Overview

A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy

Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Spironolactone
Criteria
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.