Hypertension and Cardiovascular Risk Factors

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. Identifier: NCT00171782
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : November 8, 2011
Information provided by (Responsible Party):

Brief Summary:
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.

Condition or disease Intervention/treatment Phase

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Valsartan Plus Hydrochlorothiazide in Patients With Hypertension and Cardiovascular Risk Factors
Study Start Date : February 2004
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Change from baseline systolic blood pressure at 8 weeks

Secondary Outcome Measures :
  1. Blood pressure less than 140/90 mmHg at 8 weeks
  2. Reduction from baseline in diastolic blood pressure greater than or equal to 10 mmHg
  3. Reduction from baseline in systolic blood pressure greater than or equal to 20 mmHg

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)

Inclusion Criteria:

  • - Patients who give consent
  • Men and women 18 to 80 years of age
  • Patients with hypertension (systolic >159 mm, diastolic >100 mm)
  • Patients meeting laboratory criteria

Exclusion Criteria:

  • - Pregnant women
  • Women not using approved contraception methods
  • Secondary hypertension

Other protocol-defined 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 identifier (NCT number): NCT00171782

Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Responsible Party: Novartis Identifier: NCT00171782     History of Changes
Other Study ID Numbers: CVAH631BCO02
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 8, 2011
Last Verified: June 2006

Keywords provided by Novartis:

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