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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

U

University of Erlangen-Nürnberg Medical School

Status and phase

Completed
Phase 3

Conditions

Hypertension

Treatments

Drug: amlodipine 10 mg
Drug: manidipine 10 mg + delapril 30 mg
Drug: amlodipine 5 mg + delapril 30 mg
Drug: manidipine 20 mg

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00627952
MANTRA
2006-006350-10

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

100 participants in 2 patient groups

amlodipine 10 mg
Active Comparator group
Treatment:
Drug: amlodipine 10 mg
Drug: amlodipine 5 mg + delapril 30 mg
manidipine 20 mg
Active Comparator group
Treatment:
Drug: manidipine 10 mg + delapril 30 mg
Drug: manidipine 20 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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