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NCT02642159 · ClinicalTrials.gov registry record · Phase 4
Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)
A Phase 4 study of Dyslipidemia, sponsored by Sanofi.
- Completed
- Registry status
- Phase 4
- Development phase
- 413
- Enrollment target
- 20
- Study locations
NCT02642159: Completed Phase 4 study of Dyslipidemia, sponsored by Sanofi.
NCT02642159 is a Phase 4 study of Dyslipidemia that has completed, run by Sanofi. The registered enrollment target is 413 participants, above the 353-participant average among 40 other Dyslipidemia trials with a reported enrollment target (17% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02642159, a Phase 4 study of Dyslipidemia, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 413 participants
- Enrollment target
- 20
- Study locations
Study Summary
Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled with maximally tolerated statin therapy. Secondary Objectives: * To demonstrate whether alirocumab is superior in comparison with usual care in its effects on other lipid parameters (ie, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), total cholesterol (Total -C), lipoprotein a (Lp\[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), triglyceride rich lipoproteins (TGRLs), apolipoprotein A-1 (Apo A-1), apolipoprotein C-III (Apo C-III), lipid subfractions by nuclear magnetic resonance (NMR) spectroscopy (ie, LDL-C particle size and LDL, very low-density lipoprotein \[VLDL\], HDL, and intermediate-density lipoprotein \[IDL\] particle number). * To assess changes in glycemic parameters with alirocumab vs. usual care treatment. * To demonstrate the safety and tolerability of alirocumab. * To evaluate treatment acceptance of alirocumab. * To evaluate proprotein convertase subtilisin kexin type 9 (PCSK9) concentrations and antibody development. * To demonstrate the superiority of alirocumab vs. fenofibrate on non-HDL-C and other lipid parameters (subgroup analysis).
Primary Outcome
Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data from Week 8 to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).
Conditions Studied
Interventions
- DRUG Fenofibrate
- DRUG Ezetimibe
- DRUG Alirocumab
- DRUG Statins
- DRUG Nicotinic acid
Study Locations (20)
California
- Investigational Site Number 840-141 - Fresno
- Investigational Site Number 840-152 - Huntington Beach
- Investigational Site Number 840-115 - La Jolla
- Investigational Site Number 840-118 - Los Angeles
- Investigational Site Number 840-106 - Northridge
- Investigational Site Number 840-176 - Port Hueneme
- Investigational Site Number 840-122 - Tarzana
- Investigational Site Number 840-156 - Tustin
- Investigational Site Number 840-160 - Van Nuys
Florida
- Investigational Site Number 840-107 - Boca Raton
- Investigational Site Number 840-170 - Boynton Beach
- Investigational Site Number 840-114 - Bradenton
- Investigational Site Number 840-132 - Ocoee
- Investigational Site Number 840-179 - Oviedo
- Investigational Site Number 840-123 - Tampa
Georgia
- Investigational Site Number 840-137 - Bainbridge
- Investigational Site Number 840-128 - Columbus
- Investigational Site Number 840-169 - Stockbridge
Arkansas
- Investigational Site Number 840-163 - Little Rock
Idaho
- Investigational Site Number 840-167 - Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 413 participants |
| Start Date | 2016-03-15 |
| Est. Completion | 2017-05-15 |
| Phase | Phase 4 |
What the finished NCT02642159 record still lists
NCT02642159 is an interventional study that assigns participants to a tested intervention. The registered 413 participants enrollment target is mid-sized for trials with a published cap, above the 353-participant average among 40 other Dyslipidemia trials with a reported enrollment target (17% higher).
The record links to 1 condition, with Dyslipidemia appearing as the primary indexed condition, and to 5 interventions - of which Fenofibrate is the first listed.
NCT02642159 names 20 study sites across 5 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT02642159 about?
NCT02642159 is a clinical study titled "Efficacy and Safety of Alirocumab Versus Usual Care on Top of Maximally Tolerated Statin Therapy in Patients With Type 2 Diabetes and Mixed Dyslipidemia (ODYSSEY DM-Dyslipidemia)". Primary Objective: To demonstrate the superiority of alirocumab in comparison with usual care in the reduction of non-high-density lipoprotein cholesterol (non-HDL-C) in participants with type 2 diabetes and mixed dyslipidemia at high cardiovascular risk with non-HDL-C not adequately controlled wit...
What is the current status of trial NCT02642159?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 413 participants. The study started on 2016-03-15. Estimated completion is 2017-05-15.
What conditions does trial NCT02642159 study?
This clinical trial studies the following conditions: Dyslipidemia.
What interventions are being tested in trial NCT02642159?
The interventions under investigation include: Fenofibrate (DRUG), Ezetimibe (DRUG), Alirocumab (DRUG), Statins (DRUG), Nicotinic acid (DRUG).
Who is sponsoring clinical trial NCT02642159?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02642159 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02642159's enrollment target sits among peer trials
413 8th of 40 higher than 33 of 40 other Dyslipidemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dyslipidemia 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.
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