Clinical Trial: 6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multicenter Study In Patients With Type 2 Diabetes And Persistent Albuminuria To Evaluate The Safety And Efficacy

Brief Summary: Current research indicates that TTP488 may be a viable agent for the treatment of diabetic nephropathy. The purpose of this study is to determine the safety and efficacy of a six-month regimen of daily orally-administered TTP488 to patients with diabetic nephropathy.

Detailed Summary:
Sponsor: Pfizer

Current Primary Outcome: Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in urinary albumin-creatinine ratio (UACR) [ Time Frame: from baseline to end of treatment (Month 6). ]

Original Primary Outcome: Primary endpoint of efficacy will be assessed by comparing the treatment groups based on the change in UACR from baseline to end of treatment (Month 6).

Current Secondary Outcome:

  • To evaluate treatment on estimated GFR and serum creatinine [ Time Frame: evaluated for change from baseline to months 3 & 6 ]
  • To evaluate the effects of TTP488 on other relevant biomarkers [ Time Frame: evaluated at months 1, 3 & 6 ]
  • To evaluate the safety of TTP488 [ Time Frame: Ongoing ]
  • To evaluate the PK profile of oral TTP488. [ Time Frame: Ongoing ]
  • To evaluate the effect of treatment with TTP488 on UACR [ Time Frame: evaluated from baseline to month 3 visit ]


Original Secondary Outcome:

  • To evaluate the effect of three months of treatment with TTP488 on UACR.
  • To evaluate 3 and 6-months of treatment on estimated glomerular filtration rate and serum creatinine.
  • To evaluate the effects of TTP488 on other relevant biomarkers.
  • To evaluate the safety of TTP488
  • To evaluate the pharmacokinetic profile of oral TTP488.


Information By: Pfizer

Dates:
Date Received: January 20, 2006
Date Started: February 2006
Date Completion:
Last Updated: September 30, 2009
Last Verified: September 2009