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

Tracking Information

First Received Date ^ICMJE

January 22, 2007

Last Updated Date

June 9, 2008

Start Date ^ICMJE

November 2006

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00425373 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Efficacy and Safety of Valsartan and Amlodipine in Patients With Essential Hypertension

Official Title ^ICMJE

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)

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Factorial Assignment, Safety/Efficacy Study

Condition ^ICMJE

Essential Hypertension

Intervention ^ICMJE

Drug: Valsartan + Amlodipine besilate

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

1404

Completion Date

May 2008

Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT ID ^ICMJE

NCT00425373

Responsible Party

Study ID Numbers ^ICMJE

CVAA489A1301

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Novartis Japan

Sponsor GmbH

Information Provided By

Novartis

Verification Date

June 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP