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

RECORDATI GROUP1,039 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

1,039

Conditions

Essential Hypertension

Interventions

PlaceboDRUG

once daily for 10 weeks

LercanidipineDRUG

10 mg once daily for 10 weeks

LercanidipineDRUG

20 mg once daily for 10 weeks

Enalapril

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Hôpital de la Pitié-Salpétrière

Paris, France

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)

Time frame: after 10 weeks

Safety parameters: adverse events, heart rate, laboratory tests physical examination

Time frame: 10 weeks

Data from ClinicalTrials.gov

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