A Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

February 21, 2017 updated by: Novartis

A Multi-center, Factorial Study to Evaluate Efficacy & Safety of 8 Wks Treatment With VAH631 [Valsartan (40 & 80 mg) and Hydrochlorothiazide (6.25 & 12.5 mg) Combined & Alone in Essential Hypertensive Patients] - Double-blind Study of VAH631 in Patients With Essential Hypertension (Factorial Study)

The purpose of this study is to compare the effect of the fixed combination of valsartan+hydrochlorothiazide (HCTZ) on blood pressure reduction with valsartan and HCTZ alone and whether the combination treatments are safe and well tolerated. The study aims to establish a dose response relationship for both monotherapies and the combinations.

This study is being conducted in Japan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

582

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tokyo, Japan
        • Novartis Pharmaceuticals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Essential hypertension measured by mercury sphygmomanometer
  • 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
  • Gout Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures

Outcome Measure
Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks
Change from baseline in systolic blood pressure after 8 weeks
Change from baseline in standing diastolic blood pressure after 8 weeks
Change from baseline in standing systolic blood pressure after 8 weeks
Adverse events and serious adverse events at each study visit for 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

April 4, 2006

First Submitted That Met QC Criteria

April 4, 2006

First Posted (Estimate)

April 6, 2006

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 21, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CVAH631B1303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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