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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 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 4,330 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01032629
The ClinicalTrials.gov registry entry for NCT01032629 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,330 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01032629 reports 0 study locations.
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.
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