Efficacy and Safety of Valsartan/Hydrochlorothiazide Combination Therapy in Patients With Hypertension
This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy...
Brief Summary
Official Title: “A 28-week, Multicenter Study to Evaluate the Effects of Valsartan/Hydrochlorothiazide (160/12.5 mg) in Comparison With Hydrochlorothiazide (25 mg) Monotherapy, for the Treatment of Patients With Hypertension, Uncontrolled by Hydrochlorothiazide (12.5 mg) Monotherapy”
This study will assess the efficacy and safety of valsartan/hydrochlorothiazide combination therapy in patients with hypertension not controlled with hydrochlorothiazide monotherapy.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
- Study Primary Completion Date: November 2005
Intervention(s) in this Clinical Trial
- Drug: Valsartan/Hydrochlorothiazide
- 160/12.5 mg taken once daily orally
- Drug: HCTZ
- 25 mg taken once daily orally
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: valsartan HCTZ
- Active Comparator: HCTZ
Outcome Measures for this Clinical Trial
Primary Measures
- Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 4 weeks
- Blood pressure control (systolic blood pressure <140 and diastolic blood pressure <90mmHg) after 2 weeks and 20 weeks
Secondary Measures
- Change from baseline in systolic blood pressure after 2 weeks and 4 weeks
- Change from baseline in diastolic blood pressure after 2 weeks and 4 weeks
- Change in systolic blood pressure at 20 weeks compared to 4 weeks
- Change in diastolic blood pressure at 20 weeks compared to 4 weeks
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Male or female 18 years of age and older
- Diagnosed as having hypertension (mean seated systolic blood pressure ≥ 150 mm Hg but
- < 180 mm Hg and mean seated diastolic blood pressure ≥ 95 mm Hg and <110 mm Hg
Exclusion Criteria:
- - Patients with sever hypertension: Systolic ≥ 180 mm Hg or Diastolic ≥ 110 mm Hg
- Diabetes with fasting glucose > 126 mg/dl or on existing anti-diabetic medication
- History of stroke, transient ischemic attack, or myocardial infarction within the last 6 months, or diagnosed with congestive heart failure.
- 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
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Novartis Industry
Overall Clinical Trial Officials and Contacts
Novartis 862-778-8300 Pharmaceuticals Study Director Novartis
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00277472
Study ID Number: CVAH631BUS04
ClinicalTrials.gov Identifier: NCT00277472
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00277472
