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

February 3, 2009 updated by: Nantes University Hospital
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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France
        • CHU de Nantes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Investigators

  • Principal Investigator: Vincent LM Esnault, MD PHD, CHU de Nantes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BRD 03-5-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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