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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Bethlehem, Pennsylvania 18017
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400 Gresham Dr
Norfolk, Virginia 23507
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Asheville, North Carolina 28801
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Austin, Texas 78751
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Azusa, California 91702
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Columbia, South Carolina 29203
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Conyers, Georgia 30094
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Covina, California 91723
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Dearborn, Michigan 48124
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Edgewater, Florida 32132
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Evergreen Park, Illinois 60805
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Evergreen Park, Illinois 60805
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Flint, Michigan 48504
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Flint, Michigan 48504
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Glendale, Arizona 85308
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Gosford, New South Wales
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Greenville, South Carolina 29605
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Hialeah, Florida 33012
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Houston, Texas 77003
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Houston, Texas 77429
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9 Medical Parkway
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Jupiter, Florida 33458
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Lincoln, Nebraska 68105
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Macon, Georgia 31217
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Metairie, Louisiana 70006
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Orangeburg, South Carolina 29118
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Paducah, Kentucky 42003
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Peoria, Illinois 61603
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Silverdale, Washington 98383
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Summerfield, Florida 34491
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Uniontown, Pennsylvania 15401
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Whittier, California 90603
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15111 Whittier Boulevard
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Willoughby Hills, Ohio 44094
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