Justification for Atherosclerosis Regression Treatment [JART Extension Study]

Not Applicable

• Conditions: Hypercholesterolemia

• Registration Number: JPRN-UMIN000005774
• Lead Sponsor: Japan Atherosclerosis Regressive Treatment Study Group

Brief Summary

ohara R et al. : Circ J. 2012;76(1): 221-229 Nohara R et al. : Circ J 2013; 77(6): 1526 -1533

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-14
• Study Completion: 2011-12-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

(1) Patients that require lipid-lowering therapy other than the study drug or specified lipid-lowering drugs (anion-exchange resin, inhibitor of probucol, and ethyl icosapentate (EPA)) (2) Patients who have taken statins within one month before the start of the clinical trial. (3) Patients suspected of having serious carotid artery stenosis (greater than 80%) or having serious calcification. (4) Patients with familial hypercholesterolemia or secondary hypercholesterolemia. (5) Patients with fasting serum TG >= 400 mg/dL. (6) Patients with a history of sensitivity to statins. (7) Patients with uncontrolled hypertension. (8) Patients with Type I diabetes or uncontrolled Type II diabetes. (9) Patients who have experienced myocardial infarction or a cerebral stroke within 3 months or Patients with serious heart failure (NYHA class III to IV). (10) Patients with active hepatic disease. (11) Patients with renal disorder (Cr >= 2.0 mg/dL or Ccr < 30 mL/min/1.73m2). (12) Patients with CK > 500 IU/L. (13) Patients currently being treated with cyclosporine. (14) Patients that are pregnant or potentially pregnant, patients breast-feeding, or patients aiming to become pregnant during the clinical trial. (15) Patients with or suspected of having a malignant tumor, or patients with a history of malignant tumor except for the patients in whom recurrences have not been confirmed by routine observation after treatment. (16) Patients with hypothyroidism, hereditary muscular diseases (muscular dystrophy, etc.) or familial history of these diseases. Patients with history of drug-related muscular disorder. (17) Patients with drug abuse or alcoholic. (18) Patients who are ineligible in the opinion of the investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified