Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in 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)...
Brief Summary
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”
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).
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
- Study Primary Completion Date: August 2006
Intervention(s) in this Clinical Trial
- Drug: Valsartan/Hydrochlorothiazide
Outcome Measures for this Clinical Trial
Primary Measures
- Change from baseline systolic blood pressure after 4 weeks
- Change from baseline systolic blood pressure after 2 and 6 weeks
Secondary 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
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 09, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00280540
Study ID Number: CVAH631BUS05
ClinicalTrials.gov Identifier: NCT00280540
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00280540
