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

This study has been terminated.
(difficulty in patients's inclusion)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00200694
First Posted: September 20, 2005
Last Update Posted: February 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nantes University Hospital
  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
Intervention Model: Crossover Assignment
Masking: None (Open Label)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00200694     History of Changes
Other Study ID Numbers: BRD 03-5-D
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Nantes University Hospital:
Proteinuria
ACEI
ARB
diuretics
blood pressure
renal failure

Additional relevant MeSH terms:
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Valsartan
Ramipril
Furosemide
Diuretics
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs
Sodium Potassium Chloride Symporter Inhibitors
Membrane Transport Modulators
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors