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

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

February 3, 2009

Start Date ^ICMJE

March 2005

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00200694 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Brief Summary

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

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Condition ^ICMJE

Heavy Proteinuria

Intervention ^ICMJE

Drug: ramipril 5 mg + valsartan 80 mg/day,
Drug: ramipril 10 mg + valsartan 160 mg/day,
Drug: ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

March 2007

Primary Completion Date

March 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00200694

Responsible Party

Study ID Numbers ^ICMJE

BRD 03-5-D

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Vincent LM Esnault, MD PHD

CHU de Nantes

Information Provided By

Nantes University Hospital

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP