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
NCT00627952 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2013-01-21
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.
Conditions
Interventions
- 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
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
collaborator INDUSTRY -
University of Erlangen-Nürnberg Medical School
lead OTHER
Principal Investigators
-
Roland E Schmieder, Professor · University of Erlangen-Nürnberg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-11-30
- Primary Completion
- 2008-12-31
- Completion
- 2008-12-31
Countries
- Germany
Study Locations
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