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Completed

NCT Number: NCT00627952

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

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nurnberg

Erlangen, Bavaria, 91054, Germany

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Amlodipine 10 mg

Drug

amlodipine 10 mg once daily

manidipine 20 mg

Drug

manidipine 20 mg once daily

amlodipine 5 mg + delapril 30 mg

Drug

amlodipine 5 mg + delapril 30 mg once daily

manidipine 10 mg + delapril 30 mg

Drug

manidipine 10 mg + delapril 30 mg once daily

Primary outcomes

  1. effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure

    Time frame: 4 weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Chiesi Farmaceutici S.p.A.

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 4, 2008
Registry last updated
Jan 21, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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