Hypercholesterolemia Familial Hypercholesterolemia
Conditions
Interventions
A Livalo 2 mg tablet is orally administered once daily (after dinner).
Sponsors
KOWA company, ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study enrolls patients with hypercholesterolemia or familial hypercholesterolemia who satisfy all of the following requirements, are rated as indicated for Livalo Tablets and give their own consent to the study: 1) Age over 20 and less than 80 at the time of consent; 2) LDL-cholesterol level over 120 mg/dL within 4 weeks before the start of treatment with the test drug; 3) Individuals suspected of having coronary artery disease based on subjective symptoms (chest pain, etc.) and findings from various tests of the cardiovascular system or individuals rated as requiring coronary arteriography, angioscopy and intravascular ultrasonography for the purpose of follow-up of the previous interventions, etc.; 4) Individuals possessing at least one plaque in the coronary artery branches detectable by coronary arteriography* after acquisition of consent and rated at Grade 2-4 (excluding Grade 5) by angioscopy**; *: Lesions having undergone or planned to undergo intervention are excluded from angioscopy. **:Grade 0;not yellow, Grade 1; yellowish, Grade 2;yellow, Grade 3;deep yellow, Grade 4;brilliant yellow, Grade 5;thrombus
Exclusion criteria
Exclusion criteria: 1) Patients currently receiving Livalo Tablets or having discontinued Livalo therapy before; 2) Patients absolutely or relatively contraindicated against Livalo Tablets; 3) Patients with hepatopathy or having ALT (GPT) or AST (GOT) level exceeding 2.5 times the upper limit of the criterion range; 4) Patients with compromised renal function (serum creatinine over 2.0 mg/dL); 5) Patients with a history of severe myopathy or CK (CPK) exceeding 2.5 times the upper limit of the criterion range; 6) Patients within 24 hours after onset of acute myocardial infarction; 7) Patients within 1 month after onset of cerebrovascular disease; 8) Patients with a history of malignant tumor or complicated by malignant tumors within 5 years before the start of treatment with the test drug; 9) Poorly controlled diabetic patients (HbA1C over 8.0%); 10) Patients receiving LDL apheresis; 11) Patients with the homozygote type of familial hypercholesterolemia; 12) Patients requiring treatment with the drugs whose concomitant use during this study is prohibited; - Cyclosporine preparations - Fibrates - Nicotinic acid preparations - HMG-CoA reductase inhibitors other than the test drug - Cholestyramine 13)Drug addicts 14) Patients participating in some other clinical trials at present or having participated in other clinical trials completed within 4 months before; 15) Individuals judged as inappropriate for this post-marketing clinical study by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography) | — |
Secondary
| Measure | Time frame |
|---|---|
| Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography) | — |
Countries
Japan
Contacts
Public ContactYasunori Ueda
Osaka Police Hospital Cardiovascular Division
Outcome results
None listed