HypercholesterolemiaPhase 3NCT02748057
A Clinical Trial to Assess the Long Term Safety and Tolerability of MK-0653H in Japanese Participants With Hypercholesterolemia (MK-0653H-833)
A Phase 3 study testing Ezetimibe and Rosuvastatin in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Organon and Co.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Hypercholesterolemia, Familial Hypercholesterolemia
- What is being tested?
- Ezetimibe and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 18 May 2016to 11 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
About this study
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
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.
- Being tested
- Ezetimibe, Rosuvastatin
- Medical subject headings
- Hypercholesterolemia, Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
RosuvastatinDrug
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Ezetimibe; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 52 weeks
Secondary outcomes (1)
Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
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.
Measured: Baseline (predose) and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start18 May 2016
- Primary completion11 Dec 2017
- Study completion11 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748057
- Sponsor's protocol ID
- 0653H-833
- Other IDs
- 163314, MK-0653H-833
- Status last verified
- Feb 2022
- First submitted
- 20 Apr 2016
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02748057
- Acronym / sponsor ID
- 0653H-833
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- 18 May 2016 (actual)
- Primary completion
- 11 Dec 2017 (actual)
- Study completion
- 11 Dec 2017 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Posted 4 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe 10 mg + Rosuvastatin 2.5 mg | Experimental | Drug: Ezetimibe, Drug: Rosuvastatin1 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 | Experimental | Drug: Ezetimibe, Drug: Rosuvastatin1 Ezetimibe 10 mg tablet and 2 Rosuvastatin 2.5 mg capsules/tablets orally, once daily for 52 weeks. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
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.
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.
1 secondary outcome
Percentage Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C)
Time frame: Baseline (predose) and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationTeramoto 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ezetimibe and Rosuvastatin in people with Hypercholesterolemia and Familial Hypercholesterolemia, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748057, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.