NCT00627952

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

Double Blind, Randomized, Parallel Group, Multicentre Study to Evaluate the Effects of Manidipine 20 MG Vs. Amlodipine 10 MG and the Combination of Manidipine 10 MG Plus Delapril 30 MG Vs. Amlodipine 5 MG Plus Delapril 30 MG on Intraglomerular Pressure in Hypertensive Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Erlangen-Nürnberg Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension

Interventions

Type	Name	Description
DRUG	amlodipine 10 mg	amlodipine 10 mg once daily
DRUG	manidipine 20 mg	manidipine 20 mg once daily
DRUG	amlodipine 5 mg + delapril 30 mg	amlodipine 5 mg + delapril 30 mg once daily
DRUG	manidipine 10 mg + delapril 30 mg	manidipine 10 mg + delapril 30 mg once daily

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-03-04
• Last updated: 2013-01-21

Locations

1 site across 1 country: Germany