None listed
Conditions
Interventions
WEEK 52 OF STUDY BCDS AND STUDY BCDT CORRESPOND TO WEEK 0 IN STUDY BCDX. THE WEEK 52 VISIT IN STUDY BCDS OR STUDY BCDT SHOULD OCCUR ON THE SAME CALENDAR DAY (OR WITHIN 3 DAYS AFTER) AS THE FIRST VISIT
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: [1] HAVE COMPLETED 52 WEEKS OF TREATMENT IN STUDY BCDS OR STUDY BCDT. [2A] FOR FEMALE PATIENTS OF CHILDBEARING POTENTIAL, MUST TEST NEGATIVE FOR PREGNANCY AT THE TIME OF ENROLLMENT AND AGREE TO USE A RELIABLE METHOD OF BIRTH CONTROL OR REMAIN ABSTINENT DURING THE STUDY OR FOR AT LEAST 8 WEEKS FOLLOWING THE LAST DOSE OF STUDY DRUG, WHICHEVER IS LONGER, OR [2B] FOR FEMALE PATIENTS OF NON-CHILDBEARING POTENTIAL, DEFINED AS: . WOMEN WHO HAVE HAD SURGICAL STERILIZATION (HYSTERECTOMY OR BILATERAL OOPHORECTOMY OR TUBAL LIGATION) . WOMEN ≥ 60 YEARS OF AGE . WOMEN ≥ 40 AND < 60 YEARS OF AGE WHO HAVE HAD A CESSATION OF MENSES FOR AT LEAST 12 MONTHS AND A FOLLICLE-STIMULATING HORMONE (FSH) TEST CONFIRMING NON-CHILDBEARING POTENTIAL (FSH ≥ 40 MIU/ML). [3] HAVE GIVEN WRITTEN INFORMED CONSENT APPROVED BY LILLY OR ITS DESIGNEE AND THE INVESTIGATIONAL REVIEW BOARD/ETHICAL REVIEW BOARD (IRB/ERB) GOVERNING THE SITE.
Exclusion criteria
Exclusion criteria: [4] PRESENCE OF SIGNIFICANT UNCONTROLLED CEREBROCARDIOVASCULAR (FOR EXAMPLE: MYOCARDIAL INFARCTION [MI], UNSTABLE ANGINA, UNSTABLE ARTERIAL HYPERTENSION, SEVERE HEART FAILURE, OR CEREBROVASCULAR ACCIDENT), RESPIRATORY, HEPATIC, RENAL, GASTROINTESTINAL, ENDOCRINE, HEMATOLOGIC OR NEUROPSYCHIATRIC DISORDERS, OR ABNORMAL LABORATORY VALUES AT BASELINE THAT IN THE OPINION OF THE INVESTIGATOR POSE AN UNACCEPTABLE RISK TO THE PATIENT IF STUDY DRUG WOULD BE ADMINISTERED. [5] HAVE ANY OTHER CONDITION THAT RENDERS THE PATIENT UNABLE TO UNDERSTAND THE NATURE, SCOPE, AND POSSIBLE CONSEQUENCES OF THE STUDY OR PRECLUDES THE PATIENT FROM FOLLOWING AND COMPLETING THE PROTOCOL, IN THE OPINION OF THE INVESTIGATOR. [6] ARE UNWILLING OR UNABLE TO COMPLY WITH STUDY PROCEDURES. [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 REPRESENTATIVES OF A THIRD PARTY ORGANIZATION (TPO) INVOLVED IN THE STUDY WHO REQUIRE EXCLUSION OF THEIR EMPLOYEES.
Countries
United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed