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Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension

This study has been completed.
Information provided by:
Novartis Identifier:
First received: January 19, 2006
Last updated: November 5, 2010
Last verified: March 2008
This is a double-blind study to evaluate the reduction in systolic blood pressure using a therapy initiated with valsartan 160 mg or valsartan + hydrochlorothiazide (HCTZ) 160/12.5 mg compared to a more conventional approach (therapy initiated with low-dose valsartan 80 mg).

Condition Intervention Phase
Hypertension Drug: Valsartan/Hydrochlorothiazide Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A 6-week Treatment Regimen Study to Evaluate the Efficacy of Initial High Dose Valsartan Monotherapy (160 mg) or Combo Therapy (Valsartan + Hydrochlorothiazide, 160/12.5 mg) to Conventional Low-dose Valsartan Monotherapy (80 mg) in Managing Patients With Hypertension

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline systolic blood pressure after 4 weeks
  • Change from baseline systolic blood pressure after 2 and 6 weeks

Secondary Outcome Measures:
  • Time in weeks to achieve blood pressure less than 140/90 mmHg over 6 week period
  • Blood pressure less than 140/90 mmHg after 6 weeks
  • Change from baseline diastolic blood pressure after 6 weeks
  • Change from baseline in blood and urine markers after 6 weeks

Estimated Enrollment: 648
Study Start Date: December 2005
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Male or female age 18 or older
  • Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but < 180 mm Hg and mean seated diastolic blood pressure ≥ 90 mm Hg and <110 mm Hg)

Exclusion Criteria:

  • Patients with severe hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
  • History of secondary hypertension (including primary aldosteronism, renovascular hypertension, pheochromocytoma etc.)
  • History of myocardial infarction, stroke [e.g. cerebrovascular accident (CVA), thrombotic stroke, transient ischemic attack (TIA)], or onset of heart failure within the last 6 months.

Other protocol-defined inclusion/exclusion criteria may apply.

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Please refer to this study by its identifier: NCT00280540

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Study Director: Novartis Pharmaceuticals Novartis
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00280540     History of Changes
Other Study ID Numbers: CVAH631BUS05
Study First Received: January 19, 2006
Last Updated: November 5, 2010

Keywords provided by Novartis:
High blood pressure
Blood pressure control
Blood pressure reduction

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 processed this record on August 23, 2017