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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) (I-ROSETTE)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Rosuvastatin
Ezetimibe
Sponsored by
IlDong Pharmaceutical Co Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Experimental

Experimental

Experimental

Arm Label

R5

R10

R20

R5/E10

R10/E10

R20/E10

Arm Description

Rosuvastatin 5mg

Rosuvastatin 10mg

Rosuvastatin 20mg

Rosuvastatin 5mg/Ezetimibe 10mg

Rosuvastatin 10mg/Ezetimibe 10mg

Rosuvastatin 20mg/Ezetimibe 10mg

Outcomes

Primary Outcome Measures

Percent change from baseline to 8 week in LDL-Cholesterol

Secondary Outcome Measures

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

Full Information

First Posted
April 19, 2016
Last Updated
June 11, 2018
Sponsor
IlDong Pharmaceutical Co Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT02749994
Brief Title
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)
Acronym
I-ROSETTE
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 2017 (Actual)
Study Completion Date
February 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IlDong Pharmaceutical Co Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R5
Arm Type
Active Comparator
Arm Description
Rosuvastatin 5mg
Arm Title
R10
Arm Type
Active Comparator
Arm Description
Rosuvastatin 10mg
Arm Title
R20
Arm Type
Active Comparator
Arm Description
Rosuvastatin 20mg
Arm Title
R5/E10
Arm Type
Experimental
Arm Description
Rosuvastatin 5mg/Ezetimibe 10mg
Arm Title
R10/E10
Arm Type
Experimental
Arm Description
Rosuvastatin 10mg/Ezetimibe 10mg
Arm Title
R20/E10
Arm Type
Experimental
Arm Description
Rosuvastatin 20mg/Ezetimibe 10mg
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Primary Outcome Measure Information:
Title
Percent change from baseline to 8 week in LDL-Cholesterol
Time Frame
baseline and 8 week
Secondary Outcome Measure Information:
Title
Percent change from baseline to 4 and 8 week in Total Cholesterol
Time Frame
baseline to 4 and 8 week
Title
Percent change from baseline to 4 and 8 week in Triglyceride
Time Frame
baseline to 4 and 8 week
Title
Percent change from baseline to 4 and 8 week in HDL-Cholesterol
Time Frame
baseline to 4 and 8 week
Title
Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol
Time Frame
baseline to 4 and 8 week
Title
Percent change from baseline to 4 and 8 week in Apolipoprotein B
Time Frame
baseline to 4 and 8 week
Title
Percent change from baseline to 4 and 8 week in Apolipoprotein A1
Time Frame
baseline to 4 and 8 week
Title
Percent change from baseline to 4 week in LDL-Cholesterol
Time Frame
baseline to 4 week
Title
Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein)
Time Frame
baseline to 4 and 8
Title
The change of LDL-Cholesterol/HDL-Cholesterol ratio
Time Frame
baseline to 4 and 8 week
Title
The change of Total Cholesterol/HDL-Cholesterol ratio
Time Frame
baseline to 4 and 8 week
Title
The change of non-HDL-Cholesterol/HDL-Cholesterol ratio
Time Frame
baseline to 4 and 8 week
Title
The change of Apolipoprotein B/Apolipoprotein A1 ratio
Time Frame
baseline to 4 and 8 week
Title
The ratio of subjects who reach the goal of LDL-Cholesterol according to NCEP(National Cholesterol Education Program Adult Treatment Panel) III Guideline
Time Frame
baseline to 4 and 8 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 ~ 79 years old Patients who confirmed hypercholesterolemia. Patients who requiring drug therapy according to NCEP ATP(National Cholesterol Education Program Adult Treatment Panel) III Guideline at Visit2. Patients with Triglyceride< 400 at Visit 2. 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) Patients who agreed to participate in the trial Exclusion Criteria: 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. A heavy alcohol consumer. (alcohol > 25 units/week) Patients with severe renal disease. (creatinine ≥ 2.0 mg/dL) Patients with active liver disease and AST(aspartate transaminase) or ALT(alanine transaminase) > 2 times of upper limit of normal range. Patients with CPK(creatine phosphokinase) > 2 x upper limit of normal range. Patients who have a endocrine or metabolic diseases known to affect the serum phospholipid or lipoprotein. Patients with HIV(human immunodeficiency virus positive. Patients who have a acute arteriopathy. Patients with uncontrolled hypertension. Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Patients who have a drugs absorption disorder by gastrointestinal surgery or gastrointestinal disorder. Patients with tumor. Patients who have hormonal therapy. Pregnancy or breastfeeding patients who don't agree to use adequate contraception. Patients who are judged unsuitable to participate in this study by investigator. Patients taking other clinical trial drugs within 30 days from the time of visit for screening.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-soo Kim, MD/PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29402522
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.
Results Reference
derived

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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)

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