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A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241007
First Posted: October 18, 2005
Last Update Posted: November 8, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301

Condition Intervention Phase
Hypertension Drug: VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Adverse events and serious adverse events at each study visit for 54 weeks

Secondary Outcome Measures:
  • Change from baseline in diastolic blood pressure from baseline after 54 weeks
  • Change from baseline in systolic blood pressure from baseline after 54 weeks
  • Change from baseline in standing diastolic and systolic blood pressure after 54 weeks
  • Hematology and blood chemistries up to 54 weeks
  • Physical condition including pregnancy, pulse and weight at each study visit

Enrollment: 836
Study Start Date: December 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

Exclusion Criteria:

  Contacts and Locations
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): NCT00241007


Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241007     History of Changes
Other Study ID Numbers: CVAH631C2301E1
First Submitted: October 14, 2005
First Posted: October 18, 2005
Last Update Posted: November 8, 2011
Last Verified: October 2005

Keywords provided by Novartis:
HYPERTENSION, VALSARTAN

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