A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Diabetes |
| Therapuetic Areas: | Endocrinology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | January 2012 |
| End Date: | June 2013 |
| Contact: | Pfizer CT.gov Call Center |
| Phone: | 1-800-718-1021 |
A 2-week, Phase 1b, Randomized, Double-Blind, Placebo- Controlled, Multi-Dose, Dose-Escalating Study With PF-03882845 And One Dose Of Spironolactone To Evaluate Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Subjects With Type 2 Diabetes Mellitus And Albuminuria
PF-03882845 is a compound proposed for treatment of type 2 diabetic nephropathy. The primary
purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and
pharmacodynamics of multiple doses of PF-03882845 in this population.
Inclusion Criteria:
- Males and/or Females between 18-65 years, inclusive.
- Body mass index of 18.5 to 45.4 kg/m2 at screening, inclusive. body weight equals or
greater than 110 lb.
- Have type 2 diabetes mellitus.
- On stable dose of anti-diabetic and anti-hypertensive medication prior to screening.
Exclusion Criteria:
- Recent evidence or medical history of unstable concurrent disease.
- Cardiovascular event within 3 months prior to screening.
- History of renal transplant.
- History of hospitalization for acute kidney injury or acute kidney dialysis within 6
months prior to screening.
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