CLINICAL TRIALS PROFILE FOR BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
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All Clinical Trials for benazepril hydrochloride; hydrochlorothiazide
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00170950 ↗ | Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension | Terminated | Novartis | Phase 3 | 2003-10-01 | A comparison study of two combination drugs, amlodipine/benazepril and benazepril/HCTZ to evaluate the effectiveness of the combination on reducing heart disease and death in a high risk hypertensive population. |
| NCT00367094 ↗ | Combination of Benazepril Plus Hydrochlorothiazide in Chinese Patients With Mild to Moderate Essential Hypertension | Completed | Novartis | Phase 3 | 2006-07-01 | This study will evaluate efficacy and safety data for benazepril/hydrochlorothiazide in adult Chinese patients with mild to moderate essential hypertension. Patients whose blood pressure is not adequately controlled with benazepril monotherapy during a 4 week run-in period will be randomly allocated to double blind treatment over 8 weeks with either a combination of benazepril/hydrochlorothiazide per day or continuation of benazepril per day. |
| NCT00649038 ↗ | Fed Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg | Completed | Mylan Pharmaceuticals | Phase 1 | 2002-12-01 | The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fed conditions. |
| NCT00649597 ↗ | Fasting Study of Benazepril HCl and Hydrochlorothiazide Tablets 20 mg/25 mg to Lotensin HCT® Tablets 20 mg/25 mg | Completed | Mylan Pharmaceuticals | Phase 1 | 2002-11-01 | The objective of this study was to investigate the bioequivalence of Mylan benazepril HCl and hydrochlorothiazide 20 mg/25 mg to Novartis Lotensin HCT® 20 mg/25 mg combination tablets following a single, oral 40 mg/50 mg (2 x 20 mg/25 mg) dose administration under fasting conditions. |
| NCT00778674 ↗ | Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fed Conditions | Completed | Ranbaxy Laboratories Limited | N/A | 2004-10-01 | The purpose of this study was to determine the bioavailability of Benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy subjects under fed conditions. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria. |
| NCT00778726 ↗ | Bioequivalence Study of Benazepril HCl / Hydrochlorothiazide 20 mg/ 25 mg Tablets Under Fasting Conditions | Completed | Ranbaxy Laboratories Limited | N/A | 2004-09-01 | The purpose of this study was to determine the bioavailability of benazepril and hydrochlorothiazide (HCTZ) from two Benazepril/HCTZ 20 mg/25 mg products after administration of single doses to normal healthy fasted subjects. These data were to be evaluated statistically to determine if the products meet bioequivalence criteria. |
| NCT01375322 ↗ | ADDM Study - Amtrel and Co-Diovan in Type 2 Diabetes Mellitus Hypertension Patients With Microalbuminuria | Completed | TSH Biopharm Corporation Limited | Phase 4 | 2007-06-01 | The purpose of the study is to compare the change from baseline in blood pressures (DBP/SBP) to 16-week regimen between Amtrel® and Co-Diovan®. The secondary objectives were listed as the following. - To compare the response rate (defined as SBP < 130 mmHg and DBP < 80 mmHg) at the end of study - To evaluate the change from baseline in albumin-to-creatinine ratio with antihypertensive medications in whole group (combined treatment groups) and each treatment group (Amtrel®, Co-Diovan®) at Week 16 - The change from baseline in glycosylated hemoglobin (HbA1c) at Week 16 - The change from baseline in fasting plasma glucose (FPG) at Week 16 - The change from baseline in fasting lipid profiles (triglyceride, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol) at Week 16 - The change from baseline in arteriosclerosis marker (brachial-ankle pulse-wave velocity (ba-PWV) and ankle-brachial pressure index (ABI), using Colin-VP1000) at Week 16 - The change from baseline on the body mass index (BMI) and waist-hip ratio (WHR) at each specified study time point - To ascertain the safety and tolerability of Amtrel® versus Co-Diovan® including AE/SAE, and laboratory examinations |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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