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

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ClinicalTrials.gov Identifier: NCT00241007
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : November 8, 2011
Sponsor:
Information provided by (Responsible Party):
Novartis

Brief Summary:
SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301

Condition or disease Intervention/treatment Phase
Hypertension Drug: VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 836 participants
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
Study Start Date : December 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

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

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


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

Inclusion Criteria:

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

Exclusion Criteria:


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

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241007     History of Changes
Other Study ID Numbers: CVAH631C2301E1
First Posted: October 18, 2005    Key Record Dates
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