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OpenTrials
Completed

NCT Number: NCT00241007

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

SAFETY EXTENSION STUDY TO THE CORE STUDY CVAH631C2301

Completed

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

SUCCESSFUL COMPLETION OF STUDY CVAH631C2301

-

Exclusion criteria

  • NONE

Treatment and study plan

VALSARTAN, VALSARTAN+HYDROCHLOROTHIAZIDE

Drug

Primary outcomes

  1. Adverse events and serious adverse events at each study visit for 54 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Oct 18, 2005
Registry last updated
Nov 8, 2011

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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