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Bosentan Use in Patients With Diabetic Nephropathy

NCT00638131 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-07-24

No results posted yet for this study

Summary

There is little doubt of the necessity for further improvement in the prevention and therapy of end-stage renal disease. Despite the success of ARB in treating diabetic nephropathy, not all patients obtain satisfactory control of blood pressure, albuminuria and decline in renal function. Experimental data have provided us with a rationale for the potential added benefits of ET receptor blockade to the AII inhibition in diabetic renal protection. Considering the nephroprotective effect of bosentan in diabetic rats, clinical studies are warranted to assess whether ET receptor antagonism has additive renoprotective effects on top of AII inhibition.

Conditions

Interventions

DRUG

bosentan

62.5mg bid x4 weeks, up-titrate to 125mg bid x12 weeks

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Maryse Courteau, MD · CHUM

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2010-03-31
Completion
2010-06-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00638131 on ClinicalTrials.gov