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

Information source: Novartis
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Novartis

Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis

Summary

SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301

Clinical Details

Official title: A Study Comparing Valsartan With And Without Hydrochlorothiazide In Patients With Hypertension

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Adverse events and serious adverse events at each study visit for 54 weeks

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

-

Exclusion Criteria:

- NONE

Locations and Contacts

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Novartis Pharmaceuticals, East Hanover, New Jersey 07936, United States

Additional Information

Starting date: December 2003
Last updated: June 1, 2006

Page last updated: March 21, 2008

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