Trial record 2 of 5 for:    mk-0653c

A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02550288
First received: September 14, 2015
Last updated: June 7, 2016
Last verified: June 2016
  Purpose
This study will evaluate the efficacy and safety of MK-0653C (Ezetimibe [EZ] 10 mg/Atorvastatin [Atora] 10mg or 20 mg) compared to EZ 10 mg, Atora 10 mg, or Atora 20 mg alone when administered to Japanese participants with hypercholesterolemia. The primary hypothesis is that MK-0653C (EZ 10 mg/Atorva 10 mg) is superior to EZ 10 mg and is superior to Atorva 10 mg and that MK-0653C (EZ 10 mg/Atorva 20 mg) is superior to EZ 10 mg and is superior to Atorva 20 mg in percent change from baseline in low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment.

Condition Intervention Phase
Hypercholesterolemia
Drug: Ezetimibe 10 mg
Drug: Atorvastatin 10 mg
Drug: Placebo for Ezetimibe 10 mg tablet
Drug: Placebo for Atorvastatin 10 mg capsule
Behavioral: Diet control/Daily Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Active Comparator-controlled Clinical Trial to Study the Efficacy and Safety of MK-0653C in Japanese Patients With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Percent Change from Baseline in LDL-C at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs) [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience 1 or More Gallbladder-related AEs [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience 1 or More Hepatitis-related AEs [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 times Upper Normal Limit (ULN) [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 times ULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants With Potential Hy's Law Condition [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Have Elevations in CK ≥10xULN with Muscle Symptomss [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]
  • Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms [ Time Frame: up to 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 309
Study Start Date: September 2015
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ezetimibe 10 mg
1 ezetimide 10 mg tablet, 2 atorvastatin 10 mg placebo capsules orally once daily for 12 weeks.
Drug: Ezetimibe 10 mg Drug: Placebo for Atorvastatin 10 mg capsule Behavioral: Diet control/Daily Exercise
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
Active Comparator: Atorvastatin 10 mg
1 atorvastatin 10 mg capsule, 1 ezetimide 10 mg placebo tablet, and 1 atorvastatin 10 mg placebo capsule orally once daily for 12 weeks.
Drug: Atorvastatin 10 mg Drug: Placebo for Ezetimibe 10 mg tablet Drug: Placebo for Atorvastatin 10 mg capsule Behavioral: Diet control/Daily Exercise
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
Active Comparator: Atorvastatin 20 mg
2 atorvastatin 10 mg capsules and 1 ezetimide 10 mg placebo tablet orally, once daily for 12 weeks.
Drug: Atorvastatin 10 mg Drug: Placebo for Ezetimibe 10 mg tablet Behavioral: Diet control/Daily Exercise
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
Experimental: Ezetimibe 10 mg + Atorvastatin 10 mg
1 Ezetimibe 10 mg tablet, 1 atorvastatin 10 mg capsule and 1 atorvastatin 10 mg placebo capsule orally, once daily for 12 weeks
Drug: Ezetimibe 10 mg Drug: Atorvastatin 10 mg Drug: Placebo for Atorvastatin 10 mg capsule Behavioral: Diet control/Daily Exercise
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
Experimental: Ezetimibe 10 mg +Atorvastatin 20 mg
1 Ezetimibe 10 mg tablet and 2 atorvastatin 10 mg capsules orally, once daily for 12 weeks
Drug: Ezetimibe 10 mg Drug: Atorvastatin 10 mg Behavioral: Diet control/Daily Exercise
Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Japanese outpatient with hypercholesterolemia.
  • Females must be 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 Japan Atherosclerosis Society Guideline 2012 (JAS2012) 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)
  • History of coronary artery disease (CAD) 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02550288

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02550288     History of Changes
Other Study ID Numbers: 0653C-383  153060 
Study First Received: September 14, 2015
Last Updated: June 7, 2016
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2016