A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

• Status: Completed
• Trial end date: 2017-12-11
• Target enrollment: 0
• Participant gender: All

Summary

The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Ezetimibe; Rosuvastatin Calcium

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

• Homozygous Familial Hypercholesterolemia or has undergone low-density lipoprotein (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