A National Multicentre Study to Assess the Efficacy of the Fixed Combination of Valsartan and Amlodipine in Hypertensive Patients Not Controlled by Monotherapy
Phase 4
Completed
- Conditions
- Primary Hypertension
- Interventions
- Drug: valsartan/amlodipine
- Registration Number
- NCT01241487
- Lead Sponsor
- Novartis
- Brief Summary
This study is to assess the efficacy of the fixed combination of Valsartan and Amlodipine in hypertensive patients uncontrolled by monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
- Patient uncontrolled by mono-therapy for at least 8 weeks, having B.P.>/= 140/90 mmHg in non diabetics or >/= 130/80 mmHg in diabetics
Exclusion Criteria
- Patient having B.P.>= 180/110 mmHg in non diabetics or >= 160/100 mmHg in diabetics
- Type 1 Diabetes or uncontrolled type 2 Diabetes.
- PCI in last 12 months.
- Concomitant unstable angina. Other protocol-defined inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 valsartan/amlodipine valsartan/amlodipine
- Primary Outcome Measures
Name Time Method Hypertension in patients that will be controlled on each concentration and those that will switch to the higher concentration (160/10) 4 weeks
- Secondary Outcome Measures
Name Time Method The incidence of Edema 8 weeks Hypertension of patients that were previously controlled on (160/5) and those that were uncontrolled and switched to the higher concentration (160/10) after 4 weeks on (160/5) concentration. 8 weeks Safety and Tolerability of the Trial Medication 8 weeks
Trial Locations
- Locations (1)
Dr Ahmed Anwar Clinic,
🇪🇬Cairo, Egypt