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

NCT ID: NCT02741245

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-09
• Study Completion Date: 2017-01-18

Brief Summary

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.

Conditions

Hypercholesterolemia

Study Design

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

Study Groups

Ezetimibe 10 mg

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

Group Type: ACTIVE_COMPARATOR

Ezetimibe 10 mg

Intervention Type: DRUG

Placebo for Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 2.5 mg

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

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 2.5 mg

Intervention Type: DRUG

Placebo for Ezetimibe

Intervention Type: DRUG

Placebo for Rosuvastatin

Intervention Type: DRUG

Rosuvastatin 5.0 mg

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

Group Type: ACTIVE_COMPARATOR

Rosuvastatin 2.5 mg

Intervention Type: DRUG

Placebo for Ezetimibe

Intervention Type: DRUG

Ezetimibe 10 mg+ Rosuvastatin 2.5 mg

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

Group Type: EXPERIMENTAL

Ezetimibe 10 mg

Intervention Type: DRUG

Rosuvastatin 2.5 mg

Intervention Type: DRUG

Placebo for Rosuvastatin

Intervention Type: DRUG

Ezetimibe 10 mg+ Rosuvastatin 5.0 mg

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

Group Type: EXPERIMENTAL

Ezetimibe 10 mg

Intervention Type: DRUG

Rosuvastatin 2.5 mg

Intervention Type: DRUG

Interventions

Ezetimibe 10 mg

Intervention Type: DRUG

Rosuvastatin 2.5 mg

Intervention Type: DRUG

Placebo for Ezetimibe

Intervention Type: DRUG

Placebo for Rosuvastatin

Intervention Type: DRUG

Eligibility Criteria

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

• 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, Oshima N, Takase T. A phase III clinical trial to study the efficacy and safety of ezetimibe plus rosuvastatin combination therapy in Japanese patients with hypercholesterolemia - A randomized, double-blind comparative study. J Clin Therapeut Med. 2017;33(11):881-896.

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

163336

Identifier Type: REGISTRY

Identifier Source: secondary_id

0653H-832

Identifier Type: -

Identifier Source: org_study_id