Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01327846 · ClinicalTrials.gov registry record · Phase 3
Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 10,066
- Enrollment target
NCT01327846 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 10,066 participants.
The verdict
NCT01327846, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 10,066 participants
- Enrollment target
Study Summary
Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the extension phase of the main study is to collect additional long-term safety data on continued exposure to canakinumab in patients who participated in the pivotal phase. Sub-study 1 (CACZ885M2301S1): The purpose of this sub-study was to evaluate the effect of quarterly subcutaneous canakinumab treatment for 24 months comparted with placebo on the carotid plaque burden measured by integrated vascular MRI in patients enrolled in the CACZ885M2301 study (CANTOS). Sub-study 2 (CACZ885M2301S2): The purpose of this CANTOS sub-study was to determine whether, in patients with type 2 diabetes participating in the CANTOS main study, canakinumab compared to placebo, on top of standard of care could increase insulin secretion and insulin sensitivity.
Interventions
- DRUG Placebo
- DRUG Canakinumab
- DRUG Standard of care
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10,066 participants |
| Start Date | 2011-04-11 |
| Est. Completion | 2019-04-14 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01327846
The ClinicalTrials.gov registry entry for NCT01327846 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 10,066 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01327846 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01327846 about?
NCT01327846 is a clinical study titled "Cardiovascular Risk Reduction Study (Reduction in Recurrent Major CV Disease Events)". Main Study (CACZ885M2301): The purpose of the pivotal phase of this trial was to test the hypothesis that canakinumab treatment of patients with myocardial infarction (MI) at least one month prior to study entry and elevated hsCRP could prevent recurrent cardiovascular events. The purpose of the ex...
What is the current status of trial NCT01327846?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 10,066 participants. The study started on 2011-04-11. Estimated completion is 2019-04-14.
What interventions are being tested in trial NCT01327846?
The interventions under investigation include: Placebo (DRUG), Canakinumab (DRUG), Standard of care (DRUG).
Who is sponsoring clinical trial NCT01327846?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.