Status:
COMPLETED
A Study on the Effect of Kidney Disease on a Diabetes Medication (0431-008)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Renal Insufficiency
Hemodialysis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A study to evaluate the effect of kidney disease, from mild to severe disease, on a diabetes medication
Eligibility Criteria
Inclusion
- Inclusion Criteria :
- Male and non-pregnant females with a clinical diagnosis of renal insufficiency with mild, moderate, severe or end stage renal disease on hemodialysis
- A body mass index of less than 40 kg per meter squared (body weight in kg divided by height in meters squared)
- Smokes less than 10 cigarettes/day
- Exclusion Criteria :
- Patients with uncontrolled diabetes or uncontrolled congestive heart failure
- Patient has abnormal prestudy laboratory measurements including serum potassium or white blood counts
- Patient has systolic blood pressure below 100 mm Hg or above 180 mm Hg
- Patient has diastolic blood pressure less than 50 mm Hg systolic or above 100 mmHg
Exclusion
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2003
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00418366
Start Date
January 1 2003
End Date
March 1 2003
Last Update
August 19 2015
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