Phase 3
Completed N=309
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
Source: ClinicalTrials.gov NCT02550288 ↗Enrolled (actual)
309
Serious AEs
0.3%
Results posted
Jun 2017
Primary outcomePrimary: Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 — -19.3; -44.0; -49.1; -55.6 Percentage Change — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Week 12 |
-19.3; -44.0; -49.1; -55.6; -59.2 | <0.001 sig |
| PRIMARY Percentage of Participants Who Experience 1 or More Gastrointestinal-related Adverse Events (AEs) |
5.7; 0.0; 8.7; 7.4; 7.2 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Gallbladder-related AEs |
0.0; 1.5; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs |
0.0; 2.9; 2.9; 0.0; 1.4 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Hepatitis-related AEs |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) ≥3 Times Upper Limit of Normal (ULN) |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in Aspartate Aminotransferase (AST) ≥3 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥3 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in ALT ≥5 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in AST ≥5 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥5 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in ALT ≥10 Times ULN |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in AST ≥10 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants Who Have Consecutive Elevations in ALT and/or AST ≥10 Times ULN |
0.0; 0.0; 0.0; 1.5; 0.0 | — |
| PRIMARY Percentage of Participants With Potential Hy's Law Condition |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Have Elevations in Creatine Kinase (CK) ≥10xULN |
0.0; 0.0; 1.4; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Have Elevations in CK ≥10xULN With Muscle Symptoms |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Have Elevations in CK ≥10xULN and Drug-Related Muscle Symptoms |
0.0; 0.0; 0.0; 0.0; 0.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02550288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.