Status:
COMPLETED
A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Lead Sponsor:
Pfizer
Conditions:
Diabetic Nephropathies
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
PF-00489791 is an inhibitor of phosphodiesterase type 5. Our hypothesis is that PF-00489791 will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure, improving renal...
Eligibility Criteria
Inclusion
- Male or female subjects greater than or equal to 18 years. Female subjects must be of non-child bearing potential.
- Clinical diagnosis of type 2 diabetes together with stages 3a, 3b or 4 CKD, based on an eGFR of 25-59 mL/min/1.73m2.
- Evidence of persistent, overt albuminuria; defined as a UACR greater than or equal to 300 mg/g (greater than or equal to 33.9 mg/mmol) for greater than 3 months.
Exclusion
- Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
- Subjects with poorly controlled diabetes mellitus, defined as HbA1C \>9%.
- Subjects on combination ACE inhibitor/ARB therapy.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT01200394
Start Date
December 1 2010
End Date
August 1 2013
Last Update
March 12 2019
Active Locations (160)
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1
Saadat Ansari Internal Medicine
Huntsville, Alabama, United States, 35801
2
The Office of Iqbal Saeed MD, LLC
Huntsville, Alabama, United States, 35805
3
AKDHC Medical Research Services, LLC*
Glendale, Arizona, United States, 85306
4
Southwest Clinical Research Institute, LLC
Tempe, Arizona, United States, 85281