Evaluation of Alirocumab in Addition to Lipid-Modifying Therapy in Patients With High Cardiovascular Risk and Hypercholesterolemia in South Korea and Taiwan

NCT ID: NCT02289963

Last Updated: 2017-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-04-30

Brief Summary

Primary Objective:

To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan.

Secondary Objectives:

• To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
• To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp [a]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1).
• To evaluate the safety and tolerability of alirocumab.
• To evaluate the development of anti-alirocumab antibodies (ADA).

Detailed Description

The maximum study duration was approximately 35 weeks per participant, including up to 3 weeks screening period, 24 weeks double-blind treatment period, and 8 weeks follow-up period.

Conditions

Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo Q2W

Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo (for Alirocumab)

Intervention Type: DRUG

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Lipid-Modifying Therapy (LMT)

Intervention Type: DRUG

Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Group Type: PLACEBO_COMPARATOR

Alirocumab

Intervention Type: DRUG

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Lipid-Modifying Therapy (LMT)

Intervention Type: DRUG

Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.

Interventions

Placebo (for Alirocumab)

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Intervention Type: DRUG

Alirocumab

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Intervention Type: DRUG

Lipid-Modifying Therapy (LMT)

Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.

Intervention Type: DRUG

Other Intervention Names

SAR236553; REGN727; Praluent®

Eligibility Criteria

Inclusion Criteria

Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3).

Exclusion Criteria

• Aged <18 years or legal age of adulthood, whichever was greater.
• Participants without established CHD or CHD risk equivalent.
• LDL-C <70 mg/dL (<1.81 mmol/L) in participants with a history of documented cardiovascular disease.
• LDL-C <100 mg/dL (<2.59 mmol/L) in participants without a history of documented cardiovascular disease.
• Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits.
• Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin.
• Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose.
• Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg.
• Fasting serum triglycerides >400 mg/dL (>4.52 mmol/L) at the screening period.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 410001

Anyang, , South Korea

Investigational Site Number 410009

Anyang-si, , South Korea

Investigational Site Number 410017

Busan, , South Korea

Investigational Site Number 410007

Busan, , South Korea

Investigational Site Number 410002

Daegu, , South Korea

Investigational Site Number 410011

Goyang-si, , South Korea

Investigational Site Number 410003

Gwangju, , South Korea

Investigational Site Number 410012

Incheon, , South Korea

Investigational Site Number 410018

Jeonju, , South Korea

Investigational Site Number 410006

Seoul, , South Korea

Investigational Site Number 410004

Seoul, , South Korea

Investigational Site Number 410015

Seoul, , South Korea

Investigational Site Number 410008

Seoul, , South Korea

Investigational Site Number 410005

Seoul, , South Korea

Investigational Site Number 410010

Seoul, , South Korea

Investigational Site Number 410013

Ulsan, , South Korea

Investigational Site Number 158007

Changhua, , Taiwan

Investigational Site Number 158005

Hsinchu, , Taiwan

Investigational Site Number 158011

Kaohsiung City, , Taiwan

Investigational Site Number 158010

Kaohsiung City, , Taiwan

Investigational Site Number 158006

Taichung, , Taiwan

Investigational Site Number 158008

Tainan City, , Taiwan

Investigational Site Number 158009

Tainan Hsien, , Taiwan

Investigational Site Number 158001

Taipei, , Taiwan

Investigational Site Number 158003

Taipei, , Taiwan

Investigational Site Number 158002

Taipei, , Taiwan

Investigational Site Number 158004

Taoyuan Hsien, , Taiwan

Countries

South Korea; Taiwan

References

Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

Reference Type: DERIVED

PMID: 33078867 (View on PubMed)

Chao TH, Hsiao PJ, Liu ME, Wu CJ, Chiang FT, Chen ZC, Chen CP, Yeh HI, Lee TH, Chiang CE. A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab. J Chin Med Assoc. 2019 Apr;82(4):265-271. doi: 10.1097/JCMA.0000000000000062.

Reference Type: DERIVED

PMID: 30946207 (View on PubMed)

Koh KK, Nam CW, Chao TH, Liu ME, Wu CJ, Kim DS, Kim CJ, Li I, Li J, Baccara-Dinet MT, Hsiao PJ, Chiang CE. A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT). J Clin Lipidol. 2018 Jan-Feb;12(1):162-172.e6. doi: 10.1016/j.jacl.2017.09.007. Epub 2017 Oct 19.

Reference Type: DERIVED

PMID: 29153823 (View on PubMed)

Other Identifiers

U1111-1157-3294

Identifier Type: OTHER

Identifier Source: secondary_id

EFC14074

Identifier Type: -

Identifier Source: org_study_id