A Study of the Efficacy and Safety of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-832)

Organon

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo for Rosuvastatin; Drug: Ezetimibe 10 mg; Drug: Placebo for Ezetimibe; Drug: Rosuvastatin 2.5 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02741245

0653H-832

163336 (Registry Identifier)

Details and patient eligibility

About

This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (LDL-C) after 12 weeks of treatment.

Enrollment: 321 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese
• Outpatient with hypercholesterolemia
• Female participant who is of reproductive potential has to 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
• Will maintain a stable diet that is consistent with the Japan Atherosclerosis Society Guideline 2012 (JAS 2012) for prevention of atherosclerotic cardiovascular diseases for the duration of the study

Exclusion criteria

• Uncontrolled hypertension (treated or untreated)
• Uncontrolled type 1 or type 2 diabetes mellitus
• History of coronary artery disease (CAD), CAD-equivalent disease
• Familial hypercholesterolemia or has undergone LDL apheresis
• Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
• Has 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
• Currently following an excessive weight reduction diet
• Currently engages 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 Rosuvastatin
• 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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321 participants in 5 patient groups

Ezetimibe 10 mg

Active Comparator group

Description:

1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks

Treatment:

Drug: Placebo for Rosuvastatin

Drug: Ezetimibe 10 mg

Rosuvastatin 2.5 mg

Active Comparator group

Description:

1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.

Treatment:

Drug: Placebo for Rosuvastatin

Drug: Rosuvastatin 2.5 mg

Drug: Placebo for Ezetimibe

Rosuvastatin 5.0 mg

Active Comparator group

Description:

2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.

Treatment:

Drug: Rosuvastatin 2.5 mg

Drug: Placebo for Ezetimibe

Ezetimibe 10 mg+ Rosuvastatin 2.5 mg

Experimental group

Description:

1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.

Treatment:

Drug: Placebo for Rosuvastatin

Drug: Ezetimibe 10 mg

Drug: Rosuvastatin 2.5 mg

Ezetimibe 10 mg+ Rosuvastatin 5.0 mg

Experimental group

Description:

1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.

Treatment:

Drug: Ezetimibe 10 mg

Drug: Rosuvastatin 2.5 mg