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

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: NCT03571087
Recruitment Status : Completed
First Posted : June 27, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Hanlim Pharm. Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Primary Hypercholesterolemia Drug: HL140 5/10 Drug: HL140 10/10 Drug: HL140 20/10 Drug: Rosuvastatin 5mg → HL140 5/10 Drug: Rosuvastatin 10mg → HL140 10/10 Drug: Rosuvastatin 20mg → HL140 20/10 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2015


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


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


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


Experimental: Rosuvastatin 5mg → HL140 5/10
  1. Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg
  2. Extension period(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)
Drug: Rosuvastatin 5mg → HL140 5/10
  1. 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

  2. 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

Experimental: Rosuvastatin 10mg → HL140 10/10
  1. Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg
  2. Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)
Drug: Rosuvastatin 10mg → HL140 10/10
  1. 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

  2. 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

Experimental: Rosuvastatin 20mg → HL140 20/10
  1. Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 20mg
  2. Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)
Drug: Rosuvastatin 20mg → HL140 20/10
  1. 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

  2. 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 Measures :
  1. Percentage change in LDL-Cholesterol from baseline [ Time Frame: Week 8 ]
    Percentage change(%) in LDL-Cholesterol from baseline at week 8


Secondary Outcome Measures :
  1. Percentage change in LDL-Cholesterol from baseline [ Time Frame: Week 4 ]
    Percentage change(%) in LDL-Cholesterol from baseline at week 4

  2. Percentage change in TG from baseline [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in TG from baseline at week 4 and week 8

  3. Percentage change in TC from baseline [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in TC from baseline at week 4 and week 8

  4. Percentage of change in non-HDL-Cholesterol [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in non-HDL-Cholesterol from baseline at week 4 and week 8

  5. Percentage of change in HDL-Cholesterol [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in HDL-Cholesterol from baseline at week 4 and week 8

  6. Percentage of change weeks in Apo A-I [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in Apo A-I from baseline at week 4 and week 8

  7. Percentage of change in Apo B [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in Apo B from baseline at week 4 and week 8

  8. Percentage of change in Lipoprotein(a) [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in Lipoprotein(a) from baseline at week 4 and week 8

  9. The rate of change in hs-CRP [ Time Frame: Week 4, Week 8 ]
    Percentage change(%) in hs-CRP from baseline at week 4 and week 8

  10. Percentage of patients reached treatment goals according to NCEP ATP III Guideline [ Time Frame: Week 4, Week 8 ]
    Percentage(%) of patients reached treatment goal, by NCEP ATP III guideline, at week 4 and week 8



Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT03571087


Sponsors and Collaborators
Hanlim Pharm. Co., Ltd.
Investigators
Layout table for investigator information
Study Chair: Kisik Kim The Catholic University of Korea, Dagu St. Mary's Hospital

Layout table for additonal information
Responsible Party: Hanlim Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03571087    
Other Study ID Numbers: HL_HL140_301
First Posted: June 27, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: June 2018
Additional relevant MeSH terms:
Layout table for MeSH terms
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