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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

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ClinicalTrials.gov Identifier: NCT00627952
Recruitment Status : Completed
First Posted : March 4, 2008
Last Update Posted : January 21, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment 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

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : November 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 4, 2008    Key Record Dates
Last Update Posted: January 21, 2013
Last Verified: January 2013

Keywords provided by Roland E. Schmieder, University of Erlangen-Nürnberg Medical School:
hypertension
intraglomerular pressure

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