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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
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, see Learn About Clinical Studies.

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
Health Authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos

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 October 20, 2016