Completed
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, 24-Week Study to Evaluate the Safety and Tolerability of Pyridorin (Pyridoxamine Dihydrochloride) in Patients With Diabetic Nephropathy Associated With Type 1 or Type 2 Diabetes
Led by BioStratum · Updated on 2006-04-27
128
Participants Needed
N/A
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of the study is to evaluate the safety and tolerability of Pyridorin (pyridoxamine dihydrochloride) 50 mg given orally twice daily in patients with diabetic kidney disease.
CONDITIONS
Brief Title
Effect of Pyridorin in Patients With Diabetic Nephropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
-
Males and Females (non-pregnant and non-lactating) between 18 and 70 years of age with type 1 or type 2 diabetes
-
Sitting blood pressure of <=170/100 mm Hg at weeks -2 and -1
-
Hemoglobin A1C <=12% at week -2
-
Patients with diagnosis of diabetic nephropathy as defined by
- Serum Creatinine <=2.0 mg/dL at weeks -2 and -1
- Urinary albumin excretion >=300 mg/24 hours at week -2
- Diagnosis of diabetic retinopathy
-
Creatinine clearance >=40 mL/min at weeks -2 and -1
-
Voluntary written consent to participate in this study
You will not qualify if you...
- History of allergic or adverse response to any B vitamin
- History of major cardiovascular or cerebrovascular events
- History of cancer except adequately treated basal or squamous cell carcinoma of the skin
- History of diabetic ketoacidosis
Trial Site Locations
Site Locations not provided
Location information for this trial is currently unavailable.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
0
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