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

Primary Purpose

Hypertension

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Valsartan

Hydrochlorothiazide

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension,, Valsartan,, Hydrochlorothiazide

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

Novartis Pharmaceuticals

Outcomes

Primary Outcome Measures

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures

Change from baseline in systolic blood pressure after 8 weeks

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 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

Full Information

NCT ID

NCT00311740

First Posted

April 4, 2006

Last Updated

February 21, 2017

Sponsor

Novartis

1. Study Identification

Unique Protocol Identification Number

NCT00311740

Brief Title

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

Official Title

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

March 2006 (undefined)

Primary Completion Date

September 2006 (Actual)

Study Completion Date

September 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

Keywords

Hypertension,, Valsartan,, Hydrochlorothiazide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

Double

Allocation

Randomized

Enrollment

582 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Valsartan

Intervention Type

Drug

Intervention Name(s)

Hydrochlorothiazide

Primary Outcome Measure Information:

Title

Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measure Information:

Title

Change from baseline in systolic blood pressure after 8 weeks

Title

Diastolic blood pressure less than 90 mmHg or at least a 10 mmHg decrease in diastolic blood pressure after 8 weeks

Title

Change from baseline in standing diastolic blood pressure after 8 weeks

Title

Change from baseline in standing systolic blood pressure after 8 weeks

Title

Adverse events and serious adverse events at each study visit for 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novatis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Pharmaceuticals

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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