avapro and Chronic Kidney Failure

avapro has been researched along with Chronic Kidney Failure in 55 studies

Irbesartan: A spiro compound, biphenyl and tetrazole derivative that acts as an angiotensin II type 1 receptor antagonist. It is used in the management of HYPERTENSION, and in the treatment of kidney disease.
irbesartan : A biphenylyltetrazole that is an angiotensin II receptor antagonist used mainly for the treatment of hypertension.

Research

Studies (55)

Authors

Clinical Trials (15)

Trial Overview

Trial Outcomes

Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment

Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose. (NCT00923156)
Timeframe: Baseline, 12 weeks (Day 84 period 2)

Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment

Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose. (NCT00923156)
Timeframe: Baseline, 12 weeks (84 days, period 2)

Biomarker Urinary Aldosterone After 12 Weeks of Treatment

24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose. (NCT00923156)
Timeframe: Baseline,12 weeks (Day 84 period 2)

Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf)

Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. (NCT00923156)
Timeframe: 12 weeks

Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau)

Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. (NCT00923156)
Timeframe: 12 weeks

Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast)

Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. (NCT00923156)
Timeframe: 12 weeks

Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration

Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. (NCT00923156)
Timeframe: 12 weeks

Pharmacokinetic of Aliskiren: The Terminal Elimination Half-life (T½)

Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. (NCT00923156)
Timeframe: 12 weeks

Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration

Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. (NCT00923156)
Timeframe: 12 weeks

Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment

Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose. (NCT00923156)
Timeframe: Baseline,12 weeks (84 days, Period 2)

Venous Angiotensin II Levels After 12 Weeks of Treatment

Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose. (NCT00923156)
Timeframe: Baseline. 12 Weeks (Day 84, period 2)

All Cause Death

Number of patients - All-cause death. All-cause death is common in Heart Failure HF patients this measures how many patients had this event. (NCT00853658)
Timeframe: up to end of study (78 months)

Change From Baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score

Change from baseline to Month 12 for the Kansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score. KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. KCCQ clinical summary score is a composite assessment of physical limitations and total symptom scores. Scores are transformed to a range of 0-100, in which higher scores reflect better health status. (NCT00853658)
Timeframe: Baseline, Month 12

Number of Participants That Had First Occurrence of the Composite Endpoint, Which is Defined as Either Cardiovascular (CV) Death or Heart Failure (HF) Hospitalization

Number of participants that had first occurrence of the composite endpoint, which is defined as either CV death or HF hospitalization due to HF. (NCT00853658)
Timeframe: up to End of Study (78 months)

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at to End of Study

Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit. (NCT01151410)
Timeframe: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)

Change in Mean Arterial Pressure (MAP) (mmHg) From Baseline to End of Study

MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP--DBP). (NCT01151410)
Timeframe: Baseline to end of study (Week 52 or LOCF)

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study

Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 2 to 3 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit. (NCT01151410)
Timeframe: Baseline - end of study (Week 52 or Last observation carried forward (LOCF)

Percentage of Participants With Colonic Pathology

The primary analysis variable was the occurrence of an abnormal colonoscopy finding (defined as hyper-plastic polyps, inflammatory polyps, adenomatous polyps or carcinoma) at or prior to the planned one year visit. The occurrence of colonic pathology was identified during colonoscopy and histopathologic examination of biopsy. The composite endpoint was evaluated after one year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. (NCT00631917)
Timeframe: 54 weeks

Mucosal Hyperplasia Score in Rectal and Cecal Mucosal Biopsy Specimens After One Year of Treatment

Maximum hyperplasia score at end of study across rectal and cecal mucosa biopsy specimens. Score of 0 is no change from baseline, the minimum possible score. Score > 0 is worsening from baseline in which the maximum possible score is 3. (NCT00631917)
Timeframe: 54 weeks

Percentage of Participants Achieving the Mean Sitting Blood Pressure Control Target

The mean sitting blood pressure control target is defined as less than 140/90 mmHg (or 130/80 mmHg for diabetic patients) (NCT00631917)
Timeframe: Weeks 8, 30 and End of Study (54 weeks)

Percentage of Participants With Each of the Individual Components of Colonic Pathology

Assessment of the occurrence of the individual components (hyperplastic polyps, inflammatory polyps, adenomatous polyps or carcinomas) of the composite endpoint (colonic pathology) following one-year of treatment with an aliskiren-based regimen compared to a ramipril-based regimen. (NCT00631917)
Timeframe: 54 weeks

Summary of the End of Study Colonoscopy Results

During each colonoscopy procedure, random biopsy samples were taken from normal appearing mucosa in both the cecum and rectum in addition to obvious endoscopically atypical areas. The mucosal biopsy samples were evaluated for mucosal hyperplasia, dysplasia, and inflammation. Anything noted as a distinct visual abnormality from cecum to rectum such as ulcers, erythematous mucosa, or polyps, was photographed and biopsied for histopathology evaluation. Colonic lesions were categorized according to location in the colon, size, number, and morphology. (NCT00631917)
Timeframe: 54 weeks

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of variance included treatment factor and baseline value of mean sitting DBP as covariable. (NCT01042392)
Timeframe: Baseline to 8 weeks

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP as covariable. (NCT01042392)
Timeframe: Baseline to 8 weeks

Difference Between the Maximal and the Minimal Mean-hour SPB Measured Between 1 and 8 am at Week 8

Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the eve of visit 4 (week 8), the device attached to the ambulatory blood pressure non-dominant arm of the patient. The difference between mean-hour maximum SBP mean-hour minimum SBP between 1 am and 8 am was measured. (NCT01042392)
Timeframe: At week 8

Number of the Participants With More Than 55 mmHg Difference Between the Mean SBP Measured at the Morning Surge and the Mean Minimal SBP Measured During the Night

Ambulatory blood pressure measurement (ABPM) over 24 hours was performed for all patients on the day before visit 4, the device attached to the ambulatory blood pressure non-dominant arm of the patient. The BP morning surge was defined as the average of the measurements taken during the first 2 hours after waking the patient. The minimal night blood pressure was defined as the average of the two lowest BP measures (the lowest hourly average) recorded during night time. (NCT01042392)
Timeframe: After 8 weeks

Change in Mean Sitting DBP and SBP in Specified Sub-groups From Visit 2 (Baseline) to Visit 4 (at 8 Weeks)

"The sub-groups were: Riser = patients with >= 55 mmHg difference between the mean SPB measured at the morning surge and the mean minimal SBP measured during the night. The Non-risers in whom the difference is <55 mmHg. Patients called dippers in whom there was a decrease in average nocturnal SBP ≥ 10% compared with average daytime SBP, in contrast to patients non-dippers in whom this difference was <10%." (NCT01042392)
Timeframe: Baseline to 8 weeks

Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) From Last Active Dose Taken to After a One-day Missed-dose

The change in blood pressure was measured between visit 4 (end of the period of double-blind active treatment which was at week 8) and visit 5 (48 hours after the last active dose taken) in the group of patients who received aliskiren or placebo and those who received ramipril or placebo. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables. (NCT01042392)
Timeframe: From 8 weeks to 48 hours after week 8

Change in msSBP and msDBP From Visit 2 (Baseline) to Visit 3 (at 4 Weeks)

The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings. The analysis of covariance included treatment factor and baseline mean sitting SBP and mean sitting DBP as covariables. (NCT01042392)
Timeframe: Baseline to 4 weeks

Number Patients Reported With Adverse Events (AEs), Serious Adverse Events (SAE) and Death (Period II and Period III)

Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards. (NCT01042392)
Timeframe: 8 weeks + 1 day

Percentage of Patients With Controlled Blood Pressure

"The arm in which the highest sitting systolic blood pressure (SBP) was found at study entry was used for all subsequent readings. At each study visit, after leaving the patient to rest 5 minutes in a sitting position, the blood pressure (BP) was measured three times with an oscillometric device. The measurements were performed at 1-2 minute intervals. The mean BP was calculated from the 3 readings.~Controlled blood pressure (BP) is defined as mean office systolic BP/ diastolic BP < 140/90 mmHg." (NCT01042392)
Timeframe: At 4 and 8 weeks

Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12

(NCT00368277)
Timeframe: Baseline and Week 12

Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36

(NCT00368277)
Timeframe: Baseline and week 36

Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints

Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg (NCT00368277)
Timeframe: Weeks 12 and 36

Percentage of Patients With Cough

(NCT00368277)
Timeframe: Weeks 12 and 36

Evaluation of the Percentage of Patients Controlled to a Target Blood Pressure of < 140/90 mmHg on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg

To evaluate the percentage of patients controlled to a target blood pressure of < 140/90 mmHg on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg. (NCT00529451)
Timeframe: Week 8

Evaluation of the Percentage of Responders on Aliskiren 300 mg, 150 mg and 75 mg vs. Ramipril 5 mg, Define as msDBP < 90 mmHg or ≥ 10mmHg Decrease From Baseline in msDBP

To evaluate the percentage of responders on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg, defined as msDBP < 90 mmHg or ≥ 10mmHg decrease from baseline in msDBP. (NCT00529451)
Timeframe: Week 8

Non-inferiority of Aliskiren 150 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)

To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint (NCT00529451)
Timeframe: Baseline and Week 8

Non-inferiority of Aliskiren 300 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)

To evaluate the non-inferiority of aliskiren 300 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint (NCT00529451)
Timeframe: Baseline and Week 8

Non-inferiority of Aliskiren 75 mg to Ramipril 5 mg in Change in Mean Sitting Diastolic Blood Pressure (msDBP)

To evaluate the non-inferiority of aliskiren 75 mg to ramipril 5 mg in the change in Mean Sitting Diastolic Blood Pressure (msDBP) from baseline to 8 week endpoint (NCT00529451)
Timeframe: Baseline and Week 8

Change in Mean Sitting Systolic Blood Pressure (msSBP)and Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to 8 Week Endpoint

To evaluate the change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic blood Pressure (msDBP) from baseline to 8 week endpoint on aliskiren 300 mg, 150 mg and 75 mg vs. ramipril 5 mg in patients with essential hypertension. (NCT00529451)
Timeframe: Baseline and Week 8

Reviews

17 reviews available for avapro and Chronic Kidney Failure

Trials

12 trials available for avapro and Chronic Kidney Failure

Other Studies

27 other studies available for avapro and Chronic Kidney Failure