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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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R5

Rosuvastatin 5mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

R10

Rosuvastatin 10mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

R20

Rosuvastatin 20mg

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

R5/E10

Rosuvastatin 5mg/Ezetimibe 10mg

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

R10/E10

Rosuvastatin 10mg/Ezetimibe 10mg

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

R20/E10

Rosuvastatin 20mg/Ezetimibe 10mg

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

Interventions

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Rosuvastatin

Intervention Type DRUG

Ezetimibe

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No