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Completed

NCT Number: NCT00311740

A 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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

Tokyo, Japan

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan

Drug

Hydrochlorothiazide

Drug

Primary outcomes

  1. Change from baseline in diastolic blood pressure after 8 weeks

Secondary outcomes

  1. Change from baseline in systolic blood pressure after 8 weeks

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

  3. Change from baseline in standing diastolic blood pressure after 8 weeks

  4. Change from baseline in standing systolic blood pressure after 8 weeks

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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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)

Important dates

Study start
2006
Primary completion
2006
Study completion
2006
First posted
Apr 6, 2006
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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