losartan and Alport Syndrome studies

Losartan: An antagonist of ANGIOTENSIN TYPE 1 RECEPTOR with antihypertensive activity due to the reduced pressor effect of ANGIOTENSIN II.
losartan : A biphenylyltetrazole where a 1,1'-biphenyl group is attached at the 5-position and has an additional trisubstituted imidazol-1-ylmethyl group at the 4'-position

Research Excerpts

Excerpt	Relevance	Reference
"A previous subgroup analysis of a 12-week, double-blind study demonstrated that losartan significantly lowered proteinuria versus placebo and amlodipine and was well tolerated in children (1-17 years old) with proteinuria secondary to Alport syndrome."	9.17	Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. ( Gleim, GW; Lam, C; Massaad, R; McCrary Sisk, C; Shahinfar, S; Webb, NJ; Wells, TG, 2013)
"Twelve weeks of treatment with losartan significantly reduced proteinuria compared with placebo/amlodipine: losartan -14."	9.15	Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. ( Gleim, GW; Lam, C; Le Bailly De Tilleghem, C; Shahinfar, S; Strehlau, J; Webb, NJ; Wells, TG, 2011)
"A previous subgroup analysis of a 12-week, double-blind study demonstrated that losartan significantly lowered proteinuria versus placebo and amlodipine and was well tolerated in children (1-17 years old) with proteinuria secondary to Alport syndrome."	5.17	Losartan and enalapril are comparable in reducing proteinuria in children with Alport syndrome. ( Gleim, GW; Lam, C; Massaad, R; McCrary Sisk, C; Shahinfar, S; Webb, NJ; Wells, TG, 2013)
"Twelve weeks of treatment with losartan significantly reduced proteinuria compared with placebo/amlodipine: losartan -14."	5.15	Efficacy and safety of losartan in children with Alport syndrome--results from a subgroup analysis of a prospective, randomized, placebo- or amlodipine-controlled trial. ( Gleim, GW; Lam, C; Le Bailly De Tilleghem, C; Shahinfar, S; Strehlau, J; Webb, NJ; Wells, TG, 2011)

Research

Studies (2)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Double-Blind Treatment Phase: Change From Baseline in Diastolic Blood Pressure in Hypertensive Participants at Week 12

Double-Blind Treatment Phase: Change From Baseline in Systolic Blood Pressure in Hypertensive Participants at Week 12

Double-Blind Treatment Phase: Percent Change From Baseline in Urinary Protein/Creatinine (Pr/Cr) Ratio (gm/gm) at Week 12

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	2 (100.00)	24.3611
2020's	0 (0.00)	2.80

Authors	Studies
Webb, NJ	2
Lam, C	2
Shahinfar, S	2
Strehlau, J	1
Wells, TG	2
Gleim, GW	2
Le Bailly De Tilleghem, C	1
Massaad, R	1
McCrary Sisk, C	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Randomized, Double-Blind, Parallel, Placebo or Amlodipine-Controlled Study of the Effects of Losartan on Proteinuria in Pediatric Patients With or Without Hypertension[NCT00568178]	Phase 3	306 participants (Actual)	Interventional	2007-06-01	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Intervention	mm Hg (Least Squares Mean)
Losartan-Hypertensive Participants	-3.8
Amlodipine-Hypertensive Participants	0.8

Intervention	mm Hg (Least Squares Mean)
Losartan-Hypertensive Participants	-5.5
Amlodipine-Hypertensive Participants	-0.1

"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately twelve weeks of treatment.~Baseline is defined as values obtained at Visit 3, Week (-1) during the Single Blind Run-in period." (NCT00568178)
Timeframe: Baseline and Week 12

Open Label Extension: Change From Baseline in Glomerular Filtration Rate (GFR) at Month 36

Intervention	Percent Change in Pr/Cr (Geometric Mean)
Losartan	-35.80
Amlodipine/Placebo	1.37

"The outcome measure of glomerular filtration rate was based on mL/min/1.73m^2, as determined by the Schwartz formula:~GFR = _____0.55 x height (cm)_______ divided by serum creatinine (mg/dL)~GFR values were compared to the baseline GFR measure.~[Note: For male participants, ages 13 to 17 years, 0.70 was used as~the multiplier in place of 0.55]~Baseline in regard to the extension is defined as the last value obtained in the double-blind treatment phase." (NCT00568178)
Timeframe: Baseline and Month 36

Open Label Extension: Percent Change From Baseline of Urinary Pr/Cr Ratio (gm/gm) at Month 36

Intervention	Change in GFR mL/min1.73m^2 (Least Squares Mean)
Losartan Open Label Extension	3.3
Enalapril Open Label Extension	7.0

"Change in urinary protein excretion, determined as urinary Pr/Cr ratio compared to baseline*, after approximately three years of treatment.~*The baseline for efficacy data in the extension was defined as the last value obtained in the double-blind treatment phase." (NCT00568178)
Timeframe: Baseline and Month 36

Intervention	Percent Change in Pr/Cr (Geometric Mean)
Losartan Open Label Extension	-30.01
Enalapril Open Label Extension	-40.45