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)

Phase 3

Completed

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

• Registration Number: NCT02749994
• Lead Sponsor: IlDong Pharmaceutical Co Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-19
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-25
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 396

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
R20	Rosuvastatin	Rosuvastatin 20mg
R20/E10	Rosuvastatin	Rosuvastatin 20mg/Ezetimibe 10mg
R5/E10	Ezetimibe	Rosuvastatin 5mg/Ezetimibe 10mg
R5/E10	Rosuvastatin	Rosuvastatin 5mg/Ezetimibe 10mg
R5	Rosuvastatin	Rosuvastatin 5mg
R10	Rosuvastatin	Rosuvastatin 10mg
R10/E10	Rosuvastatin	Rosuvastatin 10mg/Ezetimibe 10mg
R20/E10	Ezetimibe	Rosuvastatin 20mg/Ezetimibe 10mg
R10/E10	Ezetimibe	Rosuvastatin 10mg/Ezetimibe 10mg

Primary Outcome Measures

Name	Time	Method
Percent change from baseline to 8 week in LDL-Cholesterol	baseline and 8 week

Secondary Outcome Measures

Name	Time	Method
Percent change from baseline to 4 and 8 week in Total Cholesterol	baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in Triglyceride	baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in HDL-Cholesterol	baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol	baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in Apolipoprotein B	baseline to 4 and 8 week
Percent change from baseline to 4 and 8 week in Apolipoprotein A1	baseline to 4 and 8 week
Percent change from baseline to 4 week in LDL-Cholesterol	baseline to 4 week
Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)	baseline to 4 and 8
The change of LDL-Cholesterol/HDL-Cholesterol ratio	baseline to 4 and 8 week
The change of Total Cholesterol/HDL-Cholesterol ratio	baseline to 4 and 8 week
The change of non-HDL-Cholesterol/HDL-Cholesterol ratio	baseline to 4 and 8 week
The change of Apolipoprotein B/Apolipoprotein A1 ratio	baseline to 4 and 8 week
The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline	baseline to 4 and 8 week

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of