Tracking Information
Start Date ICMJE | November 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: December 14, 2009) | Major adverse cardiovascular events, including CV death, nonfatal MI, and nonfatal stroke [ Time Frame: Time to event (approximately 4 years) ] [ Designated as safety issue: Yes ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT01032629 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: December 14, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | CANVAS - CANagliflozin cardioVascular Assessment Study |
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Official Title ICMJE | A Randomized, Multicenter, Double-Blind, Parallel, Placebo-Controlled Study of the Effects of JNJ 28431754 on Cardiovascular Outcomes in Adult Subjects With Type 2 Diabetes Mellitus |
Brief Summary | The study will assess canagliflozin in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events. Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. |
Detailed Description | The study will evaluate canagliflozin compared to placebo on CV events including CV death, heart attack, and stroke in patients with T2DM, whose diabetes is not well controlled at the beginning of the study and who have a history of CV events or have a high risk for CV events. The study includes 3 substudies which will compare the effectiveness of lowering blood glucose and assess the safety of canagliflozin relative to placebo in patients receiving specific commonly-used diabetes agents. The patients will receive capsules of canagliflozin (either 100 or 300 mg), or matching placebo, taken by mouth, with study duration for individual patients of up to 4 years or longer (additional patients may be recruited and/or a longer study duration planned based on an analysis and recommendation by an independent data monitoring committee). |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 4500 | ||||
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Estimated Completion Date | April 2013 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 30 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Canada, Czech Republic, Estonia, Germany, Hungary, Mexico, Netherlands, Poland, Russian Federation, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT01032629 | ||||
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Responsible Party | Clinical Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | ||||
Study ID Numbers ICMJE | CR016627, CR016627 | ||||
Study Sponsor ICMJE | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | ||||
Collaborators ICMJE | George Institute, Sydney, Australia | ||||
Investigators ICMJE |
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Information Provided By | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |