Overview

This trial is active, not recruiting.

Condition hypercholesterolemia
Treatments ezetimibe 10 mg, rosuvastatin 2.5 mg, placebo for ezetimibe, placebo for rosuvastatin
Phase phase 3
Sponsor Merck Sharp & Dohme Corp.
Start date June 2016
End date January 2017
Trial size 306 participants
Trial identifier NCT02741245, 0653H-832, 163336

Summary

This study will evaluate the efficacy and safety and tolerability of 2 dose levels of MK-0653H in Japanese participants. The primary hypotheses are that the administration of MK-0653H is safe and tolerable and that MK-0653H is superior to single entity of Ezetimibe and Rosuvastatin in percent reduction from baseline in low-density lipoprotein-cholesterol (LDL-C) after 12 weeks of treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
1 Ezetimibe 10 mg tablet and 2 Rosuvastatin placebo capsules once daily for 12 weeks
ezetimibe 10 mg
placebo for rosuvastatin
(Active Comparator)
1 Rosuvastatin 2.5 mg capsule, 1 Rosuvastatin placebo capsule and 1 Ezetimibe placebo tablet once daily for 12 weeks.
rosuvastatin 2.5 mg
placebo for ezetimibe
placebo for rosuvastatin
(Active Comparator)
2 Rosuvastatin 2.5 mg capsules and Ezetimibe placebo tablet once daily for 12 weeks.
rosuvastatin 2.5 mg
placebo for ezetimibe
(Experimental)
1 Ezetimbie 10 mg tablet, 1 Rosuvastatin 2.5 mg capsule and 1 Rosuvastatin placebo capsule once daily for 12 weeks.
ezetimibe 10 mg
rosuvastatin 2.5 mg
placebo for rosuvastatin
(Experimental)
1 Ezetimbie 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules once daily for 12 weeks.
ezetimibe 10 mg
rosuvastatin 2.5 mg

Primary Outcomes

Measure
Percentage Change From Baseline in LDL-C
time frame: Baseline and Week 12
Percentage of Participants Who Experience at Least 1 Adverse Event
time frame: up to 14 weeks
Percentage of Participants Who are Discontinued from the Study Due to Adverse Event
time frame: up to 12 weeks

Eligibility Criteria

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

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 - History of coronary artery disease (CAD), CAD-equivalent disease - Familial hypercholesterolemia or has undergone 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

Additional Information

Official title A Phase III, Randomized, Active Comparator-controlled, Clinical Trial to Study the Efficacy and Safety of MK-0653H in Japanese Patients With Hypercholesterolemia.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..