Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab (REGN727/ SAR236553) in Patients With Primary Hypercholesterolemia (ODYSSEY CHOICE 1)

Conditions

• Hypercholesterolemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo (for alirocumab) — DRUG
  Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
• Alirocumab — DRUG
  Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
• Statin — DRUG
  Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy

Study Details

To determine the efficacy, long-term safety, and tolerability of alirocumab 300 mg every 4 weeks (Q4W), in comparison with placebo, as well as its potential as a starting regimen. The dose regimen of 75 mg every 2 weeks (Q2W), as used in other studies, was added as a calibrator.

Key Dates

Start date

Sep 30, 2013

Status verified

Jan 2017

Primary completion

Sep 30, 2014

Completion

Apr 30, 2015

Study Design

Enrollment

803 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo Q2W
  Two subcutaneous (SC) injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
• Experimental: Alirocumab 75 mg/ Up 150 mg Q2W
  One SC injection of each Alirocumab 75 mg and placebo Q2W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.
• Experimental: Alirocumab 300 mg/ Up 150 mg Q4W
  Two SC injections of Alirocumab 150 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk participants) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk participants) at Week 8.

Primary Outcome Measure

Percent Change From Baseline in Calculated LDL-C in Participants Not Receiving Concomitant Statin Therapy - ITT Analysis [ Time Frame: From Baseline to Week 24 ]

Locations (49)

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