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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00627952 on ClinicalTrials.gov