Efficacy and Safety of Combination of Rosuvastatin and Ezetimibe in Patients With Primary Hypercholesterolemia
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| ClinicalTrials.gov Identifier: NCT03571087 |
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Recruitment Status :
Completed
First Posted : June 27, 2018
Last Update Posted : August 14, 2018
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| 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 |
| 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 |
|---|---|
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Experimental: HL140 5/10
Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg)
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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 |
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Experimental: HL140 10/10
Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg)
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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 |
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Experimental: HL140 20/10
Treatment(W0~W8), Extension(W9~W20): : 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg)
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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
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Drug: Rosuvastatin 5mg → HL140 5/10
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Experimental: Rosuvastatin 10mg → HL140 10/10
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Drug: Rosuvastatin 10mg → HL140 10/10
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Experimental: Rosuvastatin 20mg → HL140 20/10
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Drug: Rosuvastatin 20mg → HL140 20/10
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- Percentage change in LDL-Cholesterol from baseline [ Time Frame: Week 8 ]Percentage change(%) in LDL-Cholesterol from baseline at week 8
- Percentage change in LDL-Cholesterol from baseline [ Time Frame: Week 4 ]Percentage change(%) in LDL-Cholesterol from baseline at week 4
- Percentage change in TG from baseline [ Time Frame: Week 4, Week 8 ]Percentage change(%) in TG from baseline at week 4 and week 8
- Percentage change in TC from baseline [ Time Frame: Week 4, Week 8 ]Percentage change(%) in TC from baseline at week 4 and week 8
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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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
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
| Study Chair: | Kisik Kim | The Catholic University of Korea, Dagu St. Mary's Hospital |
| 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 |
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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 |