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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

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.

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: amlodipine 10 mg
• Active Comparator: manidipine 20 mg

Primary Measures

• effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure
  • Time Frame: 4 weeks
    Safety Issue?: Yes

Secondary 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
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Erlangen-Nürnberg

Overall Clinical Trial Officials and Contacts

Roland E Schmieder, Professor Principal Investigator University of Erlangen-Nürnberg  

Overall Contact: Roland E Schmieder, Prof. 004991318536245 roland.schmieder@uk-erlangen.de

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00627952

Study ID Number: 2006-006350-10

ClinicalTrials.gov Identifier: NCT00627952

Health Authority: Germany: Federal Institute for Drugs and Medical Devices