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)

NCT02749994 | Completed Phase 3

• 1 other identifier: ID-ROEZ-302
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline to 8 week in LDL-Cholesterol

  baseline and 8 week

Secondary Outcomes (13)

• Percent change from baseline to 4 and 8 week in Total Cholesterol

  baseline to 4 and 8 week

• Percent change from baseline to 4 and 8 week in Triglyceride

  baseline to 4 and 8 week

• Percent change from baseline to 4 and 8 week in HDL-Cholesterol

  baseline to 4 and 8 week

• Percent change from baseline to 4 and 8 week in non-HDL-Cholesterol

  baseline to 4 and 8 week

• Percent change from baseline to 4 and 8 week in Apolipoprotein B

  baseline to 4 and 8 week

Study Arms (6)

R5

ACTIVE COMPARATOR

Rosuvastatin 5mg

Drug: Rosuvastatin

R10

ACTIVE COMPARATOR

Rosuvastatin 10mg

Drug: Rosuvastatin

R20

ACTIVE COMPARATOR

Rosuvastatin 20mg

Drug: Rosuvastatin

R5/E10

EXPERIMENTAL

Rosuvastatin 5mg/Ezetimibe 10mg

Drug: Rosuvastatin; Drug: Ezetimibe

R10/E10

EXPERIMENTAL

Rosuvastatin 10mg/Ezetimibe 10mg

Drug: Rosuvastatin; Drug: Ezetimibe

R20/E10

EXPERIMENTAL

Rosuvastatin 20mg/Ezetimibe 10mg

Drug: Rosuvastatin; Drug: Ezetimibe

Interventions

Rosuvastatin DRUG

R10; R10/E10; R20; R20/E10; R5; R5/E10

Ezetimibe DRUG

R10/E10; R20/E10; R5/E10

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IlDong Pharmaceutical Co Ltd: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 29402522 DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Rosuvastatin Calcium; Ezetimibe

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines

Study Officials

• Hyo-soo Kim, MD/PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2016
• First Posted: April 25, 2016
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: June 13, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)