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Hypertension and Cardiovascular Risk Factors

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: September 13, 2005
Last updated: November 7, 2011
Last verified: June 2006
A study to evaluate the efficacy of valsartan+chydochlorothiazide in patients with stage 2 hypertension and cardiovascular risk factors.

Condition Intervention Phase
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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)

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

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
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Please refer to this study by its identifier: NCT00171782

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

Responsible Party: Novartis Identifier: NCT00171782     History of Changes
Other Study ID Numbers: CVAH631BCO02
Study First Received: September 13, 2005
Last Updated: November 7, 2011

Keywords provided by Novartis:

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists processed this record on May 25, 2017