A Phase 2, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of PF-00489791 In Patients With Type 2 Diabetes And Overt Nephropathy

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetic Nephropathies

In brief

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.

Key facts

Study ID

NCT01200394

Run by

Pfizer

People needed

256

Starts

2010-12-01

Expected to finish

2013-08-01

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Office of Iqbal Saeed MD, LLC — Huntsville, Alabama, United States
• AKDHC Medical Research Services, LLC* — Glendale, Arizona, United States
• Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States
• Southwest Clinical Research Institute, LLC — Tempe, Arizona, United States
• North America Research Institute — Azusa, California, United States
• North American Research Institute / California Kidney Specialist — Azusa, California, United States
• Citrus Dialysis Center — Covina, California, United States
• California Institute of Renal Research — La Mesa, California, United States
• Capital Nephrology Clinical Research — Sacramento, California, United States
• California Kidney Specialists — San Dimas, California, United States
• American Institute of Research — Whittier, California, United States
• Whittier Internal Medicine Nephrology Medical Group — Whittier, California, United States
• North Valley Nephrology — Yuba City, California, United States
• Riverside Clinical Research — Edgewater, Florida, United States
• Palm Springs Research Institute — Hialeah, Florida, United States
• ASA Clinical Research, LLC — Jupiter, Florida, United States
• Lakeview Medical Research — Summerfield, Florida, United States
• Rockdale Medical Research Associates — Conyers, Georgia, United States
• Renal Physicians of Georgia — Macon, Georgia, United States
• Boise Kidney and Hypertension Institute — Meridian, Idaho, United States
• Chicago Clinical Research Institute, Inc. — Chicago, Illinois, United States
• Associates in Nephrology, SC — Evergreen Park, Illinois, United States
• Research by Design, LLC — Evergreen Park, Illinois, United States
• RenalCare Associates — Peoria, Illinois, United States
• Saadat Ansari Internal Medicine — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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