At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 256 enrolled
Drug / intervention
PF-00489791 +1 moredrug
Likely dose
PF-00489791 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating PF-00489791 and Placebo for Diabetic Nephropathies. Completed, enrolled 256 participants across 160 sites in 15 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Nephropathies
CountriesAustralia, Canada, Denmark, Hong Kong, India, Malaysia, Mexico, Poland, Serbia, Slovakia, South Africa, South Korea, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartDec 2010
Primary CompletionJul 2013
Study CompletionAug 2013
TodayJul 2026
First PostedSep 13, 2010
Enrollment StartDec 1, 2010
Primary CompletionJul 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.8 years ago
Interventions
PF-00489791drug
Tablet, 20 mg once daily for 12 weeks
Placebodrug
Tablet, placebo once daily for 12 weeks