CLINICAL TRIALS PROFILE FOR BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE

All Clinical Trials for Benazepril Hydrochloride And 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

Clinical Trial Conditions for Benazepril Hydrochloride And Hydrochlorothiazide

Condition Name

Condition Name for Benazepril Hydrochloride And Hydrochlorothiazide
Intervention	Trials
Healthy	4
Hypertension	4
Albuminuria	1
Diabetes Mellitus, Type 2	1

Condition MeSH

Condition MeSH for Benazepril Hydrochloride And Hydrochlorothiazide
Intervention	Trials
Hypertension	4
Diabetes Mellitus, Type 2	1
Diabetes Mellitus	1
Albuminuria	1

Clinical Trial Locations for Benazepril Hydrochloride And Hydrochlorothiazide

Trials by Country

Trials by Country for Benazepril Hydrochloride And Hydrochlorothiazide
Location	Trials
United States	5
China	2
Taiwan	1
Norway	1
Finland	1

Trials by US State

Trials by US State for Benazepril Hydrochloride And Hydrochlorothiazide
Location	Trials
North Carolina	2
North Dakota	2
New Jersey	1

Clinical Trial Progress for Benazepril Hydrochloride And Hydrochlorothiazide

Clinical Trial Phase

Clinical Trial Phase for Benazepril Hydrochloride And Hydrochlorothiazide
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	2
Phase 1	2

Clinical Trial Status

Clinical Trial Status for Benazepril Hydrochloride And Hydrochlorothiazide
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	1
Terminated	1

Clinical Trial Sponsors for Benazepril Hydrochloride And Hydrochlorothiazide

Sponsor Name

Sponsor Name for Benazepril Hydrochloride And Hydrochlorothiazide
Sponsor	Trials
Mylan Pharmaceuticals	2
Ranbaxy Laboratories Limited	2
Novartis	2

Sponsor Type

Sponsor Type for Benazepril Hydrochloride And Hydrochlorothiazide
Sponsor	Trials
Industry	7
Other	1