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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2008-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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amlodipine 10 mg

Group Type ACTIVE_COMPARATOR

amlodipine 10 mg

Intervention Type DRUG

amlodipine 10 mg once daily

amlodipine 5 mg + delapril 30 mg

Intervention Type DRUG

amlodipine 5 mg + delapril 30 mg once daily

manidipine 20 mg

Group Type ACTIVE_COMPARATOR

manidipine 20 mg

Intervention Type DRUG

manidipine 20 mg once daily

manidipine 10 mg + delapril 30 mg

Intervention Type DRUG

manidipine 10 mg + delapril 30 mg once daily

Interventions

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amlodipine 10 mg

amlodipine 10 mg once daily

Intervention Type DRUG

manidipine 20 mg

manidipine 20 mg once daily

Intervention Type DRUG

amlodipine 5 mg + delapril 30 mg

amlodipine 5 mg + delapril 30 mg once daily

Intervention Type DRUG

manidipine 10 mg + delapril 30 mg

manidipine 10 mg + delapril 30 mg once daily

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No