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Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin
Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin

NCT02584504

CompletedPhase 3

Sponsor: Sanofi

Conditions: Hypercholesterolemia

Interventions: Alirocumab, Placebo, Atorvastatin, Non-statin Lipid-Modifying Therapy, Diet Alone

Countries: Japan

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab administration as add-on therapy to non-statin lipid modifying therapy (LMT) including diet therapy alone or the lowest strength of statin in comparison with placebo after 12 weeks of treatment in participants with hypercholesterolemia. Secondary Objective: * To evaluate the effect of two treatment regimens 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), triglyceride (TG), and apolipoprotein A-1 (Apo A-1). * To evaluate the safety and tolerability of alirocumab administration. * To evaluate the development of anti-alirocumab antibodies. * To evaluate the pharmacokinetic and pharmacodynamic profiles of alirocumab administration. * To evaluate the long-term safety in participants receiving open-label alirocumab administration.

Eligibility overview

Sex: ALL

Age: 20 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria :

Participants with hypercholesterolemia (heFH or non-FH) receiving non statin LMTs or the lowest strength of statin.

Exclusion criteria:

* LDL-C \<100 mg/dL (\<2.59 mmol/L) at the screening visit (Week -3) in participants with heFH or in participants with non-FH who have a history of documented coronary heart disease.
* LDL-C \<120 mg/dL (\<3.10 mmol/L) at the screening visit (Week -3) in participants with non-FH participants who had a history of documented diseases or other risk factors classified as primary prevention category III as defined in JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
* Not on a stable dose of LMT (including diet therapy alone) in the run-in period or the screening period.
* Fasting serum TGs \>400 mg/dL (\>4.52 mmol/L) at the screening period.
* Systolic blood pressure (BP) \>160 mmHg or diastolic BP \>100 mmHg at the run-in visit (Week -7) or the screening visit (Week -3) or the randomization visit (Week 0).

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Locations (30)
  • Ageo-Shi, Japan
  • Chūōku, Japan
  • Chūōku, Japan
  • Fukui-shi, Japan
  • Hachioji-Shi, Japan
  • Itoshima-Shi, Japan
  • Kanazawa, Japan
  • Kasuga-Shi, Japan
  • Kawanishi-Shi, Japan
  • Kitakyushu-Shi, Japan
  • Komatsu-Shi, Japan
  • Matsudo-Shi, Japan
  • Matsumoto-Shi, Japan
  • Mito, Japan
  • Morioka, Japan
  • Moriya-Shi, Japan
  • Nagoya, Japan
  • Nagoya, Japan
  • Nagoya, Japan
  • Nagoya, Japan
  • Osaka, Japan
  • Sakura-Shi, Japan
  • Shinagawa-Ku, Japan
  • Shinjuku-Ku, Japan
  • Shinjuku-Ku, Japan
  • Shizuoka, Japan
  • Suita-Shi, Japan
  • Suita-Shi, Japan
  • Toyonaka-Shi, Japan
  • Yakushi, Japan