Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01644188
• Date of registration: 16/07/2012
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Efficacy and Safety of Alirocumab (SAR236553/REGN727) Versus Ezetimibe on Top of Statin in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY COMBO II)
• Scientific title: A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 Versus Ezetimibe in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Statin Therapy
• Date of first enrolment: August 2012
• Target sample size: 720
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01644188
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Canada, Denmark, France, Hungary, Israel, Korea, Republic of, Russian Federation, South Africa, Ukraine, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD
risk equivalents who were not adequately controlled with a maximally tolerated daily dose
of statin at stable dose for at least 4 weeks prior to the screening visit (Week -2).

Exclusion criteria:

- Age < 18 or legal age of adulthood, whichever was greater

- Participants without established CHD or CHD risk equivalents

- LDL-C <70 mg/dL (<1.81 mmol/L) and participants with a history of documented
cardiovascular disease

- LDL-C <100 mg/dL (<2.59 mmol/L) and participants without a history of documented CV
disease

- Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L)

The above information was not intended to contain all considerations relevant to a
participant's potential participation in a clinical trial.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hypercholesterolemia

Intervention(s)

Drug: Ezetimibe

Drug: Lipid Modifying Therapy (LMT)

Drug: Alirocumab

Drug: Placebo (for alirocumab)

Drug: Placebo (for ezetimibe)

Primary Outcome(s)

Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-treat (ITT) Analysis [Time Frame: From Baseline to Week 52]

Secondary Outcome(s)

Percent Change From Baseline in Apolipoprotein A-1 (Apo A-1) at Week 24 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Apo B at Week 24 - On-Treatment Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Apo-B at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 24 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Calculated LDL--C at Week 24 - On--Treatment Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in HDL-C at Week 24 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Lipoprotein(a) at Week 24 - ITT Analysis [Time Frame: From baseline to Week 52]

Percent Change From Baseline in HDL-C at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Lipoprotein(a) at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Apolipoprotein B (Apo-B) at Week 24 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - ITT Analysis [Time Frame: Up to Week 52]

Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 24 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Apo A-1 at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Non-HDL-C at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percentage of Participants Achieving Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 24 - On-Treatment Analysis [Time Frame: Up to Week 52]

Percent Change From Baseline in Calculated LDL-C at Week 52 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Fasting Triglycerides at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Non-HDL-C at Week 24 - On-Treatment Analysis [Time Frame: From Baseline up to Week 52]

Percent Change From Baseline in Total-C at Week 12 - ITT Analysis [Time Frame: From Baseline to Week 52]

Percent Change From Baseline in Fasting Triglycerides at Week 24 - ITT Analysis [Time Frame: From Baseline to Week 52]

Secondary ID(s)

EFC11569

2011-004130-34

U1111-1121-4315

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Regeneron Pharmaceuticals

Results

• Results available: Yes
• Date Posted: 06/11/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01644188