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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00280540
First received: January 19, 2006
Last updated: November 5, 2010
Last verified: March 2008
History of Changes

January 19, 2006
November 5, 2010
December 2005
August 2006   (final data collection date for primary outcome measure)
  • Change from baseline systolic blood pressure after 4 weeks
  • Change from baseline systolic blood pressure after 2 and 6 weeks
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Complete list of historical versions of study NCT00280540 on ClinicalTrials.gov Archive Site
  • 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
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Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
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

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).
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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hypertension
Drug: Valsartan/Hydrochlorothiazide
Not Provided
Zappe DH, Palmer BF, Calhoun DA, Purkayastha D, Samuel R, Jamerson KA. Effectiveness of initiating treatment with valsartan/hydrochlorothiazide in patients with stage-1 or stage-2 hypertension. J Hum Hypertens. 2010 Jul;24(7):483-91. Epub 2009 Dec 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
648
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August 2006   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
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Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00280540
CVAH631BUS05
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Novartis
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Study Director: Novartis Pharmaceuticals Novartis
Novartis
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP