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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02749994
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Hypercholesterolemia Drug: Rosuvastatin Drug: Ezetimibe Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017


Arm Intervention/treatment
Active Comparator: R5
Rosuvastatin 5mg
Drug: Rosuvastatin
Active Comparator: R10
Rosuvastatin 10mg
Drug: Rosuvastatin
Active Comparator: R20
Rosuvastatin 20mg
Drug: Rosuvastatin
Experimental: R5/E10
Rosuvastatin 5mg/Ezetimibe 10mg
Drug: Rosuvastatin
Drug: Ezetimibe
Experimental: R10/E10
Rosuvastatin 10mg/Ezetimibe 10mg
Drug: Rosuvastatin
Drug: Ezetimibe
Experimental: R20/E10
Rosuvastatin 20mg/Ezetimibe 10mg
Drug: Rosuvastatin
Drug: Ezetimibe



Primary Outcome Measures :
  1. Percent change from baseline to 8 week in LDL-Cholesterol [ Time Frame: baseline and 8 week ]

Secondary Outcome Measures :
  1. Percent change from baseline to 4 and 8 week in Total Cholesterol [ Time Frame: baseline to 4 and 8 week ]
  2. Percent change from baseline to 4 and 8 week in Triglyceride [ Time Frame: baseline to 4 and 8 week ]
  3. Percent change from baseline to 4 and 8 week in HDL-Cholesterol [ Time Frame: baseline to 4 and 8 week ]
  4. Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol [ Time Frame: baseline to 4 and 8 week ]
  5. Percent change from baseline to 4 and 8 week in Apolipoprotein B [ Time Frame: baseline to 4 and 8 week ]
  6. Percent change from baseline to 4 and 8 week in Apolipoprotein A1 [ Time Frame: baseline to 4 and 8 week ]
  7. Percent change from baseline to 4 week in LDL-Cholesterol [ Time Frame: baseline to 4 week ]
  8. Percent change from baseline to 4 and 8 week in hs-CRP(high-sensitivity C-reactive protein) [ Time Frame: baseline to 4 and 8 ]
  9. The change of LDL-Cholesterol/HDL-Cholesterol ratio [ Time Frame: baseline to 4 and 8 week ]
  10. The change of Total Cholesterol/HDL-Cholesterol ratio [ Time Frame: baseline to 4 and 8 week ]
  11. The change of non-HDL-Cholesterol/HDL-Cholesterol ratio [ Time Frame: baseline to 4 and 8 week ]
  12. The change of Apolipoprotein B/Apolipoprotein A1 ratio [ Time Frame: baseline to 4 and 8 week ]
  13. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02749994


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
IlDong Pharmaceutical Co Ltd
Investigators
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Principal Investigator: Hyo-soo Kim, MD/PhD Seoul National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: IlDong Pharmaceutical Co Ltd
ClinicalTrials.gov Identifier: NCT02749994    
Other Study ID Numbers: ID-ROEZ-302
First Posted: April 25, 2016    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors