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)

IlDong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Hypercholesterolemia

Treatments: Drug: Rosuvastatin; Drug: Ezetimibe

Study type: Interventional

Funder types: Industry

Identifiers

NCT02749994

ID-ROEZ-302

Details and patient eligibility

About

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.

Enrollment: 396 patients

Sex: All

Ages: 19 to 79 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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396 participants in 6 patient groups

R5

Active Comparator group

Description:

Rosuvastatin 5mg

Treatment:

Drug: Rosuvastatin

R10

Active Comparator group

Description:

Rosuvastatin 10mg

Treatment:

Drug: Rosuvastatin

R20

Active Comparator group

Description:

Rosuvastatin 20mg

Treatment:

Drug: Rosuvastatin

R5/E10

Experimental group

Description:

Rosuvastatin 5mg/Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin

Drug: Ezetimibe

R10/E10

Experimental group

Description:

Rosuvastatin 10mg/Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin

Drug: Ezetimibe

R20/E10

Experimental group

Description:

Rosuvastatin 20mg/Ezetimibe 10mg

Treatment:

Drug: Rosuvastatin

Drug: Ezetimibe