- ICH GCP
- US Clinical Trials Registry
- 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)
February 7, 2022 updated by: Organon and Co
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
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
|
EXPERIMENTAL: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Experience at Least 1 Adverse Event (AE)
Time Frame: 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.
|
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
Time Frame: 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.
|
up to 52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time Frame: 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.
|
Baseline (predose) and Week 52
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 18, 2016
Primary Completion (ACTUAL)
December 11, 2017
Study Completion (ACTUAL)
December 11, 2017
Study Registration Dates
First Submitted
April 20, 2016
First Submitted That Met QC Criteria
April 20, 2016
First Posted (ESTIMATE)
April 22, 2016
Study Record Updates
Last Update Posted (ACTUAL)
February 9, 2022
Last Update Submitted That Met QC Criteria
February 7, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Genetic Diseases, Inborn
- Metabolism, Inborn Errors
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Lipid Metabolism, Inborn Errors
- Hyperlipoproteinemias
- Hypercholesterolemia
- Hyperlipoproteinemia Type II
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
- Ezetimibe
Other Study ID Numbers
- 0653H-833
- 163314 (REGISTRY: JAPIC-CTI)
- MK-0653H-833 (OTHER: Merck Study Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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