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Hypertension and Cardiovascular Risk Factors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171782
First Posted: September 15, 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
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.

Condition Intervention Phase
HYPERTENSION Drug: VALSARTAN+HYDROCHLOROTHIAZIDE Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

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

Enrollment: 76
Study Start Date: February 2004
Study Completion Date: December 2004
Primary Completion Date: December 2004 (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 to 80 Years   (Adult, Senior)
Criteria

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.

  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): NCT00171782


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00171782     History of Changes
Other Study ID Numbers: CVAH631BCO02
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: November 8, 2011
Last Verified: June 2006

Keywords provided by Novartis:
HYPERTENSION
VALSARTAN
VALSARTAN AND HYDROCHLOROTHIAZIDE
RISK FACTORS

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