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NCT00200694 Clinical Trial

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

Heavy Proteinuria Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00200694
Other study ID # BRD 03-5-D
Secondary ID
Status Terminated
Phase Phase 4
First received September 13, 2005
Last updated February 3, 2009
Start date March 2005
Est. completion date March 2007

Study information
Verified date February 2009
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 18
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Drug:
• ramipril 5 mg + valsartan 80 mg/day,

• ramipril 10 mg + valsartan 160 mg/day,

• ramipril 5 mg + valsartan 80 mg/day + increased dosage of furosémide.

Locations
Country Name City State
France CHU de Nantes Nantes

Sponsors (1)
Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France,