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

Organon

Status and phase

Completed

Phase 3

Conditions

Hypercholesterolemia

Heterozygous Familial Hypercholesterolemia

Treatments

Drug: EZ 10 mg/Atorva 10 mg FDC

Drug: EZ 10 mg/Atorva 20 mg FDC

Study type

Interventional

Funder types

Industry

Identifiers

NCT02460159

0653C-384

152982 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

135 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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