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

NCT02289963

CompletedPhase 3

Sponsor: Sanofi

Conditions: Hypercholesterolemia

Interventions: Placebo (for Alirocumab), Alirocumab, Lipid-Modifying Therapy (LMT)

Countries: South Korea, Taiwan

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (27)

Anyang, South Korea
Anyang-si, South Korea
Busan, South Korea
Busan, South Korea
Daegu, South Korea
Goyang-si, South Korea
Gwangju, South Korea
Incheon, South Korea
Jeonju, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Seoul, South Korea
Ulsan, South Korea
Changhua, Taiwan
Hsinchu, Taiwan
Kaohsiung City, Taiwan
Kaohsiung City, Taiwan
Taichung, Taiwan
Tainan, Taiwan
Tainan Hsien, Taiwan
Taipei, Taiwan
Taipei, Taiwan
Taipei, Taiwan
Taoyuan Hsien, Taiwan