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Trial record 1 of 1 for:    NCT00287183
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6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria

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ClinicalTrials.gov Identifier: NCT00287183
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : October 1, 2009
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE January 20, 2006
First Posted Date  ICMJE February 6, 2006
Last Update Posted Date October 1, 2009
Study Start Date  ICMJE February 2006
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2007)
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 Measures  ICMJE
 (submitted: February 2, 2006)
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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
  • 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 Measures  ICMJE
 (submitted: February 2, 2006)
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria
Official Title  ICMJE Double-Blind, Randomized, Placebo-Controlled, Phase IIa, Multicenter Study In Patients With Type 2 Diabetes And Persistent Albuminuria To Evaluate The Safety And Efficacy Of A Six Month Regimen Of Orally-Administered TTP488
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 Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Nephropathy
Intervention  ICMJE
  • Drug: PF-04494700 (TTP488)
    60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Active Comparator: PF-04494700 (TTP488)
    Intervention: Drug: PF-04494700 (TTP488)
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 2, 2006)
110
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female outpatients 31 years of age or older.
  • Females must no longer be of child-bearing potential, must have a negative serum pregnancy test, and cannot be breast-feeding.
  • Non-vasectomized male must be willing to abstain from sexual intercourse or willing to use a condom in addition to having their female partner use another form of contraception.
  • Diagnosis of probable Type 2 diabetes after the age of 30 and for at least 6 months prior to the screening visit and: not requiring insulin within first year of diagnosis; no history of diabetic ketoacidosis (DKA); body mass index (BMI) of 40 or less at the screening visit
  • Presence of persistent albuminuria with a UACR of 6.7 - 203 mg/mmol Must be taking the highest tolerated dose of an angiotensin converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB) and have been maintained on that dose for at least 3 months prior to the Baseline visit
  • Blood pressure(BP) must be stable and well controlled by the judgement of the investigator (goal of the control of BP is 130/80 or less). If required, the use of anti-hypertensives in addition to an ACE inhibitor or an ARB is acceptable.
  • Patients with a calculated creatinine clearance of greater than or equal to 30 mL/min and without the presence of clinically significant hematuria or red or white cell casts can be included in the study.

Exclusion Criteria:

  • Diagnosis of Type 1 diabetes
  • Hemoglobin A1c (HbA1c) >10%
  • Females cannot be breast-feeding
  • Known renal artery stenosis
  • Calculated creatinine clearance <30 mL/min or the presence of clinically significant hematuria of red or white cell casts
  • Chronic use of NSAIDs or more than 1 g/day of aspirin
  • QTc >450 msec for females or >430 msec for males (a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle)
  • Known family history of prolonged QT syndrome
  • History of symptomatic congestive heart failure within the last 2 years
  • History of syncope in the lst 2 years or recurrent hypokalemia, including that caused by diuretics
  • Myocardial infarction or signs or symptoms of unstable coronary artery disease with the last year
  • Pulmonary disease or evidence of clinically significant pulmonary symptoms.
  • Active neoplastic disease. (Excised cutaneous basal cell carcinomas are not excluded). Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.
  • Any clinically significant hematologic or coagulation disorder
  • Any clinically significant hepatic disease
  • Use of excluded medications: drugs known to significantly increase QTc and/or have increased risk of torsades de point, immunosuppressive agents, cancer chemotherapeutic agents, oral corticosteroids other than maintenance doses equivalent to 7.5 mg prednisone per day, and radiotherapy
  • Use of an investigational drug within 30 days or within 5 half-lives of the investigational agent, whichever is longer, or use of an investigational medical device within 2 weeks before or after the study
  • Any other disease or condition that, in the opinion of the investigator, makes the patient unsuitable to participate in this study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 31 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00287183
Other Study ID Numbers  ICMJE B0341001
TTP488-202
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP