6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria
NCT00287183
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
- 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
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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 |
| |||
Study Arms ICMJE |
| |||
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 | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |