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)

Hypercholesterolemia Clinical Trial

— I-ROSETTE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02749994
• Other study ID #: ID-ROEZ-302
• Status: Completed
• Phase: Phase 3
• Start date: April 2016
• Est. completion date: February 2017

Study information

• Verified date: June 2018
• Source: IlDong Pharmaceutical Co Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Rosuvastatin

• Ezetimibe

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
IlDong Pharmaceutical Co Ltd

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to 8 week in LDL-Cholesterol		baseline and 8 week
Secondary	Percent change from baseline to 4 and 8 week in Total Cholesterol		baseline to 4 and 8 week
Secondary	Percent change from baseline to 4 and 8 week in Triglyceride		baseline to 4 and 8 week
Secondary	Percent change from baseline to 4 and 8 week in HDL-Cholesterol		baseline to 4 and 8 week
Secondary	Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol		baseline to 4 and 8 week
Secondary	Percent change from baseline to 4 and 8 week in Apolipoprotein B		baseline to 4 and 8 week
Secondary	Percent change from baseline to 4 and 8 week in Apolipoprotein A1		baseline to 4 and 8 week
Secondary	Percent change from baseline to 4 week in LDL-Cholesterol		baseline to 4 week
Secondary	Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)		baseline to 4 and 8
Secondary	The change of LDL-Cholesterol/HDL-Cholesterol ratio		baseline to 4 and 8 week
Secondary	The change of Total Cholesterol/HDL-Cholesterol ratio		baseline to 4 and 8 week
Secondary	The change of non-HDL-Cholesterol/HDL-Cholesterol ratio		baseline to 4 and 8 week
Secondary	The change of Apolipoprotein B/Apolipoprotein A1 ratio		baseline to 4 and 8 week
Secondary	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