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) | Active, not 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. Rationale:Most current hypertension guidelines 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. 3. 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. 4. Study population: Men or women over 18 years (n=580) meeting the inclusion/exclusion criteria. 5. 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). 6. Follow up: All patients should sign an informed consent form before entering the study. The follow-up period is 6 months. 7. Sample size estimation: a total of 580 patients should be enrolled in this study. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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