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Generated: December 10, 2018

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CLINICAL TRIALS PROFILE FOR LOTREL

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Clinical Trials for Lotrel

Trial ID Title Status Sponsor Phase Summary
NCT00234871 Tarka® vs. Lotrel® in Hypertensive, Diabetic Subjects With Renal Disease (TANDEM) Completed Abbott Phase 4 The primary objective of this study is to determine if trandolapril/verapamil (Tarka®) is superior to amlodipine/benazepril (Lotrel®) in reduction of albuminuria in hypertensive subjects with Type 2 diabetes mellitus (DM) and diabetic nephropathy
NCT00649402 Fed Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan amlodipine and benazepril HCl 10 mg/20 mg to Novartis Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10 mg/20 mg) dose administered under fed conditions.
NCT00649519 Fasting Study of Amlodipine and Benazepril HCl Capsules 10 mg/20 mg to Lotrel® Capsules 10 mg/20 mg Completed Mylan Pharmaceuticals Phase 1 The objective of this study was to investigate the bioequivalence of Mylan's amlodipine and benazepril HCl 10 mg/20 mg to Novartis' Lotrel® 10 mg/20 mg combination capsules following a single, oral 10 mg/20 mg (1 x 10mg/20mg) dose administered under fasting conditions.
NCT00834977 Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fasting Conditions Completed Teva Pharmaceuticals USA Phase 1 The objective of this study is to compare the rate and extent of absorption of amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference), administered as 1 x 10 mg capsule under fasting conditions.
NCT00835367 Amlodipine-Benazepril 10mg-20mg Capsules in Healthy Subjects Under Fed Conditions Completed Teva Pharmaceuticals USA Phase 1 The objective of this study is to compare the rate and extent of absorption if amlodipine-benzazepril 10 mg-20 mg capsules (test) versus Lotrel® (reference),administered as 1 x 10 mg- 20 mg capsule under fed conditions.
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 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.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Lotrel

Condition Name

Condition Name for Lotrel
Intervention Trials
Healthy 5
Healhty 1
Fed 1
Fasting 1
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Condition MeSH

Condition MeSH for Lotrel
Intervention Trials
Proteinuria 1
Hypertension 1
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Clinical Trial Locations for Lotrel

Trials by Country

Trials by Country for Lotrel
Location Trials
Canada 2
United States 2
India 2
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Trials by US State

Trials by US State for Lotrel
Location Trials
West Virginia 2
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Clinical Trial Progress for Lotrel

Clinical Trial Phase

Clinical Trial Phase for Lotrel
Clinical Trial Phase Trials
Phase 4 1
Phase 1 8
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Clinical Trial Status

Clinical Trial Status for Lotrel
Clinical Trial Phase Trials
Completed 9
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Clinical Trial Sponsors for Lotrel

Sponsor Name

Sponsor Name for Lotrel
Sponsor Trials
Dr. Reddy's Laboratories Limited 4
Teva Pharmaceuticals USA 2
Mylan Pharmaceuticals 2
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Sponsor Type

Sponsor Type for Lotrel
Sponsor Trials
Industry 9
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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
McKesson
Mallinckrodt
Healthtrust
Cerilliant
Federal Trade Commission
AstraZeneca
Merck
Express Scripts

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