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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02748057
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : December 13, 2017
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The study will assess the safety and tolerability of MK-0653H (Ezetimibe 10 mg+ Rosuvastatin 2.5 mg) and MK-0653H (Ezetimibe 10 mg+ Rosuvastatin 5.0 mg) through up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Familial Hypercholesterolemia Drug: Ezetimibe Drug: Rosuvastatin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III, Open-label, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Rosuvastatin Monotherapy
Actual Study Start Date : May 18, 2016
Actual Primary Completion Date : December 11, 2017
Actual Study Completion Date : December 11, 2017

Arm Intervention/treatment
Experimental: Ezetimibe 10 mg + Rosuvastatin 2.5 mg
1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve LDL-C goal after Week 12, dosage of Rosuvastatin may be increased to 5.0 mg
Drug: Ezetimibe
Drug: Rosuvastatin
Experimental: Ezetimibe 10 mg + Rosuvastatin 5.0 mg
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
Drug: Ezetimibe
Drug: Rosuvastatin

Primary Outcome Measures :
  1. Percentage of Participants Who Experience at Least 1 Adverse Event [ Time Frame: up to 54 weeks ]
  2. Percentage of Participants Who are Discontinued from the Study Due to Adverse Event [ Time Frame: up to 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02748057

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Director Merck Sharp & Dohme Corp.

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT02748057     History of Changes
Other Study ID Numbers: 0653H-833
163314 ( Registry Identifier: JAPIC-CTI )
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Hyperlipoproteinemia Type II
Lipid Metabolism Disorders
Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Rosuvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors