NCT01093807
Completed
Phase 2
Randomized, Parallel Group, Double-blind Trial to Evaluate Different Dose Combinations of Lercanidipine and Enalapril in Comparison With Each Component Administered Alone and With Placebo in Patients With Essential Hypertension
ConditionsEssential Hypertension
Overview
- Phase
- Phase 2
- Intervention
- Lercanidipine + Enalapril
- Conditions
- Essential Hypertension
- Sponsor
- RECORDATI GROUP
- Enrollment
- 1039
- Locations
- 1
- Primary Endpoint
- Change from baseline in sitting diastolic blood pressure (SDBP)
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of various dosage combinations of lercanidipine (10 and 20 mg)and enalapril (10 and 20 mg) in comparison with their respective components and with placebo.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Office Blood Pressure (BP): Sitting diastolic blood pressure (SDBP)100-109 mmHg (inclusive) and sitting systolic blood pressure (SSBP) \< 180 mmHg after a 2 week placebo run-in period
- •Home Blood Pressure: diastolic blood pressure (DBP)at home ≥ 85 mmHg in the last week of the placebo run-in period
- •Normal Electrocardiogram (ECG), first degree Atrioventricular block or other changes not considered clinically significant
Exclusion Criteria
- •Secondary or severe hypertension
- •History of cerebro- or cardiovascular complications
- •Type 1 or Type 2 diabetes on drug treatment
- •Severe renal or hepatic insufficiency
Arms & Interventions
Lercanidipine 10 mg/Enalapril 10 mg
Intervention: Lercanidipine + Enalapril
Lercanidipine 10mg/Enalapril 20 mg
Intervention: Lercanidipine + Enalapril
Placebo
Intervention: Placebo
Lercanidipine 10 mg
Intervention: Lercanidipine
Lercanidipine 20 mg
Intervention: Lercanidipine
Enalapril 10 mg
Intervention: Enalapril
Enalapril 20 mg
Intervention: Enalapril
Lercanidipine 20mg/Enalapril 10 mg
Intervention: Lercanidipine + Enalapril
Lercanidipine 20mg/Enalapril20mg
Intervention: Lercanidipine + Enalapril
Outcomes
Primary Outcomes
Change from baseline in sitting diastolic blood pressure (SDBP)
Time Frame: after 10 weeks
Secondary Outcomes
- Change from baseline in sitting systolic blood pressure (SSBP)(after 10 weeks)
- Safety parameters: adverse events, heart rate, laboratory tests physical examination(10 weeks)
Study Sites (1)
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