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

Information source: Recordati Industria Chimica e Farmaceutica S.p.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Essential Hypertension

Intervention: Placebo (Drug); Lercanidipine (Drug); Lercanidipine (Drug); Enalapril (Drug); Enalapril (Drug); Lercanidipine + Enalapril (Drug); Lercanidipine + Enalapril (Drug); Lercanidipine + Enalapril (Drug); Lercanidipine + Enalapril (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Recordati Industria Chimica e Farmaceutica S.p.A.

Official(s) and/or principal investigator(s):
Giuseppe Mancia, Prof, Study Chair, Affiliation: Clinica Medica Ospedale S. Gerardo Università Milano Bicocca Italy

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change from baseline in sitting diastolic blood pressure (SDBP)

Secondary outcome:

Change from baseline in sitting systolic blood pressure (SSBP)

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

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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

Locations and Contacts

Hôpital de la Pitié-Salpétrière, Paris, France
Additional Information

Starting date: March 2010
Last updated: April 28, 2011

Page last updated: August 23, 2015

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