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

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: NCT00280540
Recruitment Status : Completed
First Posted : January 23, 2006
Last Update Posted : November 9, 2010
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Valsartan/Hydrochlorothiazide Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 648 participants
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
Study Start Date : December 2005
Actual Primary Completion Date : August 2006

Resource links provided by the National Library of Medicine

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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): NCT00280540

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00280540    
Other Study ID Numbers: CVAH631BUS05
First Posted: January 23, 2006    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: March 2008
Keywords provided by Novartis:
High blood pressure
Blood pressure control
Blood pressure reduction
Additional relevant MeSH terms:
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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