A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: manidipine 20 mg; Drug: amlodipine 10 mg; Drug: amlodipine 5 mg + delapril 30 mg; Drug: manidipine 10 mg + delapril 30 mg

• Registration Number: NCT00627952
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment (manidipine + delapril or amlodipine + delapril) phase.

Detailed Description

The aim of the current study is to assess the effect of a 4-week single drug treatment with manidipine or amlodipine and a 4-week combination treatment with manidipine plus delapril or amlodipine plus delapril on intraglomerular pressure in subjects with hypertension.

Study Timeline

• Study Start: 2007-11
• Study First Submitted: 2008-02-24
• Study First Submitted QC: 2008-02-24
• Study First Posted: 2008-03-04
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-18
• Last Update Posted: 2013-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• male or female patients aged 18 years or older
• mild to moderate hypertension (systolic blood pressure > 139 mmHg or diastolic blood pressure > 89 mmHg)

Exclusion Criteria

• secondary form of arterial hypertension
• severe hypertension (systolic blood pressure > 179 mmHg or diastolic blood pressure > 109 mmHg)
• pregnant or lactating women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amlodipine 10 mg	amlodipine 5 mg + delapril 30 mg	-
manidipine 20 mg	manidipine 20 mg	-
manidipine 20 mg	manidipine 10 mg + delapril 30 mg	-
amlodipine 10 mg	amlodipine 10 mg	-

Primary Outcome Measures

Name	Time	Method
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure	4 weeks

Secondary Outcome Measures

Name	Time	Method
effects of combination of manidipine 10 mg plus delapril 30 mg once daily compared with once daily amlodipine 5 mg plus delapril 30 mg on intraglomerular pressure	4 weeks

Trial Locations

Locations (1)

Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg; 🇩🇪 Erlangen, Bavaria, Germany