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| Sponsor: | Novartis |
|---|---|
| Information provided by: | Novartis |
| ClinicalTrials.gov Identifier: | NCT00413049 |
Purpose
This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Valsartan/amlodipine 80/5 mg Drug: Amlodipine 5 mg |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-national, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 80/5 mg to Amlodipine 5 mg Alone Once Daily in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Amlodipine 5 mg Monotherapy |
| Enrollment: | 698 |
| Study Start Date: | January 2007 |
| Study Completion Date: | November 2007 |
| Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Valsartan/amlodipine 80/5 mg |
Drug: Valsartan/amlodipine 80/5 mg
1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
|
| Active Comparator: Amlodipine 5 mg |
Drug: Amlodipine 5 mg
1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria
Exclusion criteria
Contacts and Locations| China | |
| China-Japan Friendship Hospital | |
| Beijing, China, 100029 | |
| People's hospital affiliated Beijing University | |
| Beijing, China, 100044 | |
| The third Xiangya hospital of central south University | |
| Changsha, China, 410003 | |
| The first hospital affiliated the third military Medical University | |
| Chongqing, China, 400038 | |
| The third hospital affiliated the third military Medical University | |
| Chongqing, China, 400042 | |
| The first hospital affiliated Fujian medical University | |
| Fuzhou, China, 350005 | |
| Union hospital affiliated Fujian medical University | |
| Fuzhou, China, 350001 | |
| The second hospital affiliated Jiangxi medical school | |
| Nanchang, China, 330006 | |
| Zhongshan hospital affiliated Fudan University | |
| Shanghai, China, 200032 | |
| The sixth people's hospital of Shanghai | |
| Shanghai, China, 200233 | |
| Institute of Hypertension, Ruijin Hospital | |
| Shanghai, China, 200025 | |
| The first hospital affiliated school of medical of Xi'an Jiaotong University | |
| Xi'an, China, 710061 | |
| Study Director: | Novartis Pharmaceuticals | Sponsor GmbH |
More Information
| Responsible Party: | Novartis Medical Director, Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00413049 History of Changes |
| Other Study ID Numbers: | CVAA489A2315 |
| Study First Received: | December 18, 2006 |
| Results First Received: | January 11, 2011 |
| Last Updated: | April 26, 2011 |
| Health Authority: | China: State Food and Drug Administration; United States: Food and Drug Administration |
|
Hypertension, valsartan, amlodipine, high blood pressure |
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Valsartan Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |