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HypercholesterolemiaPhase 3I-ROSETTENCT02749994

A Clinical Trial to Compare the Efficacy and Safety of a Combination Therapy of Ezetimibe and Rosuvastatin Versus Monotherapy of Rosuvastatin in Hypercholesterolemia Patients (I-ROSETTE Study)

A Phase 3 study testing Rosuvastatin and Ezetimibe in people with Hypercholesterolemia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients. Read more about this study

Who is it for?
Ages 19 to 79 years
Conditions the study is for
Hypercholesterolemia
What is being tested?
Rosuvastatin and Ezetimibe
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
1 siteSouth Korea
Study dates
Apr 2016to Feb 2017
Phase
Phase 3
Are there results?
None posted in the registry

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 19 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 19 ~ 79 years old
  • Patients who confirmed hypercholesterolemia.
  • Patients who requiring drug therapy according to NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Visit2.
  • Patients with Triglyceride< 400 at Visit 2.
  • Patients who have a wash-out period over 4 weeks for other drugs that can affect lipid profile.(Patients who have lipid regulators should have washout period over six weeks)
  • Patients who agreed to participate in the trial

Who cannot join

  • Patients who have a history of myopathy or rhabdomyolysis by statin treatment or hypersensitivity to statin HMG CoA(3-hydroxy-3-methylglutaryl-coenzyme) reductase inhibitors) or ezetimibe.
  • A heavy alcohol consumer. (alcohol > 25 units/week)
  • Patients with severe renal disease. (creatinine ≥ 2.0 mg/dL)
  • Patients with active liver disease and AST(aspartate transaminase) or ALT(alanine transaminase) > 2 times of upper limit of normal range.
  • Patients with CPK(creatine phosphokinase) > 2 x upper limit of normal range.
  • Patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein.
Show all 16Show fewer
  • Patients with HIV(human immunodeficiency virus positive.
  • Patients who have a acute arteriopathy.
  • Patients with uncontrolled hypertension.
  • Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
  • Patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder.
  • Patients with tumor.
  • Patients who have hormonal therapy.
  • Pregnancy or breastfeeding patients who don't agree to use adequate contraception.
  • Patients who are judged unsuitable to participate in this study by investigator.
  • Patients taking other clinical trial drugs within 30 days from the time of visit for screening.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

A phase Ⅲ, multi-center, randomized, double-blinded, active comparator, factorial design clinical trial to compare the efficacy and safety of a combination therapy of ezetimibe and rosuvastatin versus monotherapy of rosuvastatin in hypercholesterolemia patients.

Being tested
Rosuvastatin, Ezetimibe
Medical subject headings
Hypercholesterolemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02749994
Study groupRoleWhat they receive
R5Active comparatorRosuvastatin 5mg
Receives: Drug: Rosuvastatin
R10Active comparatorRosuvastatin 10mg
Receives: Drug: Rosuvastatin
R20Active comparatorRosuvastatin 20mg
Receives: Drug: Rosuvastatin
R5/E10ExperimentalRosuvastatin 5mg/Ezetimibe 10mg
Receives: Drug: Rosuvastatin; Drug: Ezetimibe
R10/E10ExperimentalRosuvastatin 10mg/Ezetimibe 10mg
Receives: Drug: Rosuvastatin; Drug: Ezetimibe
R20/E10ExperimentalRosuvastatin 20mg/Ezetimibe 10mg
Receives: Drug: Rosuvastatin; Drug: Ezetimibe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent change from baseline to 8 week in LDL-Cholesterol

    Measured: baseline and 8 week

Secondary outcomes (13)

  1. Percent change from baseline to 4 and 8 week in Total Cholesterol

    Measured: baseline to 4 and 8 week

  2. Percent change from baseline to 4 and 8 week in Triglyceride

    Measured: baseline to 4 and 8 week

  3. Percent change from baseline to 4 and 8 week in HDL-Cholesterol

    Measured: baseline to 4 and 8 week

  4. Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol

    Measured: baseline to 4 and 8 week

  5. Percent change from baseline to 4 and 8 week in Apolipoprotein B

    Measured: baseline to 4 and 8 week

  6. Percent change from baseline to 4 and 8 week in Apolipoprotein A1

    Measured: baseline to 4 and 8 week

  7. Percent change from baseline to 4 week in LDL-Cholesterol

    Measured: baseline to 4 week

  8. Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)

    Measured: baseline to 4 and 8

  9. The change of LDL-Cholesterol/HDL-Cholesterol ratio

    Measured: baseline to 4 and 8 week

  10. The change of Total Cholesterol/HDL-Cholesterol ratio

    Measured: baseline to 4 and 8 week

  11. The change of non-HDL-Cholesterol/HDL-Cholesterol ratio

    Measured: baseline to 4 and 8 week

  12. The change of Apolipoprotein B/Apolipoprotein A1 ratio

    Measured: baseline to 4 and 8 week

  13. The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline

    Measured: baseline to 4 and 8 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionFeb 2017
  4. Study completionFeb 2017

Resources

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
Factorial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02749994
Sponsor's protocol ID
ID-ROEZ-302
Acronym
I-ROSETTE
Status last verified
Jun 2018
First submitted
19 Apr 2016
Last updated
13 Jun 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Hong SJ, Jeong HS, Ahn JC, Cha DH, Won KH, Kim W, Cho SK, Kim SY, Yoo BS, Sung KC, Rha SW, Shin JH, Han KR, Chung WS, Hyon MS, Lee HC, Bae JH, Rhee MY, Kwan J, Jeon DW, Yoo KD, Kim HS. A Phase III, Multicenter, Randomized, Double-blind, Active Comparator Clinical Trial to Compare the Efficacy and Safety of Combination Therapy With Ezetimibe and Rosuvastatin Versus Rosuvastatin Monotherapy in Patients With Hypercholesterolemia: I-ROSETTE (Ildong Rosuvastatin & Ezetimibe for Hypercholesterolemia) Randomized Controlled Trial. Clin Ther. 2018 Feb;40(2):226-241.e4. doi: 10.1016/j.clinthera.2017.12.018.

    PubMed 29402522

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rosuvastatin and Ezetimibe in people with Hypercholesterolemia, run by IlDong Pharmaceutical Co Ltd at 1 site in South Korea.

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 6 inclusion and 16 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 13 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percent change from baseline to 8 week in LDL-Cholesterol (time frame: baseline and 8 week). 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 NCT02749994, 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 13 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.

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