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

This study has been terminated.
(difficulty in patients's inclusion)
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200694
First received: September 13, 2005
Last updated: February 3, 2009
Last verified: February 2009
  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 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)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov 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:
Proteinuria
ACEI
ARB
diuretics
blood pressure
renal failure

Additional relevant MeSH terms:
Proteinuria
Signs and Symptoms
Urination Disorders
Urologic Diseases
Urological Manifestations
Ramipril
Valsartan
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

ClinicalTrials.gov processed this record on November 19, 2014