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Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

Primary Purpose

Primary Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

HL140 5/10

HL140 10/10

HL140 20/10

Rosuvastatin 5mg → HL140 5/10

Rosuvastatin 10mg → HL140 10/10

Rosuvastatin 20mg → HL140 20/10

About this trial

This is an interventional treatment trial for Primary Hypercholesterolemia

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Aged over 19 years
Signed informed consent form
At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL

Exclusion Criteria:

At visit 1, BMI ≥ 30kg/㎡
Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe
Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome
Creatine Kinase > 5 x upper limit of normal
ALT or AST > 3 x upper limit of normal
Has a activity/chronic hepatic disease or HIV-positive
Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein
- Uncontrolled diabetes mellitus(HbA1c ≥9%)
- Hypothyroidism (TSH > 1.5 x upper limit of normal rate at the screening )
Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg)
Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening)
Severe heart failure (NYHA Class III or IV)
Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder
History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years)
Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms)
Pregnant or breast-feeding
Patients who have a drug or alcohol abuse or are being treated for psychological disorder
Patients who were treated with other investigational drug within 12 weeks prior to screening
Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

HL140 5/10

HL140 10/10

HL140 20/10

Rosuvastatin 5mg → HL140 5/10

Rosuvastatin 10mg → HL140 10/10

Rosuvastatin 20mg → HL140 20/10

Arm Description

Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)

Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)

Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg Extension period(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 20mg Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)

Outcomes

Primary Outcome Measures

Percentage change in LDL-Cholesterol from baseline

Percentage change(%) in LDL-Cholesterol from baseline at week 8

Secondary Outcome Measures

Percentage change in LDL-Cholesterol from baseline

Percentage change(%) in LDL-Cholesterol from baseline at week 4

Percentage change in TG from baseline

Percentage change(%) in TG from baseline at week 4 and week 8

Percentage change in TC from baseline

Percentage change(%) in TC from baseline at week 4 and week 8

Percentage of change in non-HDL-Cholesterol

Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8

Percentage of change in HDL-Cholesterol

Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8

Percentage of change weeks in Apo A-I

Percentage change(%) in Apo A-I from baseline at week 4 and week 8

Percentage of change in Apo B

Percentage change(%) in Apo B from baseline at week 4 and week 8

Percentage of change in Lipoprotein(a)

Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8

The rate of change in hs-CRP

Percentage change(%) in hs-CRP from baseline at week 4 and week 8

Percentage of patients reached treatment goals according to NCEP ATP III Guideline

Percentage(%) of patients reached treatment goal, by NCEP ATP III guideline, at week 4 and week 8

Full Information

NCT ID

NCT03571087

First Posted

June 17, 2018

Last Updated

August 12, 2018

Sponsor

Hanlim Pharm. Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03571087

Brief Title

Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

Official Title

A Multi Center, Randomized, Double-blind, Parallel, Factorial Design, Therapeutic Phase III Study to Evaluate the Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hanlim Pharm. Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate efficacy and safety of HL140 in patients with primary hypercholesterolemia.

Detailed Description

The purpose of this study is to demonstrate that the efficacy of combination drug of rosuvastatin/ezetimibe is superior to single rosuvastatin drug and to confirm the safety of combination drug of rosuvastatin/ezetimibe

6. Conditions and Keywords

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

Primary Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

374 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HL140 5/10

Arm Type

Experimental

Arm Description

Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)

Arm Title

HL140 10/10

Arm Type

Experimental

Arm Description

Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)

Arm Title

HL140 20/10

Arm Type

Experimental

Arm Description

Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)

Arm Title

Rosuvastatin 5mg → HL140 5/10

Arm Type

Experimental

Arm Description

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg Extension period(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)

Arm Title

Rosuvastatin 10mg → HL140 10/10

Arm Type

Experimental

Arm Description

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)

Arm Title

Rosuvastatin 20mg → HL140 20/10

Arm Type

Experimental

Arm Description

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 20mg Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)

Intervention Type

Drug

Intervention Name(s)

HL140 5/10

Intervention Description

1) Treatment(W0~W8), Extension(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ ●: HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab.5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Intervention Type

Drug

Intervention Name(s)

HL140 10/10

Intervention Description

1) Treatment(W0~W8), Extension(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ ○: HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Intervention Type

Drug

Intervention Name(s)

HL140 20/10

Intervention Description

1) Treatment(W0~W8), Extension(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 5mg → HL140 5/10

Intervention Description

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg : ○♤♡■△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo,♡: HL140 20/10mg placebo, ■: Crestor Tab. 5mg, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo Extension period(W9~W20): 6Tab./q.d. HL1405/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇ HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 10mg → HL140 10/10

Intervention Description

Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg : ○♤♡□▲◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, ▲: Crestor Tab. 10mg, ◇: Crestor Tab. 20mg placebo Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇ HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Intervention Type

Drug

Intervention Name(s)

Rosuvastatin 20mg → HL140 20/10

Intervention Description

Treatment(W0~W8): 6Tab./q.d.Rosuvastatin 20mg : ○♤♡□△◆ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◆: Crestor Tab. 20mg Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo

Primary Outcome Measure Information:

Title

Percentage change in LDL-Cholesterol from baseline

Description

Percentage change(%) in LDL-Cholesterol from baseline at week 8

Time Frame

Week 8

Secondary Outcome Measure Information:

Title

Percentage change in LDL-Cholesterol from baseline

Description

Percentage change(%) in LDL-Cholesterol from baseline at week 4

Time Frame

Week 4

Title

Percentage change in TG from baseline

Description

Percentage change(%) in TG from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage change in TC from baseline

Description

Percentage change(%) in TC from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage of change in non-HDL-Cholesterol

Description

Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage of change in HDL-Cholesterol

Description

Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage of change weeks in Apo A-I

Description

Percentage change(%) in Apo A-I from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage of change in Apo B

Description

Percentage change(%) in Apo B from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage of change in Lipoprotein(a)

Description

Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

The rate of change in hs-CRP

Description

Percentage change(%) in hs-CRP from baseline at week 4 and week 8

Time Frame

Week 4, Week 8

Title

Percentage of patients reached treatment goals according to NCEP ATP III Guideline

Description

Percentage(%) of patients reached treatment goal, by NCEP ATP III guideline, at week 4 and week 8

Time Frame

Week 4, Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged over 19 years Signed informed consent form At visit 1 and visit 2, LDL-Cholesterol ≤ 250mg/dL and Triglyceride ≤ 400mg/dL Exclusion Criteria: At visit 1, BMI ≥ 30kg/㎡ Has a history of myopathy or rhabdomyolysis cased by statin treatment, hereditary myopathy or family history and hypersensitivity to statin(HMG-CoA reductase inhibitor) and component of ezetimibe Has a Severe renal disorder(Ccr <30mL/min) or nephrotic syndrome Creatine Kinase > 5 x upper limit of normal ALT or AST > 3 x upper limit of normal Has a activity/chronic hepatic disease or HIV-positive Has a endocrine or metabolic diseases known to affect the serum phospholipid or protein Uncontrolled diabetes mellitus(HbA1c ≥9%) Hypothyroidism (TSH > 1.5 x upper limit of normal rate at the screening ) Uncontrolled hypertension (SBP ≥180mmHg or DBP ≥110mmHg) Has a acute arteriopathy(history of unstable angina, cardiac infarction, transient ischemic stroke, cerebrovascular disease, coronary artery bypass, coronary intervention within 12 weeks prior to screening) Severe heart failure (NYHA Class III or IV) Has a drug absorption disorder by gastrointestinal surgery or gastrointestinal disorder History of malignant tumor including myelogenous and lymphoma within 5 years (Participation is possible, if the tumor has not recurred for more than 5 years) Subject with genetic deficiency such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption Female subjects of childbearing potential who disagree with the contraceptive methods(surgical sterilization, intrauterine device or condoms) Pregnant or breast-feeding Patients who have a drug or alcohol abuse or are being treated for psychological disorder Patients who were treated with other investigational drug within 12 weeks prior to screening Other patients who are inappropriate to participate in the study considered by the investigator or other study staffs

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kisik Kim

Organizational Affiliation

The Catholic University of Korea, Dagu St. Mary's Hospital

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia

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