Clinical trial NCT03571087: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Hypercholesterolemia
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-06-27
Enrollment: 374
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Percentage change in LDL-Cholesterol from baseline
timeFrame: Week 8
Secondary outcomes:
measure: Percentage change in LDL-Cholesterol from baseline
timeFrame: Week 4
measure: Percentage change in TG from baseline
timeFrame: Week 4, Week 8
measure: Percentage change in TC from baseline
timeFrame: Week 4, Week 8
measure: Percentage of change in non-HDL-Cholesterol
timeFrame: Week 4, Week 8
measure: Percentage of change in HDL-Cholesterol
timeFrame: Week 4, Week 8
measure: Percentage of change weeks in Apo A-I
timeFrame: Week 4, Week 8
measure: Percentage of change in Apo B
timeFrame: Week 4, Week 8
measure: Percentage of change in Lipoprotein(a)
timeFrame: Week 4, Week 8
measure: The rate of change in hs-CRP
timeFrame: Week 4, Week 8
measure: Percentage of patients reached treatment goals according to NCEP ATP III Guideline
timeFrame: Week 4, Week 8
Other outcomes:
Locations:
Study officials:
affiliation: The Catholic University of Korea, Dagu St. Mary's Hospital
name: Kisik Kim
role: STUDY_CHAIR
References: