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Last Updated: May 16, 2021

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CLINICAL TRIALS PROFILE FOR AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE

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All Clinical Trials for Amlodipine Besylate; Benazepril Hydrochloride

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00136851 Study Comparing the Efficacy of Amlodipine Besylate/Benazepril Versus Amlodipine in the Treatment of Severe Hypertension Completed Novartis Pharmaceuticals Phase 4 2004-12-01 This trial is designed to study the efficacy of an amlodipine besylate/benazepril treatment regimen versus an amlodipine treatment regimen in the treatment of severe hypertension.
NCT01155895 Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2004-03-01 The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under fasting conditions.
NCT01155908 Bioequivalence Study of 10 mg Amlodipine Besylate/ 20 mg Benazepril Hydrochloride Capsules of Dr.Reddys Laboratories Limited Under Non-fasting (Fed) Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2005-04-01 The objective of this study was to compare the single-dose relative bioavailability of Dr. Reddy's Laboratories, Ltd. and Lotrel®) 10 mg amlodipine besylate/20 mg benazepril hydrochloride capsules, under non-fasting (fed) conditions.
NCT01505998 Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fed Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2007-03-01 The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fed conditions.
NCT01506011 Bioequivalence Study of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg Capsules of Dr. Reddy's Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 2007-03-01 The purpose of this study single dose bioequivalence of Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules with Lotrel® capsules in healthy human subjects and monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance under fasting conditions
NCT03682692 ACEI/CCB Versus ACEI/DIU Combination Antihypertensive Therapy in Chinese Hypertensive Patients (ACvAD) Recruiting Shanghai Jiao Tong University School of Medicine Phase 4 2018-06-01 1. Study name: ACEI/CCB versus ACEI/DIU combination antihypertensive therapy in Chinese hypertensive patients (ACvAD) 2. Medicine: Benazepril 10 mg / amlodipine besylate 5 mg fixed-dose combination, benazepril 10 mg / hydrochlorothiazide 12.5 mg fixed-dose combination. 3. Rationale:Most current hypertension guidelines, including the Chinese guidelines for the management of hypertension, recommend the combination therapy of an angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) with a calcium antagonists (CCB) or thiazide diuretics (DIU). However, whether the two combination treatments have similar antihypertensive effects in Chinese hypertensive patients is still lack of clinical evidence, especially randomized controlled trials using ambulatory or home blood pressure measurement as the main evaluation method. 4. Objective: To evaluate the reduction of 24-hour ambulatory systolic blood pressure in the ACEI/CCB group compared with the ACEI/DIU group after 6 months of antihypertensive treatment. 5. Study design: This study is a multi-center, randomized and controlled clinical trial with two equally sized treatment groups: ACEI/CCB group and ACEI/DIU group. 6. Study population: Men or women over 18 years (n=580) meeting the inclusion/exclusion criteria. 7. Randomization and treatment: Potentially eligible patients should receive a 24-hour ambulatory blood pressure monitoring measurement before randomization. After stratification by centers and whether receive antihypertensive treatment, eligible patients will be randomly divided into two groups, taking benazepril 10 mg/amlodipine besylate 5mg fixed-dose combination (1 tablet once a day) or benazepril 10 mg/hydrochlorothiazide 12.5 mg fixed-dose combination (1 tablet once a day). 8. Follow up: All patients should sign an informed consent form before entering the study. The follow-up period is 6 months. 9. Sample size estimation: a total of 580 patients should be enrolled in this study. 10. Timeline: Ethical review: November 2017; Enrollment: January 2018-June 2020; End of follow-up: December 2020. 11. Organization: The Centre for Epidemiological Studies and Clinical Trials, Ruijin Hospital, Shanghai, China.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Amlodipine Besylate; Benazepril Hydrochloride

Condition Name

Condition Name for Amlodipine Besylate; Benazepril Hydrochloride
Intervention Trials
Hypertension 2
Healthy 2
Fed 1
Fasting 1
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Condition MeSH

Condition MeSH for Amlodipine Besylate; Benazepril Hydrochloride
Intervention Trials
Hypertension 2
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Clinical Trial Locations for Amlodipine Besylate; Benazepril Hydrochloride

Trials by Country

Trials by Country for Amlodipine Besylate; Benazepril Hydrochloride
Location Trials
India 2
China 1
United States 1
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Trials by US State

Trials by US State for Amlodipine Besylate; Benazepril Hydrochloride
Location Trials
New Jersey 1
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Clinical Trial Progress for Amlodipine Besylate; Benazepril Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Amlodipine Besylate; Benazepril Hydrochloride
Clinical Trial Phase Trials
Phase 4 2
Phase 1 4
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Clinical Trial Status

Clinical Trial Status for Amlodipine Besylate; Benazepril Hydrochloride
Clinical Trial Phase Trials
Completed 5
Recruiting 1
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Clinical Trial Sponsors for Amlodipine Besylate; Benazepril Hydrochloride

Sponsor Name

Sponsor Name for Amlodipine Besylate; Benazepril Hydrochloride
Sponsor Trials
Dr. Reddy's Laboratories Limited 4
Shanghai Jiao Tong University School of Medicine 1
Novartis Pharmaceuticals 1
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Sponsor Type

Sponsor Type for Amlodipine Besylate; Benazepril Hydrochloride
Sponsor Trials
Industry 5
Other 1
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