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)

Hypercholesterolemia Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Every Four Weeks Treatment Regimen of Alirocumab in Patients With Primary Hypercholesterolemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926782
• Other study ID #: R727-CL-1308
• Status: Completed
• Phase: Phase 3
• First received: August 19, 2013
• Last updated: June 5, 2015
• Start date: October 2013
• Est. completion date: May 2015

Study information

• Verified date: June 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaBulgaria: Bulgarian Drug AgencyHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesIsrael: Ministry of HealthNorway: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if the study drug (alirocumab)administered every 4 weeks, given by injection under the skin is effective and safe compared with placebo in lowering cholesterol, if used alone or added to the participants' current cholesterol-lowering medication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: May 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men and women > age 18 or legal age of majority with elevated LDL-C

2. Patients not having adequate control of their hypercholesterolemia based on their individual level of CVD risk

3. Willing and able to comply with clinic visits and study-related procedures

4. Provide signed informed consent

Exclusion Criteria:

1. Recent (within 3 months prior to the screening visit) myocardial infarction, unstable angina leading to hospitalization, percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), uncontrolled cardiac arrhythmia, stroke, transient ischemic attack, carotid revascularization, endovascular procedure or surgical intervention for peripheral vascular disease

2. Known history of positive test for human immunodeficiency virus (HIV)

3. Any clinically significant abnormality identified at the time of screening that in the judgment of the investigator or any sub-investigator would preclude safe completion of the study or constrain assessment of endpoints, such as major systemic diseases or patients with short life expectancy.

4. Patients considered by the investigator or any sub-investigator to be inappropriate for this study (e.g, geographic or social), actual or anticipated, that the investigator feels would restrict or limit the patient's participation for the duration of the study.

5. Certain laboratory findings obtained during the screening period

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/ exclusion criteria are listed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Alirocumab

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  Bulgaria,  Canada,  Hungary,  Israel,  Norway,  Poland,  Slovakia,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in calculated LDL-C with concomitant statins	The percent change in calculated LDL-C from baseline to week 24 for alirocumab q4w in comparison with placebo after 24 weeks of treatment in patients with hypercholesterolemia at moderate, high, or very high CVD risk who received concomitant statin therapy.	baseline to week 24	No
Primary	Percent change in calculated LDL-C without concomitant statins	The percent change in calculated LDL-C from baseline to week 24 for alirocumab q4w in comparison with placebo after 24 weeks of treatment in patients with hypercholesterolemia who did not receive concomitant statin therapy.	baseline to week 24	No
Secondary	Percent change in calculated LDL-C	The percent change in calculated LDL-C from baseline to week 12	baseline to week 12	No
Secondary	Percent change in ApoB	The percent change in apolipoprotein (Apo) B from baseline to week 24	baseline to week 24	No
Secondary	Percent change in non- HDL-C	The percent change in non-high-density lipoprotein cholesterol (non- HDL-C) from baseline to week 24	baseline to week 24	No
Secondary	Percent change in total cholesterol	The percent change in total cholesterol from baseline to week 24	baseline to week 24	No
Secondary	Percent change in ApoB	The percent change in ApoB from baseline to week 12	baseline to week 12	No
Secondary	Percent change in non-HDL-C	The percent change in non-HDL-C from baseline to week 12	baseline to week 12	No
Secondary	Percent change in total cholesterol	The percent change in total cholesterol from baseline to week 12	baseline to week 12	No
Secondary	Proportion of patients reaching LDL-C goal	The proportion of patients reaching LDL-C goal at week 24	at week 24	No
Secondary	Proportion of patients reaching LDL-C <70 mg/dL	The proportion of patients reaching LDL-C <70 mg/dL at week 24	at week 24	No
Secondary	Proportion of patients reaching LDL-C <100 mg/dL	The proportion of patients reaching LDL-C <100 mg/dL at week 24	at week 24	No
Secondary	Percent change in Lp(a)	The percent change in Lp(a) [lipoprotein (a)] from baseline to week 24	baseline to week 24	No
Secondary	Percent change in HDL-C	The percent change in HDL-C from baseline to week 24	baseline to week 24	No
Secondary	Percent change in Lp(a)	The percent change in Lp(a) from baseline to week 12	baseline to week 12	No
Secondary	Percent change in HDL-C	The percent change in HDL-C from baseline to week 12	baseline to week 12	No
Secondary	Percent change in fasting TG	The percent change in fasting TG (triglycerides) from baseline to week 24	baseline to week 24	No
Secondary	Percent change in ApoA-1	The percent change in ApoA-1 from baseline to week 24	baseline to week 24	No
Secondary	Percent change in fasting TG	The percent change in fasting TG from baseline to week 12	baseline to week 12	No
Secondary	Percent change in ApoA-1	The percent change in ApoA-1 from baseline to week 12	baseline to week 12	No