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

Essential Hypertension Clinical Trial

— FELT  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093807
• Other study ID #: REC 15/2375-IT-CL 0336
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2010
• Last updated: April 28, 2011
• Start date: March 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Recordati Industria Chimica e Farmaceutica S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación ClínicaGermany: Ethics CommissionUkraine: Ministry of HealthRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1039
• Est. completion date: April 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• Placebo
once daily for 10 weeks
• Lercanidipine
10 mg once daily for 10 weeks
• Lercanidipine
20 mg once daily for 10 weeks
• Enalapril
10 mg once daily for 10 weeks
• Enalapril
20 mg once daily for 10 weeks
• Lercanidipine + Enalapril
10/10 mg once daily for 10 weeks
• Lercanidipine + Enalapril
10/20 mg once daily for 10 weeks
• Lercanidipine + Enalapril
20/10 mg once daily for 10 weeks
• Lercanidipine + Enalapril
20/20 mg once daily for 10 weeks

Locations

Country	Name	City	State
France	Hôpital de la Pitié-Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Recordati Industria Chimica e Farmaceutica S.p.A.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in sitting diastolic blood pressure (SDBP)		after 10 weeks	No
Secondary	Change from baseline in sitting systolic blood pressure (SSBP)		after 10 weeks	No
Secondary	Safety parameters: adverse events, heart rate, laboratory tests physical examination		10 weeks	Yes