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

September 13, 2005
February 3, 2009
March 2005
March 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00200694 on ClinicalTrials.gov Archive Site
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Anti-Proteinuric Response to ACEI, ARB and Diuretics Combination.
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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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
18
March 2007
March 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00200694
BRD 03-5-D
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Nantes University Hospital
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Principal Investigator: Vincent LM Esnault, MD PHD CHU de Nantes
Nantes University Hospital
February 2009

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