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

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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.


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.
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