Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.

NCT ID: NCT00200694

Last Updated: 2009-02-04

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-03-31

Brief Summary

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Determine the best strategy for proteinuria lowering in patients with proteinuria \> 1 g/day receiving ACEI and ARB combination: either increase of ACEI and ARB dosage or increase of diuretic dosage.

Detailed Description

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Conditions

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Heavy Proteinuria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Interventions

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ramipril 5 mg + valsartan 80 mg/day,

Intervention Type DRUG

ramipril 10 mg + valsartan 160 mg/day,

Intervention Type DRUG

ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* proteinuria \> 1 g/day with ramipril 5 + valsartan 80 mg/day for 2 months
* proteinuria changes \< 50% on 3 separate dosages over 2 months.

Exclusion Criteria

* age \< 18 or \> 80 years systolic BP \< 110 or ≥ 140 mmHg, serum creatinine \> 250 mmole/L
* serum creatinine increase on ramipril + valsartan \> 20%
* intolerance to ACEI or ARB
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Vincent LM Esnault, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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BRD 03-5-D

Identifier Type: -

Identifier Source: org_study_id

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