Status:
COMPLETED
Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension
Lead Sponsor:
Novartis
Conditions:
Essential Hypertension ( Mild to Moderate)
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blo...
Eligibility Criteria
Inclusion
- Outpatients ≥ 18 years of age
- Patients with a diagnosis of mild to moderate hypertension at Visit 1
- All patients must have a msSBP ≥ 140 mmHg and \< 180 mmHg and/or msDBP ≥ 90 mmHg and \< 110 mmHg mmHg at Visit 3
Exclusion
- Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg
- Secondary form of hypertension
- Current diagnosis of heart failure (NYHA Class II-IV)
- Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
- Second or third degree heart block without a pacemaker
- Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1
- Other protocol-defined inclusion/exclusion criteria may apply.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00765947
Start Date
September 1 2008
End Date
August 1 2009
Last Update
August 6 2020
Active Locations (4)
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1
Investigative Site
Paris, France
2
Investigative Site
Budapest, Hungary
3
Investigative Site
Bucharest, Romania
4
Investigative Site
Bratislava, Slovakia