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

NCT02748057 | Completed Phase 3 Results

• 3 other identifiers: 0653H-833163314MK-0653H-833
• Study Type: interventional
• Target: 135
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Who Experience at Least 1 Adverse Event (AE)

  An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who reported at least 1 AE was summarized.

  Up to 2 weeks post last dose of study drug (up to 54 weeks)

• Percentage of Participants Who Had Study Drug Discontinued Due to an AE

  An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, regardless of whether or not it was considered related to the medicinal product. The percentage of participants who had study drug discontinued due to an AE was summarized.

  up to 52 weeks

Secondary Outcomes (1)

• Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)

  Baseline (predose) and Week 52

Study Arms (2)

Ezetimibe 10 mg + Rosuvastatin 2.5 mg

EXPERIMENTAL

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

Drug: Ezetimibe; Drug: Rosuvastatin

Ezetimibe 10 mg + Rosuvastatin 5.0 mg

EXPERIMENTAL

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

Drug: Ezetimibe; Drug: Rosuvastatin

Interventions

Ezetimibe DRUG

Ezetimibe 10 mg + Rosuvastatin 2.5 mg; Ezetimibe 10 mg + Rosuvastatin 5.0 mg

Rosuvastatin DRUG

Ezetimibe 10 mg + Rosuvastatin 2.5 mg; Ezetimibe 10 mg + Rosuvastatin 5.0 mg

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipoproteinemia Type II

Interventions

Ezetimibe; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: May 18, 2016
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: May 16, 2024
• Results First Posted: December 4, 2018

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share