Efficacy and Safety of Lercanidipine and Enalapril in Patients With Essential Hypertension

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Placebo
* Drug: Lercanidipine
* Drug: Lercanidipine
* Drug: Enalapril
* Drug: Enalapril
* Drug: Lercanidipine + Enalapril
* Drug: Lercanidipine + Enalapril
* Drug: Lercanidipine + Enalapril
* Drug: Lercanidipine + Enalapril


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* once daily for 10 weeks<br>|
| Experimental: Lercanidipine 10 mg<br> | Drug: Lercanidipine<br>* 10 mg once daily for 10 weeks<br>|
| Experimental: Lercanidipine 20 mg<br> | Drug: Lercanidipine<br>* 20 mg once daily for 10 weeks<br>|
| Experimental: Enalapril 10 mg<br> | Drug: Enalapril<br>* 10 mg once daily for 10 weeks<br>|
| Experimental: Enalapril 20 mg<br> | Drug: Enalapril<br>* 20 mg once daily for 10 weeks<br>|
| Experimental: Lercanidipine 10 mg/Enalapril 10 mg<br> | Drug: Lercanidipine + Enalapril<br>* 10/10 mg once daily for 10 weeks<br>|
| Experimental: Lercanidipine 10mg/Enalapril 20 mg<br> | Drug: Lercanidipine + Enalapril<br>* 10/20 mg once daily for 10 weeks<br>|
| Experimental: Lercanidipine 20mg/Enalapril 10 mg<br> | Drug: Lercanidipine + Enalapril<br>* 20/10 mg once daily for 10 weeks<br>|
| Experimental: Lercanidipine 20mg/Enalapril20mg<br> | Drug: Lercanidipine + Enalapril<br>* 20/20 mg once daily for 10 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting diastolic blood pressure (SDBP) |  | after 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in sitting systolic blood pressure (SSBP) |  | after 10 weeks | 
| Safety parameters: adverse events, heart rate, laboratory tests physical examination |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Lercanidipine, Calcium antagonist, Enalapril