OPEN STUDY ON THE SAFETY AND LONG-TERM TOLERABILITY OF SCH 58235 PLUS ATORVASTATIN IN SUBJECTS WITH CORONARY CARDIOPATHY OR MULTIPLE RISK FACTORS WITH PRIMARY HYPERCHOLESTEROLEMIA NOT CONTROLLED BY AN INITIAL DOSAGE OF ATORVASTATIN (10 MG)

SCHERING PLOUGH RESEARCH INSTITUTE,0 个研究点目标入组 0 人开始时间: 2000年1月1日最近更新: 2023年9月4日

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•Subjects who have successfully completed the 14-week double-blind study on the efficacy and safety of SCH 58235 with atorvastatin in subjects with coronary heart disease or multiple risk factors (Protocol P00693). The entry to this protocol must occur at the time of completing Protocol P00693.
•All women must have a negative pregnancy test before entering the study. Those who are of childbearing age must agree to use an effective barrier contraceptive method throughout the study, as well as 30 days after the last dose of atorvastatin.
•Postmenopausal women receiving postmenopausal hormone therapy or raloxifene should maintain a stable estrogen regimen (ERT), estrogen / progestin (HRT) or raloxifene during the study period.
•Subjects must be willing to comply with the NCEP Step I diet or a more strict diet during the study.
•Subjects must be willing to participate in the study and complete all evaluations.
•Subjects must agree to provide informed consent in writing.

•Patients who have been withdrawn from Protocol P00693 due to adverse effects or unsatisfactory compliance.
•People who are in a situation or have any condition that, at the discretion of the Investigator, could interfere with their optimal participation in the study.
•Women who are pregnant or breastfeeding.
•Subjects known to be HIV positive.

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