Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension - Full Text View

Sponsor:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00425373

Purpose

The purpose of this study is to evaluate the safety and efficacy of fixed combination of valsartan (40 mg and 80 mg) and amlodipine (2.5 mg and 5 mg), valsartan and amlodipine alone, and placebo in reducing blood pressure. The study will investigate the dose response relationship for the combinations, monotherapies and placebo.

Condition	Intervention	Phase
Essential Hypertension	Drug: Valsartan + Amlodipine besilate	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Factorial Study to Evaluate the Efficacy and Safety of 8-Week Treatment With VAA489 [Valsartan (40 and 80 mg) and Amlodipine (2.5 and 5 mg) Combined] and Alone in Essential Hypertensive Patients - Double-Blind Study of VAA489 in Patients With Essential Hypertension (Factorial Study)

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Amlodipine Amlodipine besylate Valsartan Exforge

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Change from baseline in mean sitting diastolic blood pressure at 8 weeks.

Secondary Outcome Measures:

Change from baseline in mean sitting systolic blood pressure (MSSBP) at trough at 8 weeks.
Responder rate for achieving MSDBP < 90 mmHg or a ≥ 10 mmHg decrease compared to baseline.
Diastolic control rate for achieving MSDBP < 90mmHg.
Blood pressure control rate for achieving MSDBP <90 mmHg and MSSBP <140 mmHg.

Estimated Enrollment:	1404
Study Start Date:	November 2006
Study Completion Date:	May 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Essential hypertension
Outpatients

Exclusion Criteria:

Secondary hypertension or suspected of having secondary hypertension.
A history of malignant hypertension
Severe hypertension
Significant heart, renal, hepatic diseases or significant cerebrovascular disorder

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00425373

Locations

Japan
Novartis Pharmaceuticals
Tokyo, Japan, 11111

Sponsors and Collaborators

Novartis

Investigators

Study Chair:

Novartis Japan

Sponsor GmbH

More Information

No publications provided

Study ID Numbers:	CVAA489A1301
Study First Received:	January 22, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00425373 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Novartis:

Hypertension, Valsartan, Amlodipine, high blood pressure

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Vascular Diseases
Calcium Channel Blockers
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions

Amlodipine
Membrane Transport Modulators
Therapeutic Uses
Cardiovascular Diseases
Valsartan
Hypertension

ClinicalTrials.gov processed this record on November 05, 2009