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ODYSSEY KT: Alirocumab in High CV Risk Hypercholesterolemia
NCT02289963Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2015
- Primary completion
- Apr 2016
- Countries
- 2
- Sponsor
- Sanofi
- Modality
- Monoclonal Antibodies
- Drugs
- alirocumab
- Conditions
- hypercholesterolemia
01
Overview
Phase 3, randomised, double-blind trial in hypercholesterolemia comparing Alirocumab with Placebo (2 arms). Primary endpoint: Percent Change From Baseline in Calculated LDL-C at 24 weeks. Started Jan 2015; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Alirocumab
Alirocumab 75 mg Q2W (up to 150 mg Q2W) + Stable LMT
Placebo
Placebo Q2W + Stable LMT
03
Who it enrols
Adult patients with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents not adequately controlled with maximally tolerated statin therapy.
04
Endpoints
Primary
Percent Change From Baseline in Calculated LDL-C
Secondary
Percent Change From Baseline in Calculated LDL-C at Week 12
Percent Change From Baseline in Apolipoprotein B
Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol
Percent Change From Baseline in Total Cholesterol
Percent Change From Baseline in Lipoprotein(a)
Percent Change From Baseline in High Density Lipoprotein Cholesterol
Percent Change From Baseline in Fasting Triglycerides
Percent Change From Baseline in Apolipoprotein A-1
05
Results
Primary endpoints met
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