Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00273299
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 607
Inclusion Criteria
- Diagnosed severe hypertension
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Exclusion Criteria
- Inability to discontinue all prior antihypertensive medications
- Heart failure of any kind
- History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
- Diabetes with poor glucose control
- Allergy to certain medications used to treat high blood pressure
Other protocol-defined exclusion criteria may apply.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Blood pressure less than 140/90 mmHg after 4 weeks
- Secondary Outcome Measures
Name Time Method Blood pressure less than 140/90 mmHg after 6 weeks Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks Systolic blood pressure less than 140 mmHg after 4 and 6 weeks Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks Adverse events and serious adverse events at each study visit for 6 weeks
Trial Locations
- Locations (1)
Novartis Pharmaceuticals
🇺🇸East Hanover, New Jersey, United States