ASSESSMENT OF CLINICAL EFFECTS OF CHOLESTERYL ESTER TRANSFER PROTEIN INHIBITION WITH EVACETRAPIB IN PATIENTS AT A HIGH-RISK FOR VASCULAR OUTCOMES- THE ACCELERATE STUDY

ELI LILLY AND COMPANY,0 个研究点目标入组 0 人开始时间: 2013年3月21日最近更新: 2023年9月4日

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•[1] MALES OR FEMALES ≥ 18 YEARS OF AGE WITH A DIAGNOSIS OF HRVD (THAT IS, MEET AT LEAST ONE OF THE DISEASE DIAGNOSTIC CRITERIA DESCRIBED IN SECTION 8.1.1 BELOW), AND ARE CLINICALLY STABLE (AS JUDGED BY THE RESPONSIBLE PHYSICIAN)
•[2] MUST BE TREATED WITH A STATIN FOR AT LEAST 30 DAYS PRIOR TO SCREENING. IF NOT TREATED WITH A STATIN MUST HAVE DOCUMENTED STATIN INTOLERANCE, OR CONTRAINDICATION TO STATIN (SEE SECTION 7.1 FOR THE DEFINITIONS OF STATIN INTOLERANCE AND CONTRAINDICATION TO STATIN)
•[3] HAVE A SCREENING HDL-C ≤ 80 MG/DL (≤ 2.1 MMO1/L)
•[4] HAVE SCREENING TG ≤ 400 MG/DL (≤ 4.5 MMO1/L)
•[5] MEET 1 OF THE FOLLOWING CRITERIA:
•A) SCREENING LDL-C NO MORE THAN 10 MG/DL (0.3 MMO1/L) ABOVE THE TARGET CHOSEN BY THE INVESTIGATOR (EITHER LDL-C <100 MG/DL [<2.6 MMO1/L] OR LDL-C <70 MG/DL [<1.8 MMOL/L]),
•B) IF LDL-C IS GREATER THAN TARGET, THE PATIENT MUST BE ON MAXIMUM TOLERATED STATIN DOSE (FOR AT LEAST 30 DAYS) (SEE SECTION 7.1 FOR THE DEFINITION OF MAXIMUM TOLERATED STATIN DOSE), HAVE DOCUMENTED STATIN INTOLERANCE, OR CONTRAINDICATION TO STATIN

•GENERAL EXCLUSION CRITERIA
•[7] ARE INVESTIGATOR SITE PERSONNEL DIRECTLY AFFILIATED WITH THIS STUDY AND/OR THEIR IMMEDIATE FAMILIES. IMMEDIATE FAMILY IS DEFINED AS A SPOUSE, PARENT, CHILD, OR SIBLING, WHETHER BIOLOGICAL OR LEGALLY ADOPTED
•[8] ARE LILLY EMPLOYEES OR ARE EMPLOYEES OF THE ARO OR CRO (THAT IS, EMPLOYEES, TEMPORARY CONTRACT WORKERS, OR DESIGNEES RESPONSIBLE FOR THE CONDUCT OF THE STUDY). IMMEDIATE FAMILY OF LILLY EMPLOYEES MAY PARTICIPATE IN LILLY-SPONSORED CLINICAL STUDIES BUT ARE NOT PERMITTED TO PARTICIPATE AT A LILLY FACILITY. IMMEDIATE FAMILY IS DEFINED ABOVE
•[9] ARE CURRENTLY ENROLLED IN, OR DISCONTINUED WITHIN THE LAST 30 DAYS FROM, A CLINICAL TRIAL INVOLVING AN INVESTIGATIONAL PRODUCT OR NONAPPROVED USE OF A DRUG OR DEVICE (OTHER THAN THE INVESTIGATIONAL PRODUCT USED IN THIS STUDY), OR CONCURRENTLY ENROLLED IN ANY OTHER TYPE OF MEDICAL RESEARCH JUDGED NOT TO BE SCIENTIFICALLY OR MEDICALLY COMPATIBLE WITH THIS STUDY
•[10] HAVE PREVIOUSLY COMPLETED OR WITHDRAWN FROM THIS STUDY, OR WITHDRAWN FROM ANY OTHER STUDY INVESTIGATING EVACETRAPIB
•MEDICAL CONDITIONS EXCLUSION CRITERIA
•[11] FEMALE PATIENTS WHO ARE KNOWN TO BE PREGNANT
•[12] FEMALE PATIENTS WHO ARE BREASTFEEDING

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