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

This study has been terminated.

( difficulty in patients's inclusion )

First Received: September 13, 2005 Last Updated: February 3, 2009 History of Changes

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200694

Purpose

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.

Condition	Intervention	Phase
Heavy Proteinuria	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.	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study

Resource links provided by NLM:

Drug Information available for: Furosemide Ramipril Valsartan

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Estimated Enrollment:	18
Study Start Date:	March 2005
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200694

Locations

France
CHU de Nantes
Nantes, France

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Vincent LM Esnault, MD PHD

CHU de Nantes

More Information

No publications provided

Study ID Numbers:	BRD 03-5-D
Study First Received:	September 13, 2005
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00200694 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Proteinuria
ACEI
ARB

diuretics
blood pressure
renal failure

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Urination Disorders
Diuretics
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Ramipril
Pharmacologic Actions

Protease Inhibitors
Urological Manifestations
Signs and Symptoms
Proteinuria
Urologic Diseases
Natriuretic Agents
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Valsartan

ClinicalTrials.gov processed this record on November 09, 2009