Phase 2 PF-00489791 IN ADULTS WITH TYPE 2 DIABETES
Research type
Research Study
Full title
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
IRAS ID
68880
Contact name
Abdul Meguid El Nahas
Sponsor organisation
Pfizer Inc, Ramsgate Road, Sandwich, Kent, CT139NJ
Eudract number
2010-021358-20
Clinicaltrials.gov Identifier
Research summary
One of the main things that a person??s kidneys do is to ??clean?? their blood. They remove harmful waste, toxins and excess water from the body. When kidneys are damaged they do not work properly. This can make a person feel ill, making them very tired, lose their appetite or have itchy skin. A7731011 is a Phase 2 study to find out if the study drug can make damaged kidneys work better in patients with type II diabetes. PF 00489791 is a new investigational drug. Whilst the mechanism is not yet fully understood, it is believed that the study drug may improve the blood flow and blood pressure within the kidney. This is a ??double-blind?? study, which means neither the subject nor the study team will know if the subject has been assigned to receive PF 00489791 or placebo. This is done to make sure the results of the study cannot be unfairly flunced by anyone Subject will either be assigned to PF-00489791 20 mg or placebo QD in a 3:1 ratio. Therefore the subjects will have a 75% chance (3 in 4) of receiving PF 00489791 and a 25% chance (1 in 4) of receiving placebo. All patients, including placebo patients, will receive standard of care so will not be deprived of any medicines required to treat their chronic kidney disease. Other purposes of the study are to assess how safe PF-00489791is to take and whether it have fewer side effects than other treatment. The study is being sponsored by Pfizer. There will be approximately 230 people enrolled in this study at approx 40-60 sites across 11 countries; of these the UK will recruit approx 20 patients at approx 7-9 sites. Patients will undergo a number of trial related assessments including blood and urine tests, Physical examination, and ECGs. The patient will be in this study for approximately 20 weeks. They will need to visit the research site at least 6 times during the study.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
11/H1306/7
Date of REC Opinion
7 Mar 2011
REC opinion
Further Information Favourable Opinion