None listed
Conditions
Interventions
PATIENTS WILL ENTER THE EXTENSION FROM EITHER PART 1 OR PART 2 OF THE BASE STUDY.
A 14-DAY POST-TREATMENT FOLLOW-UP PHONE CALL WILL BE MADE TO ALL PATIENTS AFTER THE LAST DOSE IS TAKEN TO ASSESS FO
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: VISIT 1 INCLUSION CRITERIA 1. PATIENT COMPLETED EITHER PART 1 OR PART 2 OF THE BASE STUDY. 2. PATIENT IS ABLE TO UNDERSTAND STUDY PROCEDURES AND AGREES TO PARTICIPATE IN THE EXTENSION STUDY BY GIVING WRITTEN INFORMED CONSENT. 3. A FEMALE PATIENT WHO IS OF REPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENT OR USE (OR HAVE THEIR PARTNER USE) 2 ACCEPTABLE METHODS OB BIRTH CONTROL WITHIN THE PROJECTED DURATION OF THE STUDY. ACCEPTABLE METHODS OF BIRTH CONTROL ARE: INTRAUTERINE DEVICE (IUD), DIAPHRAGM WITH SPERMICIDE, CONTRACEPTIVE SPONGE, CONDOM, VASECTOMY. A FEMALE PATIENT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS ELIGIBLE WITHOUT REQUIRING THE USE OF CONTRACEPTION. A FEMALE PATIENT WHO IS NOT OF REPRODUCTIVE POTENTIAL IS DEFINED AS: ONE WHO HAS EITHER 1) REACHED NATURAL MENOPAUSE (DEFINED AS 6 MONTHS OF SPONTANEOUS AMENORRHEA WITH SERUM FSH LEVELS IN THE POSTMENOPAUSAL RANGE AS DETERMINED BY THE LABORATORY, OR 12 MONTHS OF SPONTANEOUS AMENORRHEA, 2) 6 WEEKS POST SURGICAL BILATERAL OOPHORECTOMY WITH OR WITHOUT HYSTERECTOMY, 3) BILATERAL TUBAL LIGATION OR 4) HYSTERECTOMY. NOTE: HORMONAL CONTRACEPTIVES MAY NOT BE CONSIDERED AS ONE OF THE 2 ACCEPTABLE METHODS OF BIRTH CONTROL REQUIRED FOR INCLUSION IN THIS STUDY, HOWEVER, CONCOMITANT USE OF THEM IS PERMITTED.
Exclusion criteria
Exclusion criteria: VISIT 1 EXCLUSION CRITERIA 1. PATIENT HAD ANY SEROUS, DRUG-RELATED, OR UNRESOLVED CLINICAL OR LABORATORY ADVERSE EXPERIENCES DURING PARTICIPATION IN THE BASE STUDY THAT IN THE INVESTIGATOR´S MEDICAL JUDGMENT WOULD PRECLUDE THE PATIENT FROM PARTICIPATION IN OR COMPLETION OF, THE EXTENSION STUDY. 2. PATIENT MEETS ANY OF THE CRITERIA FOR DISCONTINUATION IN THE ASE STUDY, INCLUDING REQUIREMENT OF THERAPY WITH MEDICATION LISTED IN APPENDIX 6.3 (CYP3A4 INDUCERS/INHIBITORS AND PGP INHIBITORS). 3. PATIENT HAS CLINICALLY SIGNIFICANT CHANGES IN HIS/HER GENERAL MEDICAL CONDITION SINCE ENROLLING IN HE BSE STUDY THAT IN THE INVESTIGATOR´S MEDICAL JUDGMENT WOULD PRECLUDE THE PATIENT FROM PARTICIPATING IN, OR COMPLETING, THE STUDY. 4. PATIENT HAS BEEN OFF BASE STUDY DRUG FOR ˃ 14 DAYS AT VISIT 1. 5. PATIENT IS PREGNANT OR BREAST-FEEDING, OR EXPECTING TO CONCEIVE WITHIN THE PROJECTED DURATION OF THE STUDY.
Contacts
Public ContactRodolfo Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed