Carotid plaque in Human for ALL Evaluations with Aggressive Rosuvastatin Therapy: Evaluation by Magnetic Resonance Imaging - CHALLENGER trial

Juntendo University School of Medicine0 sites50 target enrollmentFebruary 15, 2008

Overview

Phase: 未知
Intervention: Not specified
Conditions: Not specified
Sponsor: Juntendo University School of Medicine
Enrollment: 50
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 15, 2008

End Date

June 1, 2010

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Juntendo University School of Medicine

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) Patients currently receiving other lipid\-lowering drugs apart from the test drug. 2\) Patients who have received any HMG\-CoA reductase inhibitor (statin) within 3 months before the observation period. 3\) Patients with severe carotid stenosis and marked calcification. 4\) Patients with the fasting TG level of more than 400 mg/dL. 5\) Patients with uncontrolled hypertension (DBP\&\#61619;100mmHg or SBP\&\#61619;200mmHg throughout the observation period). 6\) Patients with familial hypercholesterolemia that cannot be controlled by statin therapy. 7\) Patients with secondary hyperlipidemia due to thyroid dysfunction, Cushing's syndrome, nephrotic syndrome, systemic lupus erythematosus, etc. 8\) Patients receiving LDL apheresis. 9\) Patients on treatment with cyclosporine. 10\) Patients with renal dysfunction or on hemodialysis. 11\) Patients with a history of severe adverse effects or allergy to statins. 12\) Patients with confirmed malignancy, possible malignancy, or a history of malignancy. 13\) Patients with active liver disease or hepatic dysfunction (ALT, AST, ALP levels more than 2\.5 times the upper limit of normal, or a total bilirubin of more than 3\.0 mg/dL). 14\) Patients with the serum creatinine of more than 1\.5 mg/dL. 15\) Patients with the serum creatine kinase (CK) level at least 3 times the upper limit of normal. 16\) Patients with contraindications to MRI. 17\) Patients cannot be taken their MRI pictures. 18\) Patients who are ineligible for any other reason in the opinion of the investigator.