A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy
Status: | Completed |
---|---|
Conditions: | Diabetic Neuropathy, Renal Impairment / Chronic Kidney Disease, Diabetes |
Therapuetic Areas: | Endocrinology, Nephrology / Urology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/14/2019 |
Start Date: | December 2010 |
End Date: | August 2013 |
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE-DAILY ADMINISTRATION OF A PHOSPHODIESTERASE 5 INHIBITOR (PF-00489791) IN ADULTS WITH TYPE 2 DIABETES AND OVERT NEPHROPATHY
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 function.
will enhance the relaxation of blood vessels within the kidney and so reduce blood pressure,
improving renal function.
Inclusion Criteria:
- 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 Criteria:
- 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.
We found this trial at
62
sites
15111 Whittier Boulevard
Whittier, California 90603
Whittier, California 90603
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