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 Overview
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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.

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.

Official Title
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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

Conditions
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Hypertension

Intervention / Treatment
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* Drug: amlodipine 10 mg
* Drug: manidipine 20 mg
* Drug: amlodipine 5 mg + delapril 30 mg
* Drug: manidipine 10 mg + delapril 30 mg


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: amlodipine 10 mg<br> | Drug: amlodipine 10 mg<br>* amlodipine 10 mg once daily<br>Drug: amlodipine 5 mg + delapril 30 mg<br>* amlodipine 5 mg + delapril 30 mg once daily<br>|
| Active Comparator: manidipine 20 mg<br> | Drug: manidipine 20 mg<br>* manidipine 20 mg once daily<br>Drug: manidipine 10 mg + delapril 30 mg<br>* manidipine 10 mg + delapril 30 mg once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effect of manidipine 20 mg once daily compared to amlodipine 10 mg once daily on intraglomerular pressure |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, intraglomerular pressure