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
Abstract
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.
Conditions: Diabetic Nephropathies.
Primary outcome: Change From Baseline in Urinary Albumin Creatinine Ratio (UACR) at Week 12.
Enrollment: 256 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 256 participants or records.
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