Overview

This trial is active, not recruiting.

Conditions hypercholesterolemia, heterozygous familial hypercholesterolemia
Treatments ez 10 mg/atorva 20 mg fdc, ez 10 mg/atorva 10 mg fdc
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2015
End date February 2017
Trial size 134 participants
Trial identifier NCT02460159, 0653C-384, 152982

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
one EZ 10 mg/Atorva 10 mg fixed-dose combination (FDC) tablet orally with food once daily for 52 weeks.
ez 10 mg/atorva 10 mg fdc MK-0653C
(Experimental)
one EZ 10 mg/Atorva 20 mg fixed -dose combination (FDC) tablet orally with food once daily for 52 weeks.
ez 10 mg/atorva 20 mg fdc MK-0653C

Primary Outcomes

Measure
Percentage of Participants Who Experience 1 or More Adverse Event (AE)
time frame: up to 54 Weeks
Percentage of Participants Who Experience 1 or More Gastrointestinal-related AEs
time frame: up to 54 weeks
Percentage of Participants Who Experience 1 or More Gallbladder-related AEs
time frame: up to 54 weeks
Percentage of Participants Who Experience 1 or More Allergic Reaction or Rash AEs
time frame: up to 54 weeks
Percentage of Participants Who Experience 1 or More Hepatitis-related AEs
time frame: up to 54 weeks
Percentage of Participants Who Experience Consecutive Elevations in Alanine Aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) ≥3 times Upper Normal Limit (ULN)
time frame: up to 52 weeks
Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥5 times ULN
time frame: up to 52 weeks
Percentage of Participants Who Experience Consecutive Elevations in ALT and/or AST ≥10 times ULN
time frame: up to 52 weeks
Percentage of Participants With Potential Hy's Law Condition
time frame: up to 52 weeks
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 times ULN
time frame: up to 52 weeks
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 times ULN with Muscle Symptoms
time frame: up to 52 weeks
Percentage of Participants Who Experience Elevations in Creatine Kinase (CK) ≥10 times ULN and Drug-Related Muscle Symptoms
time frame: up to 52 weeks

Eligibility Criteria

Male or female participants from 20 years up to 80 years old.

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

Additional Information

Official title A Phase III, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653C in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Atorvastatin Calcium Monotherapy
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..