Status:
TERMINATED
A Study To Evaluate The Safety And Tolerability Of PF-03882845 In Patients With Type 2 Diabetic Nephropathy
Lead Sponsor:
Pfizer
Conditions:
Type 2 Diabetic Nephropathy
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 ...
Detailed Description
This study was terminated on 12-Sep-2012; this decision was made due to poor recruitment and overall business strategy. The study was not terminated for safety reasons nor for lack of efficacy.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01488877
Start Date
January 1 2012
End Date
July 1 2012
Last Update
October 29 2013
Active Locations (6)
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1
Pfizer Investigational Site
Chula Vista, California, United States, 91911
2
Pfizer Investigational Site
San Diego, California, United States, 92123
3
Pfizer Investigational Site
DeLand, Florida, United States, 32720
4
Pfizer Investigational Site
Miami, Florida, United States, 33169