Phase 3
Completed N=135
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-384)
Hypercholesterolemia · Heterozygous Familial Hypercholesterolemia
Source: ClinicalTrials.gov NCT02460159 ↗
Enrolled (actual)
135
Serious AEs
6.7%
Results posted
Jan 2018
Primary outcomePrimary: Percentage of Participants Who Experience 1 or More Adverse Event (AE) — 82.9; 88.9 Percentage of Participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experience 1 or More Adverse Event (AE) |
82.9; 88.9 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs |
30.8; 11.1 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Gallbladder-related AEs |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs |
6.8; 22.2 | — |
| PRIMARY Percentage of Participants Who Experience 1 or More Hepatitis-related AEs |
0.0; 5.6 | — |
| PRIMARY Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 Times Upper Normal Limit (ULN) |
0.9; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Elevations in ALT or AST ≥5 Times ULN |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Elevations in ALT or AST ≥10 Times ULN |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants With Potential Hy's Law Condition |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN With Muscle Symptoms |
0.0; 0.0 | — |
| PRIMARY Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 Times ULN and Drug-Related Muscle Symptoms |
0.0; 0.0 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02460159). 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.