Daytime mean blood pressure <125/75 mmHg	Daytime mean blood pressure <120/80 mmHg	Daytime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	96.5	93.5	83.9	51.8	98.5	92.5	83.9	95.0	88.4	81.9	77.4	56.8	51.3	33.2

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10p.m. - 6 a.m. (NCT00791258)
Timeframe: Baseline to 12 weeks

Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks

Intervention	Percentage of participants (Number)
	Nighttime mean systolic blood pressure <140 mmHg	Nighttime mean systolic blood pressure <135 mmHg	Nighttime mean systolic blood pressure <130 mmHg	Nighttime mean systolic blood pressure <120 mmHg	Nighttime mean diastolic blood pressure <90 mmHg	Nighttime mean diastolic blood pressure <85 mmHg	Nighttime mean diastolic blood pressure <80 mmHg	Nighttime mean blood pressure <140/90 mmHg	Nighttime mean blood pressure <135/95 mmHg	Nighttime mean blood pressure <135/80 mmHg	Nighttime mean blood pressure <130/80 mmHg	Nighttime mean blood pressure <125/75 mmHg	Nighttime mean blood pressure <120/80 mmHg	Nighttime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	97.8	94.3	92.6	74.7	99.6	98.3	94.8	97.4	93.4	90.8	89.1	77.7	74.2	62.0

Once the Ambulatory Blood Pressure Monitor (ABPM) has been applied, the dose of medication was taken and the subject wore the ABPM for a period of 24 hours. Nighttime is defined as 10 p.m. - 6 a.m. (NCT00791258)
Timeframe: Baseline to 20 weeks

Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks

Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks

Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks

Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks

The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks

Time-to-event Analysis of Percentage of Patients With a Cardiovascular (CV) Mortality Event, Non-fatal Myocardial Infarction (MI), or Non-fatal Stroke

Intervention	Percentage of participants (Number)
	Nighttime mean systolic blood pressure <140 mmHg	Nighttime mean systolic blood pressure <135 mmHg	Nighttime mean systolic blood pressure <130 mmHg	Nighttime mean systolic blood pressure <120 mmHg	Nighttime mean diastolic blood pressure <90 mmHg	Nighttime mean diastolic blood pressure <85 mmHg	Nighttime mean diastolic blood pressure <80 mmHg	Nighttime mean blood pressure <140/90 mmHg	Nighttime mean blood pressure <135/95 mmHg	Nighttime mean blood pressure <135/80 mmHg	Nighttime mean blood pressure <130/80 mmHg	Nighttime mean blood pressure <125/75 mmHg	Nighttime mean blood pressure <120/80 mmHg	Nighttime mean blood pressure <120/70 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	99.5	99.5	97.5	86.4	99.5	98.5	96.0	99.0	98.5	96.0	95.0	88.9	85.9	78.9

Intervention	Percentage of participants (Number)
	Systolic blood pressure <140 mmHg	Systolic blood pressure <135 mmHg	Systolic blood pressure <130 mmHg	Systolic blood pressure <120 mmHg	Diastolic blood pressure <90 mmHg	Diastolic blood pressure <85 mmHg	Diastolic blood pressure <80 mmHg	Blood pressure <140/90 mmHg	Blood pressure <135/80 mmHg	Blood pressure <130/80 mmHg	Blood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	88.5	75.2	62.0	33.6	94.7	83.2	61.1	86.7	55.8	49.6	29.2

Intervention	Percentage of participants (Number)
	Systolic blood pressure <140 mmHg	Systolic blood pressure <135 mmHg	Systolic blood pressure <130 mmHg	Systolic blood pressure <120 mmHg	Diastolic blood pressure <90 mmHg	Diastolic blood pressure <85 mmHg	Diastolic blood pressure <80 mmHg	Blood pressure <140/90 mmHg	Blood pressure <135/80 mmHg	Blood pressure <130/80 mmHg	Blood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	93.8	87.6	79.7	47.8	98.2	89.4	77.0	92.9	74.3	69.9	43.4

Intervention	Percentage of participants (Number)
	Systolic blood pressure <140 mmHg	Systolic blood pressure <135 mmHg	Systolic blood pressure <130 mmHg	Systolic blood pressure <120 mmHg	Diastolic blood pressure <90 mmHg	Diastolic blood pressure <85 mmHg	Diastolic blood pressure <80 mmHg	Blood pressure <140/90 mmHg	Blood pressure <135/80 mmHg	Blood pressure <130/80 mmHg	Blood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	73.5	59.0	47.9	18.8	86.3	72.7	48.7	68.4	40.2	34.2	16.2

Intervention	Percentage of participants (Number)
	Systolic blood pressure <140 mmHg	Systolic blood pressure <135 mmHg	Systolic blood pressure <130 mmHg	Systolic blood pressure <120 mmHg	Diastolic blood pressure <90 mmHg	Diastolic blood pressure <85 mmHg	Diastolic blood pressure <80 mmHg	Blood pressure <140/90 mmHg	Blood pressure <135/80 mmHg	Blood pressure <130/80 mmHg	Blood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	89.7	83.8	69.2	41.0	91.5	85.5	69.2	85.5	64.1	59.8	36.8

Intervention	Percentage of participants (Number)
	Systolic blood pressure <140 mmHg	Systolic blood pressure <135 mmHg	Systolic blood pressure <130 mmHg	Systolic blood pressure <120 mmHg	Diastolic blood pressure <90 mmHg	Diastolic blood pressure <85 mmHg	Diastolic blood pressure <80 mmHg	Blood pressure <140/90 mmHg	Blood pressure <135/80 mmHg	Blood pressure <130/80 mmHg	Blood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	92.8	82.5	78.3	51.2	94.6	86.8	71.7	88.6	67.5	65.1	48.2

Intervention	Percentage of participants (Number)
	Systolic blood pressure <140 mmHg	Systolic blood pressure <135 mmHg	Systolic blood pressure <130 mmHg	Systolic blood pressure <120 mmHg	Diastolic blood pressure <90 mmHg	Diastolic blood pressure <85 mmHg	Diastolic blood pressure <80 mmHg	Blood pressure <140/90 mmHg	Blood pressure <135/80 mmHg	Blood pressure <130/80 mmHg	Blood pressure <120/80 mmHg
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	92.8	82.5	78.3	51.2	94.6	86.8	71.7	88.6	67.5	65.1	48.2

CV mortality was defined as death due to sudden cardiac death, fatal MI, fatal stroke, coronary intervention, congestive heart failure (CHF), or other CV causes. (NCT00170950)
Timeframe: For each patient, baseline to time of first CV mortality event, MI (non-fatal), or stroke (non-fatal) (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])

Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity Event

Cardiovascular morbidity was defined as including any of the following events: non-fatal MI, non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure (PCI or CABG). (NCT00170950)
Timeframe: For each patient, baseline to time of first CV morbidity event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])]

Time-to-event Analysis of Percentage of Patients With a Composite Cardiovascular (CV) Morbidity or Mortality Event

CV morbidity was defined as non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina, resuscitated sudden death, or coronary revascularization procedure. CV mortality was defined as death due to MI, stroke, coronary intervention, congestive heart failure (CHF), sudden cardiac death, or other CV causes. (NCT00170950)
Timeframe: For each patient, baseline to time of first CV morbidity or mortality event (or last exposure if no event occurred). (Median duration of exposure was 33.4 months. [25th to 75th percentiles: 21 to 41 months.])

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 12

"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline." (NCT00289887)
Timeframe: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 16

"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline." (NCT00289887)
Timeframe: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Mean Change From Baseline in Trough Sitting Diastolic Blood Pressure (SiDBP) at Week 8

"Mean change from baseline in trough (6 hours after the last morning dose) SiDBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline." (NCT00289887)
Timeframe: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 12

"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 12.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline." (NCT00289887)
Timeframe: At baseline and at 12 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 16

"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 16.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline." (NCT00289887)
Timeframe: At baseline and at 16 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Mean Change From Baseline in Trough Sitting Systolic Blood Pressure (SiSBP) at Week 8

"Mean change from baseline in trough (6 hours after last morning dose) SiSBP at Week 8.~A mixed effects model (with repeated measurements including terms of treatment, investigators, week, baseline SiSBP(/SiDBP), plasma glucose stratum, treatment*week, and week*SiSBP(/SiDBP)) was used to compare the treatments on the change from baseline." (NCT00289887)
Timeframe: At baseline and at 8 weeks (with the measurements taken prior to the morning dose, between 6 AM and 10 AM)

Intervention	Percentage of Participants (Number)
	4 weeks: <140/90 mm Hg, N=975	4 weeks: <135/80 mm Hg, N=975	4 weeks: <130/80 mm Hg, N=975	4 weeks: <120/80 mm Hg, N=975	8 weeks: <140/90 mm Hg, N=929	8 weeks: <135/80 mm Hg, N=929	8 weeks: <130/80 mm Hg, N=929	8 weeks: <120/80 mm Hg, N=929	12 weeks: <140/90 mm Hg, N=865	12 weeks: <135/80 mm Hg, N=865	12 weeks: <130/80 mm Hg, N=865	12 weeks: <120/80 mm Hg, N=865	16 weeks: <140/90mm Hg, N=797	16 weeks: <135/80mm Hg, N=797	16 weeks: <130/80mm Hg, N=797	16 weeks: <120/80mm Hg, N=797	20 weeks: <140/90 mm Hg, N=745	20 weeks: <135/80 mm Hg, N=745	20 weeks: <130/80 mm Hg, N=745	20 weeks: <120/80 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	49.1	23.0	17.3	7.8	52.4	29.8	24.8	11.2	68.1	40.0	34.3	17.6	77.8	51.3	46.2	28.7	81.3	55.6	50.1	28.2

Intervention	Percentage of participants (Number)
	4 weeks: <90 mm Hg, N=975	4weeks: <85 mm Hg, N=975	4 weeks: <80 mm Hg, N=975	8 weeks: <90 mm Hg, N=929	8 weeks: <85 mm Hg, N=929	8 weeks: <80 mm Hg, N=929	12 weeks: <90 mm Hg, N=865	12 weeks: <85 mm Hg, N=865	12 weeks: <80 mm Hg, N=865	16 weeks: <90 mm Hg, N=797	16 weeks: <85 mm Hg, N=797	16 weeks: <80 mm Hg, N=797	20 weeks: <90 mm Hg, N=745	20 weeks: <85 mm Hg, N=745	20 weeks: <80 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	71.3	55.2	34.2	75.1	57.1	40.2	84.3	68.7	49.5	90.2	76.9	59.6	89.7	79.5	62.0

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=975	4 weeks: >10 and ≤ 15 mm Hg, N=975	4 weeks: >15 and ≤ 20 mm Hg, N=975	4 weeks: >20 mm Hg, N=975	8 weeks: ≤ 10 mm Hg, N=929	8 weeks: >10 and ≤ 15 mm Hg, N=929	8 weeks: >15 and ≤ 20 mm Hg, N=929	8 weeks: >20 mm Hg, N=929	12 weeks: ≤ 10 mm Hg, N=865	12 weeks: >10 and ≤ 15 mm Hg, N=865	12 weeks: >15 and ≤ 20 mm Hg, N=865	12 weeks: >20 mm Hg, N=865	16 weeks: ≤ 10 mm Hg, N=797	16 weeks: >10 and ≤ 15 mm Hg, N=797	16 weeks: >15 and ≤ 20 mm Hg, N=797	16 weeks: >20 mm Hg, N=797	20 weeks: ≤ 10 mm Hg, N=745	20 weeks: >10 and ≤ 15 mm Hg, N=745	20 weeks: >15 and ≤ 20 mm Hg, N=745	20 weeks: >20 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	61.3	21.0	10.5	7.2	54.7	20.7	14.1	10.6	43.8	24.1	15.8	16.3	30.4	22.8	21.5	25.4	31.4	19.9	22.6	26.2

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=975	4 weeks: <135 mm Hg, N=975	4 weeks: <130 mm Hg, N=975	4 weeks: <120 mm Hg, N=975	8 weeks: <140 mm Hg, N=929	8 weeks: <135 mm Hg, N=929	8 weeks: <130 mm Hg, N=929	8 weeks: <120 mm Hg, N=929	12 weeks: <140 mm Hg, N=865	12 weeks: <135 mm Hg, N=865	12 weeks: <130 mm Hg, N=865	12 weeks: <120 mm Hg, N=865	16 weeks: <140 mm Hg, N=797	16 weeks: <135 mm Hg, N=797	16 weeks: <130 mm Hg, N=797	16 weeks: <120 mm Hg, N=797	20 weeks: <140 mm Hg, N=745	20 weeks: <135 mm Hg, N=745	20 weeks: <130 mm Hg, N=745	20 weeks: <120 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	54.2	39.8	25.3	8.9	57.2	45.9	35.0	12.9	72.6	59.0	45.3	19.4	80.9	70.3	58.9	30.9	84.3	75.2	64.2	31.5

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=975	4 weeks: >15 and ≤ 30 mm Hg, N=975	4 weeks: >30 and ≤ 45 mm Hg, N=975	4 weeks: >45 mm Hg, N=975	8 weeks: ≤ 15 mm Hg, N=929	8 weeks: >15 and ≤ 30 mm Hg, N=929	8 weeks: >30 and ≤ 45 mm Hg, N=929	8 weeks: >45 mm Hg, N=929	12 weeks: ≤ 15 mm Hg, N=865	12 weeks: >15 and ≤ 30 mm Hg, N=865	12 weeks: >30 and ≤ 45 mm Hg, N=865	12 weeks: >45 mm Hg, N=865	16 weeks: ≤ 15 mm Hg, N=797	16 weeks: >15 and ≤ 30 mm Hg, N=797	16 weeks: >30 and ≤ 45 mm Hg, N=797	16 weeks: >45 mm Hg, N=797	20 weeks: ≤ 15 mm Hg, N=745	20 weeks: >15 and ≤ 30 mm Hg, N=745	20 weeks: >30 and ≤ 45 mm Hg, N=745	20 weeks: >45 mm Hg, N=745
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	51.4	36.6	10.5	1.5	45.8	37.7	14.3	2.3	30.5	43.1	22.4	3.9	23.2	35.9	32.0	8.9	20.4	36.2	34.0	9.4

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=454	4 weeks: <85 mm Hg, N=454	4 weeks: <80 mm Hg, N=454	8 weeks: <90 mm Hg, N=457	8 weeks: <85 mm Hg, N=457	8 weeks: <80 mm Hg, N=457	12 weeks: <90 mm Hg, N=457	12 weeks: <85 mm Hg, N=457	12 weeks: <80 mm Hg, N=457	16 weeks: <90 mm Hg, N=457	16 weeks: <85 mm Hg, N=457	16 weeks: <80 mm Hg, N=457	20 weeks: <90 mm Hg, N=457	20 weeks: <85 mm Hg, N=457	20 weeks: <80 mm Hg, N=457
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	69.6	53.5	31.9	82.1	66.1	43.5	90.4	76.6	56.5	94.8	83.2	65.9	95.4	86.2	72.0

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=453	4 weeks: >10 and ≤ 15 mm Hg, N=453	4 weeks: >15 and ≤ 20 mm Hg, N=453	4 weeks: >20 mm Hg, N=453	8 weeks: ≤ 10 mm Hg, N=431	8 weeks: >10 and ≤ 15 mm Hg, N=431	8 weeks: >15 and ≤ 20 mm Hg, N=431	8 weeks: >20 mm Hg, N=431	12 weeks: ≤ 10 mm Hg, N=402	12 weeks: >10 and ≤15 mm Hg, N=402	12 weeks: >15 and ≤ 20 mm Hg, N=402	12 weeks: >20 mm Hg, N=402	16 weeks: ≤ 10 mm Hg, N=371	16 weeks: >10 and ≤ 15 mm Hg, N=371	16 weeks: >15 and ≤ 20 mm Hg, N=371	16 weeks: >20 mm Hg, N=371	20 weeks: ≤ 10 mm Hg, N=356	20 weeks: >10 and ≤ 15 mm Hg, N=356	20 weeks: >15 and ≤ 20 mm Hg, N=356	20 weeks: >20 mm Hg, N=356
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	62.7	22.3	8.6	6.4	56.6	19.7	15.3	8.4	44.3	22.1	17.4	16.2	32.4	24.0	21.0	22.6	33.2	19.4	22.5	25.0

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=454	4 weeks: <135 mm Hg, N=454	4 weeks: <130 mm Hg, N=454	4 weeks: <120 mm Hg, N=454	8 weeks: <140 mm Hg, N=457	8 weeks: <135 mm Hg, N=457	8 weeks: <130 mm Hg, N=457	8 weeks: <120 mm Hg, N=457	12 weeks: <140 mm Hg, N=457	12 weeks: <135 mm Hg, N=457	12 weeks: <130 mm Hg, N=457	12 weeks: <120 mm Hg, N=457	16 weeks: <140 mm Hg, N=457	16 weeks: <135 mm Hg, N=457	16 weeks: <130 mm Hg, N=457	16 weeks: <120 mm Hg, N=457	20 weeks: <140 mm Hg, N=457	20 weeks: <135 mm Hg, N=457	20 weeks: <130 mm Hg, N=457	20 weeks: <120 mm Hg, N=457
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	56.4	41.4	27.1	7.9	67.6	54.3	40.9	16.2	81.4	67.2	54.1	27.6	88.8	80.3	67.0	39.0	91.5	85.6	74.8	47.1

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=453	4 weeks: >15 and ≤ 30 mm Hg, N=453	4 weeks: >30 and ≤ 45 mm Hg, N=453	4 weeks: >45 mm Hg, N=453	8 weeks: ≤ 15 mm Hg, N=431	8 weeks: >15 and ≤ 30 mm Hg, N=431	8 weeks: >30 and ≤ 45 mm Hg, N=431	8 weeks: >45 mm Hg, N=431	12 weeks: ≤ 15 mm Hg, N=402	12 weeks: >15 and ≤ 30 mm Hg, N=402	12 weeks: >30 and ≤ 45 mm Hg, N=402	12 weeks: >45 mm Hg, N=402	16 weeks: ≤ 15 mm Hg, N=371	16 weeks: >15 and ≤ 30 mm Hg, N=371	16 weeks: >30 and ≤ 45 mm Hg, N=371	16 weeks: >45 mm Hg, N=371	20 weeks: ≤ 15 mm Hg, N=356	20 weeks: >15 and ≤ 30 mm Hg, N=356	20 weeks: >30 and ≤ 45 mm Hg, N=356	20 weeks: >45 mm Hg, N=356
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	49.5	38.4	11.5	0.7	48.0	35.5	14.4	2.1	30.4	43.8	22.6	3.2	24.0	37.7	29.1	9.2	19.7	36.5	36.0	7.9

Intervention	Percentage of Participants (Number)
	4 weeks: <90 mm Hg, N=190	4 weeks: <85 mm Hg, N=190	4 weeks: <80 mm Hg, N=190	8 weeks: <90 mm Hg, N=190	8 weeks: <85 mm Hg, N=190	8 weeks: <80 mm Hg, N=190	12 weeks: <90 mm Hg, N=190	12 weeks: <85 mm Hg, N=190	12 weeks: <80 mm Hg, N=190	16 weeks: <90 mm Hg, N=190	16 weeks: <85 mm Hg, N=190	16 weeks: <80 mm Hg, N=190	20 weeks: <90 mm Hg, N=190	20 weeks: <85 mm Hg, N=190	20 weeks: <80 mm Hg, N=190
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	75.8	64.2	39.0	85.8	72.6	51.1	94.2	83.2	63.7	97.9	89.0	70.5	99.0	90.5	76.8

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 10 mm Hg, N=189	4 weeks: >10 and ≤ 15 mm Hg, N=189	4 weeks: >15 and ≤ 20 mm Hg, N=189	4 weeks: >20 mm Hg, N=189	8 weeks: ≤ 10 mm Hg, N=181	8 weeks: >10 and ≤ 15 mm Hg, N=181	8 weeks: >15 and ≤ 20 mm Hg, N=181	8 weeks: >20 mm Hg, N=181	12 weeks: ≤ 10 mm Hg, N=170	12 weeks: >10 and ≤15 mm Hg, N=170	12 weeks: >15 and ≤ 20 mm Hg, N=170	12 weeks: >20 mm Hg, N=170	16 weeks: ≤ 10 mm Hg, N=156	16 weeks: >10 and ≤ 15 mm Hg, N=156	16 weeks: >15 and ≤ 20 mm Hg, N=156	16 weeks: >20 mm Hg, N=156	20 weeks: ≤ 10 mm Hg, N=150	20 weeks: >10 and ≤ 15 mm Hg, N=150	20 weeks: >15 and ≤ 20 mm Hg, N=150	20 weeks: >20 mm Hg, N=150
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	67.7	16.9	11.6	3.7	60.8	20.4	14.9	3.9	41.2	32.4	12.9	13.5	32.7	26.9	21.8	18.6	37.3	18.0	26.0	18.7

Intervention	Percentage of Participants (Number)
	4 weeks: <140 mm Hg, N=190	4 weeks: <135 mm Hg, N=190	4 weeks: <130 mm Hg, N=190	4 weeks: <120 mm Hg, N=190	8 weeks: <140 mm Hg, N=190	8 weeks: <135 mm Hg, N=190	8 weeks: <130 mm Hg, N=190	8 weeks: <120 mm Hg, N=190	12 weeks: <140 mm Hg, N=190	12 weeks: <135 mm Hg, N=190	12 weeks: <130 mm Hg, N=190	12 weeks: <120 mm Hg, N=190	16 weeks: <140 mm Hg, N=190	16 weeks: <135 mm Hg, N=190	16 weeks: <130 mm Hg, N=190	16 weeks: <120 mm Hg, N=190	20 weeks: <140 mm Hg, N=190	20 weeks: <135 mm Hg, N=190	20 weeks: <130 mm Hg, N=190	20 weeks: <120 mm Hg, N=190
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	54.7	41.1	26.3	10.0	69.0	56.3	42.6	15.8	81.6	69.5	57.9	30.0	87.9	79.0	69.0	39.5	91.1	84.2	75.3	48.4

Intervention	Percentage of Participants (Number)
	4 weeks: ≤ 15 mm Hg, N=189	4 weeks: >15 and ≤ 30 mm Hg, N=189	4 weeks: >30 and ≤ 45 mm Hg, N=189	4 weeks: >45 mm Hg, N=189	8 weeks: ≤ 15 mm Hg, N=181	8 weeks: >15 and ≤ 30 mm Hg, N=181	8 weeks: >30 and ≤ 45 mm Hg, N=181	8 weeks: >45 mm Hg, N=181	12 weeks: ≤ 15 mm Hg, N=170	12 weeks: >15 and ≤ 30 mm Hg, N=170	12 weeks: >30 and ≤ 45 mm Hg, N=170	12 weeks: >45 mm Hg, N=170	16 weeks: ≤ 15 mm Hg, N=156	16 weeks: >15 and ≤ 30 mm Hg, N=156	16 weeks: >30 and ≤ 45 mm Hg, N=156	16 weeks: >45 mm Hg, N=156	20 weeks: ≤ 15 mm Hg, N=150	20 weeks: >15 and ≤ 30 mm Hg, N=150	20 weeks: >30 and ≤ 45 mm Hg, N=150	20 weeks: >45 mm Hg, N=150
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	56.1	36.0	7.9	0.0	54.1	34.3	11.6	0.0	35.3	38.2	22.9	3.5	28.2	40.4	26.3	5.1	26.0	40.0	26.7	7.3

Intervention	Percentage of participants (Number)
	12 weeks	20 weeks
Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide	71.3	84.8

Article	Year
Combination delapril/manidipine as antihypertensive therapy in high-risk patients. Clinical drug investigation, 2011, Volume: 31, Issue:7 Topics: Antihypertensive Agents; Biphenyl Compounds; Blood Pressure; Clinical Trials as Topic; Diabetes Comp	2011
Insulin resistance. An often unrecognized problem accompanying chronic medical disorders. Postgraduate medicine, 1993, May-15, Volume: 93, Issue:7 Topics: Acanthosis Nigricans; Adrenergic alpha-Antagonists; Angiotensin-Converting Enzyme Inhibitors; Arteri	1993

Article	Year
Olmesartan/amlodipine/hydrochlorothiazide in obese participants with hypertension: a TRINITY subanalysis. Journal of clinical hypertension (Greenwich, Conn.), 2013, Volume: 15, Issue:8 Topics: Adult; Aged; Amlodipine; Antihypertensive Agents; Blood Pressure; Body Mass Index; Double-Blind Meth	2013
Efficacy and tolerability of triple-combination therapy with olmesartan, amlodipine, and hydrochlorothiazide: a subgroup analysis of patients stratified by hypertension severity, age, sex, and obesity. Journal of clinical hypertension (Greenwich, Conn.), 2014, Volume: 16, Issue:10 Topics: Adult; Age Factors; Aged; Amlodipine; Blood Pressure; Body Mass Index; Dose-Response Relationship, D	2014
Aliskiren-based therapy lowers blood pressure more effectively than hydrochlorothiazide-based therapy in obese patients with hypertension: sub-analysis of a 52-week, randomized, double-blind trial. Journal of hypertension, 2009, Volume: 27, Issue:7 Topics: Amides; Antihypertensive Agents; Double-Blind Method; Fumarates; Humans; Hydrochlorothiazide; Hypert	2009
Angiotensin receptor blocker/diuretic combination preserves insulin responses in obese hypertensives. Journal of hypertension, 2010, Volume: 28, Issue:8 Topics: Aged; Amlodipine; Angiotensin II Type 1 Receptor Blockers; Blood Glucose; Blood Pressure; Body Mass	2010
Efficacy and safety of irbesartan/HCTZ in severe hypertension according to cardiometabolic factors. Journal of clinical hypertension (Greenwich, Conn.), 2010, Jul-01, Volume: 12, Issue:7 Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl Compounds; Body Mas	2010
A comparison of the efficacy and safety of irbesartan/hydrochlorothiazide combination therapy with irbesartan monotherapy in the treatment of moderate or severe hypertension in diabetic and obese hypertensive patients: a post-hoc analysis review. Postgraduate medicine, 2011, Volume: 123, Issue:4 Topics: Antihypertensive Agents; Biphenyl Compounds; Diabetes Complications; Diabetes Mellitus, Type 2; Doub	2011
Office and ambulatory blood pressure-lowering effects of combination valsartan/hydrochlorothiazide vs. hydrochlorothiazide-based therapy in obese, hypertensive patients. Journal of clinical hypertension (Greenwich, Conn.), 2011, Volume: 13, Issue:10 Topics: Aged; Amlodipine; Antihypertensive Agents; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Co	2011
Efficacy of amlodipine/olmesartan medoxomil ± HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Current medical research and opinion, 2012, Volume: 28, Issue:11 Topics: Adult; Aged; Amlodipine; Antihypertensive Agents; Drug Therapy, Combination; Female; Humans; Hydroch	2012
Effects of body size and hypertension treatments on cardiovascular event rates: subanalysis of the ACCOMPLISH randomised controlled trial. Lancet (London, England), 2013, Feb-16, Volume: 381, Issue:9866 Topics: Aged; Amlodipine; Antihypertensive Agents; Benzazepines; Body Mass Index; Body Size; Body Weight; Ca	2013
Differential effects of renin-angiotensin-aldosterone system inhibition, sympathoinhibition and diuretic therapy on endothelial function and blood pressure in obesity-related hypertension: a double-blind, placebo-controlled cross-over trial. Journal of hypertension, 2013, Volume: 31, Issue:2 Topics: Cross-Over Studies; Diuretics; Double-Blind Method; Endothelium, Vascular; Female; Humans; Hydrochlo	2013
Comparative effects of candesartan and hydrochlorothiazide on blood pressure, insulin sensitivity, and sympathetic drive in obese hypertensive individuals: results of the CROSS study. Journal of hypertension, 2003, Volume: 21, Issue:9 Topics: Adolescent; Adult; Aged; Antihypertensive Agents; Benzimidazoles; Biphenyl Compounds; Blood Glucose;	2003
Efficacy and tolerability of combination therapy with valsartan plus hydrochlorothiazide compared with amlodipine monotherapy in hypertensive patients with other cardiovascular risk factors: the VAST study. Clinical therapeutics, 2005, Volume: 27, Issue:5 Topics: Age Factors; Aged; Amlodipine; Antihypertensive Agents; Blood Pressure; Cerebrovascular Disorders; D	2005
Hemodynamic and metabolic responses to valsartan and atenolol in obese hypertensive patients. Journal of hypertension, 2005, Volume: 23, Issue:12 Topics: Adrenergic beta-Antagonists; Adult; Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive	2005
[Arterial hypertension in obese patients. Rationale for a prospective medical care study in the family doctor's practice]. MMW Fortschritte der Medizin, 2004, Aug-05, Volume: 146 Suppl 2 Topics: Albuminuria; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl Compounds; C	2004
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension (Dallas, Tex. : 1979), 2007, Volume: 49, Issue:5 Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds;	2007
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension (Dallas, Tex. : 1979), 2007, Volume: 49, Issue:5 Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds;	2007
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension (Dallas, Tex. : 1979), 2007, Volume: 49, Issue:5 Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds;	2007
Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension (Dallas, Tex. : 1979), 2007, Volume: 49, Issue:5 Topics: Administration, Oral; Adult; Aged; Amides; Amlodipine; Antihypertensive Agents; Biphenyl Compounds;	2007
Optimal treatment of obesity-related hypertension: the Hypertension-Obesity-Sibutramine (HOS) study. Circulation, 2007, Apr-17, Volume: 115, Issue:15 Topics: Adult; Aged; Antihypertensive Agents; Appetite Depressants; Blood Pressure; Body Weight; Cyclobutane	2007
Telmisartan/hydrochlorothiazide versus valsartan/hydrochlorothiazide in obese hypertensive patients with type 2 diabetes: the SMOOTH study. Cardiovascular diabetology, 2007, Oct-02, Volume: 6 Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Benzimidazoles; Benzoates; Blood Pressure; Blood Pres	2007
The efficacy and safety of initial use of irbesartan/hydrochlorothiazide fixed-dose combination in hypertensive patients with and without high cardiovascular risk. Journal of clinical hypertension (Greenwich, Conn.), 2007, Volume: 9, Issue:12 Suppl 5 Topics: Aged; Aged, 80 and over; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl	2007
Effect of delapril/manidipine vs olmesartan/ hydrochlorothiazide combination on insulin sensitivity and fibrinogen in obese hypertensive patients. Internal medicine (Tokyo, Japan), 2008, Volume: 47, Issue:5 Topics: Adult; Angiotensin II Type 1 Receptor Blockers; Angiotensin-Converting Enzyme Inhibitors; Antihypert	2008
A double-blind, randomized study evaluating losartan potassium monotherapy or in combination with hydrochlorothiazide versus placebo in obese patients with hypertension. Current medical research and opinion, 2008, Volume: 24, Issue:4 Topics: Adult; Aged; Antihypertensive Agents; Blood Pressure; Double-Blind Method; Drug Therapy, Combination	2008
Blood pressure and cardiorenal responses to antihypertensive therapy in obese women. Arquivos brasileiros de endocrinologia e metabologia, 2008, Volume: 52, Issue:1 Topics: Adult; Amlodipine; Analysis of Variance; Antihypertensive Agents; Blood Pressure; Blood Pressure Mon	2008
Indapamide in the stepped-care treatment of obese hypertensive patients. Current medical research and opinion, 1983, Volume: 8 Suppl 3 Topics: Adult; Aged; Diuretics; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans;	1983
Comparison of the hemodynamic and metabolic effects of low-dose hydrochlorothiazide and lisinopril treatment in obese patients with high blood pressure. American journal of hypertension, 1995, Volume: 8, Issue:5 Pt 1 Topics: Administration, Oral; Blood Glucose; Drug Therapy, Combination; Female; Hemodynamics; Humans; Hydroc	1995
Glucose and insulin levels during diuretic therapy in hypertensive men. Hypertension (Dallas, Tex. : 1979), 1994, Volume: 23, Issue:6 Pt 1 Topics: Adult; Aged; Blood Glucose; Chlorthalidone; Diuretics; Electrolytes; Humans; Hydrochlorothiazide; Hy	1994
Lisinopril versus hydrochlorothiazide in obese hypertensive patients: a multicenter placebo-controlled trial. Treatment in Obese Patients With Hypertension (TROPHY) Study Group. Hypertension (Dallas, Tex. : 1979), 1997, Volume: 30, Issue:1 Pt 1 Topics: Adult; Aged; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Blood Pressure Monit	1997
Nocturnal reduction of blood pressure and the antihypertensive response to a diuretic or angiotensin converting enzyme inhibitor in obese hypertensive patients. TROPHY Study Group. American journal of hypertension, 1998, Volume: 11, Issue:8 Pt 1 Topics: Adult; Aged; Angiotensin-Converting Enzyme Inhibitors; Blood Pressure; Blood Pressure Monitoring, Am	1998

Article	Year
PATHOGENETIC ADVANCES OF FOSINOPRIL SODIUM WITH HYDROCHLOROTHIAZIDE IN OBESE HYPERTENSIVE PATIENTS. Georgian medical news, 2017, Issue:271 Topics: Adult; Aged; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents; Case-Control Studies	2017
Obesity and hypertension: It's about more than the numbers. Obesity (Silver Spring, Md.), 2013, Volume: 21, Issue:4 Topics: Antihypertensive Agents; Chlorthalidone; Diabetes Mellitus, Type 2; Dose-Response Relationship, Drug	2013
The Thiazide-Sensitive Co-Transporter Promotes the Development of Sodium Retention in Mice with Diet-Induced Obesity. Kidney & blood pressure research, 2015, Volume: 40, Issue:5 Topics: Animals; Dietary Fats; Hydrochlorothiazide; Mice; Mice, Inbred C57BL; Obesity; Receptors, Drug; Sodi	2015
Effects of diuretics on sodium-dependent glucose cotransporter 2 inhibitor-induced changes in blood pressure in obese rats suffering from the metabolic syndrome. Journal of hypertension, 2016, Volume: 34, Issue:5 Topics: Administration, Oral; Animals; Blood Pressure; Diuretics; Furosemide; Hydrochlorothiazide; Hypertens	2016
Preventing increased blood pressure in the obese Zucker rat improves severity of stroke. American journal of physiology. Heart and circulatory physiology, 2010, Volume: 299, Issue:1 Topics: Animals; Antihypertensive Agents; Blood Pressure; Blood Pressure Monitoring, Ambulatory; Diet, Sodiu	2010
Determinants of masked hypertension in hypertensive patients treated in a primary care setting. Internal medicine journal, 2012, Volume: 42, Issue:3 Topics: Adrenergic beta-Antagonists; Aged; Angiotensin-Converting Enzyme Inhibitors; Antihypertensive Agents	2012
Enhanced phosphorylation of Na(+)-Cl- co-transporter in experimental metabolic syndrome: role of insulin. Clinical science (London, England : 1979), 2012, Volume: 123, Issue:11 Topics: Animals; Blood Pressure; Cells, Cultured; Chromones; HEK293 Cells; Humans; Hydrochlorothiazide; Hype	2012
Sympathetic activation and endothelial dysfunction as therapeutic targets in obesity-related hypertension. Journal of hypertension, 2013, Volume: 31, Issue:2 Topics: Diuretics; Endothelium, Vascular; Female; Humans; Hydrochlorothiazide; Hypertension; Male; Obesity;	2013
[Hydrochlorothiazide and obesity]. El Dia medico, 1961, Apr-17, Volume: 33 Topics: Chlorothiazide; Hydrochlorothiazide; Obesity	1961
[Clinical experiences with thiabutazide (isobutylhydrochlorothiazide)]. Die Medizinische Welt, 1961, Jul-08, Volume: 27 Topics: Chlorothiazide; Edema; Hydrochlorothiazide; Obesity	1961
[GUSTATORY ACUITY FOR SALTY FLAVOR AND SALIVARY ELECTROLYTE CONCENTRATION]. Rassegna di neurologia vegetativa, 1963, Feb-28, Volume: 17 Topics: Addison Disease; Cerebrovascular Disorders; Chlorides; Cushing Syndrome; Flavoring Agents; Heart Fai	1963
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Hydrochlorothiazide with potassium in resistant exogenous obesities. Clinical medicine (Northfield, Ill.), 1961, Volume: 8 Topics: Humans; Hydrochlorothiazide; Nutrition Therapy; Obesity; Potassium	1961
[Good blood pressure control even in overweight patients]. MMW Fortschritte der Medizin, 2005, May-26, Volume: 147, Issue:21 Topics: Aged; Angiotensin II Type 1 Receptor Blockers; Antihypertensive Agents; Biphenyl Compounds; Blood Pr	2005
Dissolution of calcium oxalate renal stones in patient with jejunoileal bypass and after reanastomosis. Urology, 1982, Volume: 19, Issue:1 Topics: Adult; Calcium Oxalate; Female; Fluid Therapy; Humans; Hydrochlorothiazide; Ileum; Jejunum; Kidney C	1982
Essential hypertension in childhood. Pediatric annals, 1982, Volume: 11, Issue:7 Topics: Adolescent; Child; Diet, Sodium-Restricted; Electrocardiography; Humans; Hydrochlorothiazide; Hypert	1982
Fenfluramine potentiation of antihypertensive effects of thiazides. Clinical pharmacology and therapeutics, 1980, Volume: 28, Issue:1 Topics: Antihypertensive Agents; Blood Pressure; Body Weight; Drug Synergism; Drug Therapy, Combination; Fen	1980
[Effect of verospiron and hypothiazide on the indices of electrolyte metabolism in neuroendocrinological obesity]. Vrachebnoe delo, 1980, Issue:11 Topics: Adolescent; Adult; Diuretics; Female; Humans; Hydrochlorothiazide; Middle Aged; Mineralocorticoid Re	1980
[Lowering blood pressure in an obese patient with long-term hypertension. Using a fixed combination of enalapril/hydrochlorothiazide]. Fortschritte der Medizin, 1995, May-20, Volume: 113, Issue:14 Topics: Drug Combinations; Enalapril; Follow-Up Studies; Humans; Hydrochlorothiazide; Hypertension; Male; Mi	1995
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Perindopril ameliorates glomerular and renal tubulointerstitial injury in the SHR/N-corpulent rat. Hypertension (Dallas, Tex. : 1979), 1997, Volume: 30, Issue:5 Topics: Angiotensin-Converting Enzyme Inhibitors; Animals; Antihypertensive Agents; Diabetes Mellitus, Type	1997
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The lazy respiratory center--or how to recognize a tired horse. Clinical conference in pulmonary disease from Northwestern University-McGaw Medical Center, Chicago. Chest, 1974, Volume: 66, Issue:1 Topics: Brain Diseases; Chemoreceptor Cells; Chronic Disease; Diagnosis, Differential; Diazepam; Digoxin; Fu	1974
[Effect of 1-beta-oxyethyl-2-phenyl-methyl-piperidine in 6 cases of diabetes insipidus in children]. Archives francaises de pediatrie, 1968, Volume: 25, Issue:2 Topics: Biopsy; Body Temperature; Body Weight; Brain Diseases; Calcium; Child; Child, Preschool; Chlorides;	1968
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