Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension
Phase 2
Completed
- Conditions
- Essential Hypertension
- Interventions
- Registration Number
- NCT01093807
- Lead Sponsor
- RECORDATI GROUP
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1039
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Lercanidipine 20mg/Enalapril20mg Lercanidipine + Enalapril - Placebo Placebo - Lercanidipine 10 mg Lercanidipine - Lercanidipine 20 mg Lercanidipine - Lercanidipine 10 mg/Enalapril 10 mg Lercanidipine + Enalapril - Lercanidipine 10mg/Enalapril 20 mg Lercanidipine + Enalapril - Lercanidipine 20mg/Enalapril 10 mg Lercanidipine + Enalapril - Enalapril 10 mg Enalapril - Enalapril 20 mg Enalapril -
- Primary Outcome Measures
Name Time Method Change from baseline in sitting diastolic blood pressure (SDBP) after 10 weeks
- Secondary Outcome Measures
Name Time Method Change from baseline in sitting systolic blood pressure (SSBP) after 10 weeks Safety parameters: adverse events, heart rate, laboratory tests physical examination 10 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms of lercanidipine and enalapril in treating essential hypertension?
How does the combination of lercanidipine and enalapril compare to standard-of-care antihypertensive therapies in efficacy and safety?
Which biomarkers are associated with improved outcomes in patients treated with lercanidipine and enalapril combinations?
What are the potential adverse events of lercanidipine and enalapril combinations and how are they managed?
Are there alternative calcium channel blocker and ACE inhibitor combinations that show better therapeutic profiles for essential hypertension?
Trial Locations
- Locations (1)
Hôpital de la Pitié-Salpétrière
🇫🇷Paris, France
Hôpital de la Pitié-Salpétrière🇫🇷Paris, France