A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)

NCT ID: NCT02460159

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-23
• Study Completion Date: 2016-12-22

Brief Summary

This study will assess the safety and tolerability of Ezetimibe (EZ) 10 mg/Atorvastatin (Atora) 10 mg and EZ 10mg/Atora 20 mg fixed-dose combination (FDC) in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Atorvastatin up to 20 mg. There is no formal hypothesis for the study.

Conditions

Hypercholesterolemia; Heterozygous Familial Hypercholesterolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EZ 10 mg/Atorva 10 mg FDC

one EZ 10 mg/Atorva 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.

Group Type: EXPERIMENTAL

EZ 10 mg/Atorva 10 mg FDC

Intervention Type: DRUG

EZ 10 mg/Atorva 20 mg FDC

one EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.

Group Type: EXPERIMENTAL

EZ 10 mg/Atorva 20 mg FDC

Intervention Type: DRUG

Interventions

EZ 10 mg/Atorva 20 mg FDC

Intervention Type: DRUG

EZ 10 mg/Atorva 10 mg FDC

Intervention Type: DRUG

Other Intervention Names

MK-0653C; MK-0653C

Eligibility Criteria

Inclusion Criteria

• Japanese
• Outpatient with hypercholesterolemia
• Has familial hypercholesterolemia (FH) diagnosed per genetic testing or meets two or more of the below criteria based on Japan Atherosclerosis Society Guideline 2012 (JAS2012): Hyper low-density lipoprotein (LDL)-cholesterolemia (an untreated LDL-C level of ≥180mg/dL); tendon xanthoma (tendon xanthoma on the backs of the hands, elbows, knees, etc. or achilles tendon hypertrophy) or xanthoma tuberosum; family history of FH or premature coronary arterial disease (within the participant's second degree relatives)
• Females must be of 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 JAS 2012 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)
• 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 A, Oshima N, Takase T, Hirano T. A Phase III open-label clinical trial to assess the long-term safety of ezetimibe and atorvastatin combination therapy in Japanese patients with hypercholesterolemia. J Clin Therapeut Med. 2017;33(8):655-670.

Reference Type: RESULT

Other Identifiers

152982

Identifier Type: REGISTRY

Identifier Source: secondary_id

0653C-384

Identifier Type: -

Identifier Source: org_study_id