Clinical trial NCT02749994: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Lead sponsor: IlDong Pharmaceutical Co Ltd
Sponsor class: INDUSTRY
First posted: 2016-04-25
Enrollment: 396
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. 19 \~ 79 years old
2. Patients who confirmed hypercholesterolemia.
3. Patients who requiring drug therapy according to NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Visit2.
4. Patients with Triglyceride\< 400 at Visit 2.
5. 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)
6. Patients who agreed to participate in the trial

Exclusion Criteria:

1. 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.
2. A heavy alcohol consumer. (alcohol \> 25 units/week)
3. Patients with severe renal disease. (creatinine ≥ 2.0 mg/dL)
4. Patients with active liver disease and AST(aspartate transaminase) or ALT(alanine transaminase) \> 2 times of upper limit of normal range.
5. Patients with CPK(creatine phosphokinase) \> 2 x upper limit of normal range.
6. Patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein.
7. Patients with HIV(human immunodeficiency virus positive.
8. Patients who have a acute arteriopathy.
9. Patients with uncontrolled hypertension.
10. Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
11. Patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder.
12. Patients with tumor.
13. Patients who have hormonal therapy.
14. Pregnancy or breastfeeding patients who don't agree to use adequate contraception.
15. Patients who are judged unsuitable to participate in this study by investigator.
16. Patients taking other clinical trial drugs within 30 days from the time of visit for screening.

Primary outcomes:
measure: Percent change from baseline to 8 week in LDL-Cholesterol
timeFrame: baseline and 8 week
Secondary outcomes:
measure: Percent change from baseline to 4 and 8 week in Total Cholesterol
timeFrame: baseline to 4 and 8 week
measure: Percent change from baseline to 4 and 8 week in Triglyceride
timeFrame: baseline to 4 and 8 week
measure: Percent change from baseline to 4 and 8 week in HDL-Cholesterol
timeFrame: baseline to 4 and 8 week
measure: Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol
timeFrame: baseline to 4 and 8 week
measure: Percent change from baseline to 4 and 8 week in Apolipoprotein B
timeFrame: baseline to 4 and 8 week
measure: Percent change from baseline to 4 and 8 week in Apolipoprotein A1
timeFrame: baseline to 4 and 8 week
measure: Percent change from baseline to 4 week in LDL-Cholesterol
timeFrame: baseline to 4 week
measure: Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)
timeFrame: baseline to 4 and 8
measure: The change of LDL-Cholesterol/HDL-Cholesterol ratio
timeFrame: baseline to 4 and 8 week
measure: The change of Total Cholesterol/HDL-Cholesterol ratio
timeFrame: baseline to 4 and 8 week
measure: The change of non-HDL-Cholesterol/HDL-Cholesterol ratio
timeFrame: baseline to 4 and 8 week
measure: The change of Apolipoprotein B/Apolipoprotein A1 ratio
timeFrame: baseline to 4 and 8 week
measure: The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline
timeFrame: baseline to 4 and 8 week
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-soo Kim, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.