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

Phase 3

Completed

• Conditions: Familial Hypercholesterolemia; Hypercholesterolemia
• Interventions: Drug: Ezetimibe; Drug: Rosuvastatin

• Registration Number: NCT02748057
• Lead Sponsor: Organon and Co

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-22
• Study Start: 2016-05-18
• Primary Completion: 2017-12-11
• Study Completion: 2017-12-11
• Results First Submitted: 2018-11-05
• Results First Submitted QC: 2018-11-05
• Results First Posted: 2018-12-04
• Status Verified: 2022-02
• Last Update Submitted: 2024-05-08
• Last Update Posted: 2024-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ezetimibe 10 mg + Rosuvastatin 2.5 mg	Rosuvastatin	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
Ezetimibe 10 mg + Rosuvastatin 5.0 mg	Ezetimibe	1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.
Ezetimibe 10 mg + Rosuvastatin 2.5 mg	Ezetimibe	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
Ezetimibe 10 mg + Rosuvastatin 5.0 mg	Rosuvastatin	1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Had Study Drug Discontinued Due to an AE	up to 52 weeks	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.
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)	Up to 2 weeks post last dose of study drug (up to 54 weeks)	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.

Secondary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)	Baseline (predose) and Week 52	Blood was collected at baseline (predose) and after 52 weeks of treatment to determine LDL-C levels. LDL-C was calculated using the Friedewald equation. If triglycerides (TG) exceeded 400 mg/dL (4.6 mmol/L), LDL-C was determined by beta quantification ultracentrifugation. The percentage change from baseline at Week 52 was summarized.