A Post-Marketing Clinical Study of Livalo Tablets: Evaluation of Effects on Yellow Plaques in the Coronary Arteries of Patients with Hypercholesterolemia

UMIN ID: UMIN000001107

Registered date:03/04/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Hypercholesterolemia Familial Hypercholesterolemia
• Date of first enrollment: 2004/11/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): A Livalo 2 mg tablet is orally administered once daily (after dinner).

Outcome(s)

• Primary Outcome: Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography)
• Secondary Outcome: Effects of the drug on changes in plaque color (assessed by angioscopy) and plaque volume and echo density (evaluated by intravascular ultrasonography)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 80years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: KOWA company, ltd.
• Source(s) of Monetary Support: KOWA company, ltd.