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NCT01032629 · ClinicalTrials.gov registry record · Phase 3
CANVAS - CANagliflozin cardioVascular Assessment Study
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 4,330
- Enrollment target
NCT01032629: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT01032629 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 4,330 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (461% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01032629, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 4,330 participants
- Enrollment target
Study Summary
The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canagliflozin. The data from this study will be combined with the data from CANVAS-R study (Study of the Effects of Canagliflozin on Renal Endpoints in Adult Subjects with T2DM, NCT01989754) in a pre-specified integrated analysis of CV safety outcomes to satisfy US FDA post-marketing requirements for canagliflozin.
Primary Outcome
MACE, defined as a composite of CV death, non-fatal MI, and nonfatal stroke. Adjudication of these events by the Endpoint Adjudication Committee (EAC) was performed in a blinded fashion. Event rate estimated based on the time to the first occurrence of MACE are presented.
Interventions
- DRUG Placebo
- DRUG Canagliflozin (JNJ-28431754) 100 mg
- DRUG Canagliflozin (JNJ-28431754) 300 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,330 participants |
| Start Date | 2009-12-09 |
| Est. Completion | 2017-02-22 |
| Phase | Phase 3 |
What the finished NCT01032629 record still lists
NCT01032629 is an interventional study that assigns participants to a tested intervention. Its 4,330 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (461% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01032629 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01032629 about?
NCT01032629 is a clinical study titled "CANVAS - CANagliflozin cardioVascular Assessment Study". The study will assess canagliflozin (JNJ-28431754) in the treatment of patients with type 2 diabetes mellitus (T2DM) with regard to cardiovascular (CV) risk for major adverse cardiac events (MACE). Other objectives include evaluating the overall safety, tolerability, and effectiveness of canaglifloz...
What is the current status of trial NCT01032629?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,330 participants. The study started on 2009-12-09. Estimated completion is 2017-02-22.
What interventions are being tested in trial NCT01032629?
The interventions under investigation include: Placebo (DRUG), Canagliflozin (JNJ-28431754) 100 mg (DRUG), Canagliflozin (JNJ-28431754) 300 mg (DRUG).
Who is sponsoring clinical trial NCT01032629?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01032629's enrollment target sits among peer trials
4,330 57th of 2000 higher than 1,944 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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