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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287183
Recruitment Status : Completed
First Posted : February 6, 2006
Last Update Posted : October 1, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Diabetic Nephropathy Drug: PF-04494700 (TTP488) Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Of A Six Month Regimen Of Orally-Administered TTP488
Study Start Date : February 2006
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: PF-04494700 (TTP488) Drug: PF-04494700 (TTP488)
60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication

Placebo Comparator: Placebo Other: Placebo

Primary Outcome Measures :
  1. 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). ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   31 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287183

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Canada, Alberta
Pfizer Investigational Site
Red Deer, Alberta, Canada, T4N 6V7
Canada, British Columbia
Pfizer Investigational Site
Penticton, British Columbia, Canada, V2A 5C8
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V6E 1M7
Canada, Ontario
Pfizer Investigational Site
Burlington, Ontario, Canada, L7M 4Y1
Pfizer Investigational Site
Courtice, Ontario, Canada, L1E 3C3
Pfizer Investigational Site
Fort Erie, Ontario, Canada, L2A 1Z3
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8M 1K7
Pfizer Investigational Site
Kitchener, Ontario, Canada, N2G 1N9
Pfizer Investigational Site
Kitchener, Ontario, Canada, N2H 5Z8
Pfizer Investigational Site
Millon, Ontario, Canada, L9T 0H7
Pfizer Investigational Site
North Bay, Ontario, Canada, P1B 2H3
Pfizer Investigational Site
Oakville, Ontario, Canada, L6H 3P1
Pfizer Investigational Site
Saint Catherines, Ontario, Canada, L2N 7H8
Pfizer Investigational Site
Scarborough, Ontario, Canada, M1H 3G4
Pfizer Investigational Site
Smith Falls, Ontario, Canada, K7A 4W8
Pfizer Investigational Site
Thornhill, Ontario, Canada, L4J 8L7
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N-3M5
Pfizer Investigational Site
Toronto, Ontario, Canada, M4R 2G4
Canada, Saskatchewan
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada, S7K 0H6
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc. Identifier: NCT00287183    
Other Study ID Numbers: B0341001
First Posted: February 6, 2006    Key Record Dates
Last Update Posted: October 1, 2009
Last Verified: September 2009
Additional relevant MeSH terms:
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Diabetic Nephropathies
Kidney Diseases
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Urination Disorders
Urological Manifestations