Clinical trial NCT02748057: A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
Official title: A Phase III, Open-label, Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Patients With Hypercholesterolemia Who Have Inadequate LDL-C Control on Ezetimibe or Rosuvastatin Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Familial Hypercholesterolemia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2016-04-22
Enrollment: 135
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will assess the safety and tolerability of Ezetimibe 10 mg+ Rosuvastatin 2.5 mg and Ezetimibe 10 mg+ Rosuvastatin 5.0 mg for up to 52 weeks in Japanese participants with hypercholesterolemia uncontrolled with monotherapy of Ezetimibe 10 mg or Rosuvastatin up to 5 mg.


Eligibility criteria: 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
* Homozygous Familial Hypercholesterolemia or has undergone low-density lipoprotein (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

Primary outcomes:
measure: Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
timeFrame: Up to 2 weeks post last dose of study drug (up to 54 weeks)
measure: Percentage of Participants Who Had Study Drug Discontinued Due to an AE
timeFrame: up to 52 weeks
Secondary outcomes:
measure: Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline (predose) and Week 52
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Teramoto T, Yokote K, Nishida C, Oshima N, Takase T. A Phase III Open-label clinical trial to assess the long-term safety of ezetimibe and rosuvastatin combination therapy in Japanese patients with hypercholesterolemia. J Clin Therapeut Med. 2018;34(11):765-82. (in Japanese) https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2018&vo=34&issue=11