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

Primary Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03571087
• Other study ID #: HL_HL140_301
• Status: Completed
• Phase: Phase 3
• Start date: September 2014
• Est. completion date: September 2015

Study information

• Verified date: June 2018
• Source: Hanlim Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Primary Hypercholesterolemia

Intervention

Drug:
• HL140 5/10
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
• HL140 10/10
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
• HL140 20/10
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
• Rosuvastatin 5mg ? HL140 5/10
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
• Rosuvastatin 10mg ? HL140 10/10
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
• Rosuvastatin 20mg ? HL140 20/10
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanlim Pharm. Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change in LDL-Cholesterol from baseline	Percentage change(%) in LDL-Cholesterol from baseline at week 8	Week 8
Secondary	Percentage change in LDL-Cholesterol from baseline	Percentage change(%) in LDL-Cholesterol from baseline at week 4	Week 4
Secondary	Percentage change in TG from baseline	Percentage change(%) in TG from baseline at week 4 and week 8	Week 4, Week 8
Secondary	Percentage change in TC from baseline	Percentage change(%) in TC from baseline at week 4 and week 8	Week 4, Week 8
Secondary	Percentage of change in non-HDL-Cholesterol	Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8	Week 4, Week 8
Secondary	Percentage of change in HDL-Cholesterol	Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8	Week 4, Week 8
Secondary	Percentage of change weeks in Apo A-I	Percentage change(%) in Apo A-I from baseline at week 4 and week 8	Week 4, Week 8
Secondary	Percentage of change in Apo B	Percentage change(%) in Apo B from baseline at week 4 and week 8	Week 4, Week 8
Secondary	Percentage of change in Lipoprotein(a)	Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8	Week 4, Week 8
Secondary	The rate of change in hs-CRP	Percentage change(%) in hs-CRP from baseline at week 4 and week 8	Week 4, Week 8
Secondary	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	Week 4, Week 8