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

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo for Ezetimibe 10 mg tablet; Behavioral: Diet control/Daily Exercise; Drug: Ezetimibe 10 mg; Drug: Atorvastatin 10 mg; Drug: Placebo for Atorvastatin 10 mg capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT02550288

0653C-383

153060 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 309 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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309 participants in 5 patient groups

Ezetimibe 10 mg

Active Comparator group

Description:

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

Treatment:

Drug: Ezetimibe 10 mg

Behavioral: Diet control/Daily Exercise

Drug: Placebo for Atorvastatin 10 mg capsule

Atorvastatin 10 mg

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin 10 mg

Drug: Placebo for Ezetimibe 10 mg tablet

Behavioral: Diet control/Daily Exercise

Drug: Placebo for Atorvastatin 10 mg capsule

Atorvastatin 20 mg

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin 10 mg

Drug: Placebo for Ezetimibe 10 mg tablet

Behavioral: Diet control/Daily Exercise

Ezetimibe 10 mg + Atorvastatin 10 mg

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin 10 mg

Drug: Ezetimibe 10 mg

Behavioral: Diet control/Daily Exercise

Drug: Placebo for Atorvastatin 10 mg capsule

Ezetimibe 10 mg + Atorvastatin 20 mg

Experimental group

Description:

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

Treatment:

Drug: Atorvastatin 10 mg

Drug: Ezetimibe 10 mg

Behavioral: Diet control/Daily Exercise