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

This study has been terminated.
(difficulty in patients's inclusion)
Information provided by:
Nantes University Hospital Identifier:
First received: September 13, 2005
Last updated: February 3, 2009
Last verified: February 2009
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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label

Resource links provided by NLM:

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)

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

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
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Please refer to this study by its identifier: NCT00200694

CHU de Nantes
Nantes, France
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Vincent LM Esnault, MD PHD CHU de Nantes
  More Information

No publications provided Identifier: NCT00200694     History of Changes
Other Study ID Numbers: BRD 03-5-D
Study First Received: September 13, 2005
Last Updated: February 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
blood pressure
renal failure

Additional relevant MeSH terms:
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses processed this record on December 01, 2015