A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)

NCT ID: NCT02550288

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 309 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-29
• Study Completion Date: 2016-05-30

Brief Summary

This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10 mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.

Conditions

Hypercholesterolemia

Study Design

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

Study Groups

Ezetimibe 10 mg

1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Ezetimibe 10 mg

Intervention Type: DRUG

Placebo for Atorvastatin 10 mg capsule

Intervention Type: DRUG

Diet control/Daily Exercise

Intervention Type: BEHAVIORAL

Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Atorvastatin 10 mg

1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Atorvastatin 10 mg

Intervention Type: DRUG

Placebo for Ezetimibe 10 mg tablet

Intervention Type: DRUG

Placebo for Atorvastatin 10 mg capsule

Intervention Type: DRUG

Diet control/Daily Exercise

Intervention Type: BEHAVIORAL

Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Atorvastatin 20 mg

2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Atorvastatin 10 mg

Intervention Type: DRUG

Placebo for Ezetimibe 10 mg tablet

Intervention Type: DRUG

Diet control/Daily Exercise

Intervention Type: BEHAVIORAL

Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Ezetimibe 10 mg + Atorvastatin 10 mg

1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks

Group Type: EXPERIMENTAL

Ezetimibe 10 mg

Intervention Type: DRUG

Atorvastatin 10 mg

Intervention Type: DRUG

Placebo for Atorvastatin 10 mg capsule

Intervention Type: DRUG

Diet control/Daily Exercise

Intervention Type: BEHAVIORAL

Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Ezetimibe 10 mg + Atorvastatin 20 mg

1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks

Group Type: EXPERIMENTAL

Ezetimibe 10 mg

Intervention Type: DRUG

Atorvastatin 10 mg

Intervention Type: DRUG

Diet control/Daily Exercise

Intervention Type: BEHAVIORAL

Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Interventions

Ezetimibe 10 mg

Intervention Type: DRUG

Atorvastatin 10 mg

Intervention Type: DRUG

Placebo for Ezetimibe 10 mg tablet

Intervention Type: DRUG

Placebo for Atorvastatin 10 mg capsule

Intervention Type: DRUG

Diet control/Daily Exercise

Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Japanese outpatient with hypercholesterolemia.
• Females must be non-reproductive potential or agree to remain abstinent or use (or partner use) two acceptable methods of birth control from date of signed informed consent to the 14 days after the last dose of study drug
• Agree to maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion Criteria

• Uncontrolled hypertension
• Type 1 or uncontrolled type 2 diabetes mellitus (treated or untreated)
• History of coronary artery disease (CAD) Homozygous familial hypercholesterolemia or has undergone LDL apheresis
• Had a gastrointestinal tract bypass, or other significant intestinal malabsorption
• History of cancer within the past 5 years except for successfully treated dermatological basal cell or squamous cell carcinoma or in situ cervical cancer
• Human immunodeficiency virus (HIV) positive
• History of drug/ alcohol abuse within the past 5 years or psychiatric illness not adequately controlled and stable on pharmacotherapy
• Consumes more than 25 g of alcohol per day
• Consumes more than 1L of grapefruit juice per day
• Currently following an excessive weight reduction diet
• Engaging in a vigorous exercise regimen (e.g.; marathon training, body building training etc.) or intends to start training during the study
• Hypersensitivity or intolerance to ezetimibe or atorvastatin
• History of myopathy or rhabdomyolysis with ezetimibe or any statin
• Pregnant or lactating
• Taking any other investigational drugs and/or has taken any investigational drugs within 30 days

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

Teramoto T, Yokote K, Nishida C, Tershakovec AM, Oshima N, Takase T, Hirano T, Lee R, Johnson-Levonas AO. A phase III, clinical trial to study the efficacy and tolerability of ezetimibe plus atorvastatin combination therapy in Japanese patients with hypercholesterolemia: a randomized, double-blind comparative study. J Clin Therapeut Med. 2017;33(7):551-567

Reference Type: RESULT

Other Identifiers

153060

Identifier Type: REGISTRY

Identifier Source: secondary_id

0653C-383

Identifier Type: -

Identifier Source: org_study_id