A Study to Evaluate the Combination of Valsartan + Amlodipine in Hypertensive Patients
Phase 3
Completed
- Conditions
- Hypertension
- Registration Number
- NCT00392262
- Lead Sponsor
- Novartis
- Brief Summary
The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with amlodipine or felodipine alone.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
Inclusion Criteria
- Male or female patients (18 years)
- Patients with moderate essential hypertension (untreated must have MSSBP ≥160 and <180 mmHg at Visit 1, treated must have MSSBP <180 mmHg at Visit 1) (WHO grade II)
Read More
Exclusion Criteria
- Severe hypertension(MSDBP ≥110 mmHg or MSSBP ≥ 180 mmHg)
- Pregnant or nursing women
- Treated hypertensive patients with controlled hypertension under current therapy (diastolic BP < 90 mmHg and systolic BP < 140 mmHg)
- A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
Other protocol-defined inclusion/exclusion criteria may apply.
Read More
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To investigate whether 4 weeks treatment with valsartan 160mg + amlo 5mg provide an add'l mean sitting systolic blood pressure reduction in patients not adequately responding to 4 weeks treatment with amlo 5mg or felodipine 5mg
- Secondary Outcome Measures
Name Time Method Responder rate. (analogously & explorative) Normalization (analogously & explorative) Mean sitting diastolic blood pressure (analogously & explorative)
Trial Locations
- Locations (1)
Novartis
🇨🇭Basel, Switzerland