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

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ClinicalTrials.gov Identifier: NCT00311740
Recruitment Status : Completed
First Posted : April 6, 2006
Last Update Posted : February 23, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis

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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Valsartan Drug: Hydrochlorothiazide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 582 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2006
Actual Primary Completion Date : September 2006
Actual Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Change from baseline in diastolic blood pressure after 8 weeks

Secondary Outcome Measures :
  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


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311740


Locations
Japan
Novartis Pharmaceuticals
Tokyo, Japan
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novatis Pharmaceuticals

Additional Information:
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00311740     History of Changes
Other Study ID Numbers: CVAH631B1303
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Novartis:
Hypertension,
Valsartan,
Hydrochlorothiazide

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Valsartan
Hydrochlorothiazide
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators