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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00627952

Enrollment

100

Registered

2008-03-04

Start date

2007-11-30

Completion date

2008-12-31

Last updated

2013-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

hypertension, intraglomerular pressure

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.

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.

Interventions

DRUGamlodipine 10 mg

amlodipine 10 mg once daily

DRUGmanidipine 20 mg

manidipine 20 mg once daily

DRUGamlodipine 5 mg + delapril 30 mg

amlodipine 5 mg + delapril 30 mg once daily

DRUGmanidipine 10 mg + delapril 30 mg

manidipine 10 mg + delapril 30 mg once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure	4 weeks

Secondary

Measure	Time frame
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	4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026