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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

This study has been completed.
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Roland E. Schmieder, University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00627952
First received: February 24, 2008
Last updated: January 18, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: amlodipine 10 mg
Drug: manidipine 20 mg
Drug: amlodipine 5 mg + delapril 30 mg
Drug: manidipine 10 mg + delapril 30 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: November 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: amlodipine 10 mg Drug: amlodipine 10 mg
amlodipine 10 mg once daily
Drug: amlodipine 5 mg + delapril 30 mg
amlodipine 5 mg + delapril 30 mg once daily
Active Comparator: manidipine 20 mg Drug: manidipine 20 mg
manidipine 20 mg once daily
Drug: manidipine 10 mg + delapril 30 mg
manidipine 10 mg + delapril 30 mg once daily

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00627952

Locations
Germany
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Chiesi Farmaceutici S.p.A.
Investigators
Principal Investigator: Roland E Schmieder, Professor University of Erlangen-Nürnberg
  More Information

No publications provided

Responsible Party: Roland E. Schmieder, Prof. Dr. med., University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00627952     History of Changes
Other Study ID Numbers: 2006-006350-10, MANTRA
Study First Received: February 24, 2008
Last Updated: January 18, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Erlangen-Nürnberg Medical School:
hypertension
intraglomerular pressure

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Manidipine
Delapril
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013