6-Month Safety And Efficacy Study Of TTP488 In Patients With Type 2 Diabetes And Persistent Albuminuria
NCT ID: NCT00287183
Last Updated: 2009-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
110 participants
INTERVENTIONAL
2006-02-28
2009-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate the Safety and Tolerability of ABT-614 and Its Effect on Kidney Function in Subjects With Type 2 Diabetes and Chronic Kidney Disease With Protein in Their Urine.
NCT01464320
A Phase 2 Study to Evaluate the Safety and Efficacy of CTP-499 in Type 2 Diabetic Nephropathy Patients
NCT01487109
A Single Oral Dose Study Of PF-06409577 In Healthy Adult Subjects
NCT02286882
A Study in Participants With Diabetic Kidney Disease
NCT01113801
Efficacy and Safety of Empagliflozin (BI 10773) in Patients With Type 2 Diabetes and Renal Impairment
NCT01164501
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PF-04494700 (TTP488)
PF-04494700 (TTP488)
60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
Placebo
Placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-04494700 (TTP488)
60 mg/day for 6 days followed by 20 mg/day for 175 days vs placebo, oral medication
Placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
31 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pfizer, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pfizer Investigational Site
Red Deer, Alberta, Canada
Pfizer Investigational Site
Penticton, British Columbia, Canada
Pfizer Investigational Site
Vancouver, British Columbia, Canada
Pfizer Investigational Site
Burlington, Ontario, Canada
Pfizer Investigational Site
Courtice, Ontario, Canada
Pfizer Investigational Site
Fort Erie, Ontario, Canada
Pfizer Investigational Site
Hamilton, Ontario, Canada
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Kitchener, Ontario, Canada
Pfizer Investigational Site
Millon, Ontario, Canada
Pfizer Investigational Site
North Bay, Ontario, Canada
Pfizer Investigational Site
Oakville, Ontario, Canada
Pfizer Investigational Site
Saint Catherines, Ontario, Canada
Pfizer Investigational Site
Scarborough Village, Ontario, Canada
Pfizer Investigational Site
Smith Falls, Ontario, Canada
Pfizer Investigational Site
Thornhill, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Toronto, Ontario, Canada
Pfizer Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TTP488-202
Identifier Type: -
Identifier Source: secondary_id
B0341001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.