A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)

NCT ID: NCT02748057

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 135 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-18
• Study Completion Date: 2017-12-11

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.

Conditions

Hypercholesterolemia; Familial Hypercholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ezetimibe 10 mg + Rosuvastatin 2.5 mg

1 Ezetimibe 10 mg tablet and 1 Rosuvastatin 2.5 mg capsule/tablet orally, once daily for 52 weeks. If participant does not achieve low-density lipoprotein- cholesterol (LDL-C) goal after Week 12, dosage of Rosuvastatin may be increased to 5.0 mg

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

Ezetimibe 10 mg + Rosuvastatin 5.0 mg

1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.

Group Type: EXPERIMENTAL

Ezetimibe

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

Interventions

Ezetimibe

Intervention Type: DRUG

Rosuvastatin

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

163314

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-0653H-833

Identifier Type: OTHER

Identifier Source: secondary_id

0653H-833

Identifier Type: -

Identifier Source: org_study_id