None listed
Conditions
Interventions
FOLLOWING THE PRE-SCREENING/WASH-OUT PERIOD AND 2 WEEKS PLACEBO RUN-IN, ELIGIBLE PATIENTS WILL BE RANDOMIZED IN A 1:1 RATIO AT VISIT 3 TO ONE OF THE TWO TREATMENT GROUPS (SEE TABLE 2-1). AFTER 4 WEEKS
Sponsors
MERCK & CO.INC.,
Eligibility
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. PATIENT IS MALE OR FEMALE ≥ 18 AND ≤ 85 YEARS OF AGE ON DAY OF SIGNING INFORMED CONSENT. 2. PATIENT UNDERSTANDS THE STUDY´S PROCEDURES, ALTERNATIVE TREATMENTS AVAILABLE, RISKS INVOLVED WITH THE STUDY, AND VOLUNTARILY AGRESS TO PARTICIPATE BY GIVING WRITTEN INFORMED CONSENT. 3. A FEMALE PATIENT MUST MEET ONE OF THE FOLLOWING: a. OF REPRODUCTIVE POTENTIAL AND AGRESS TO REMAIN ABSTINENT OR USE (OR HAVE THEIR PARTNER USE) 2 ACCEPTABLE METHODS OF BIRTH CONTROL FOR THE STUDY DURATION. AN ACCEPTABLE METHOD OF BIRTH CONTROL IS DEFINED AS: . INTRAUTERINE DEVICE (IUD) . DIAPHRAGM WITH SPERMICIDE . CONDOM . VASECTOMY . CONTRACEPTIVE SPONGE (WITH SPERMICIDE) IS ACCEPTABLE AS A SINGLE METHOD OF BIRTH CONTROL BUT REQUIRES ONE OF THE FOLLOWING AS A SECOND METHOD: INTRAUTERINE DEVICE (IUD), DIAPHRAGM, CONDOM OR VASECTOMY. VASECTOMY: A SUCCESSFUL VASECTOMY IS DEFINED AS: (1) MICROSCOPIC DOCUMENTATION OF AZOOSPERMIA, OR (2) A VASECTOMY MORE THAN 2 YEARS AGO WITH NO RESULTANT PREGNANCY DESPITE SEXUAL ACTIVITY WITHOUT BIRTH CONTROL POSTVASECTOMY. b. NOT OF REPRODUCTIVE POTENTIAL IS ELIGIBLE WITHOUT REQUIRING THE USE OF CONTRACEPTION.
Exclusion criteria
Exclusion criteria: ALL VISITS GENERAL 1. PATIENT IS PREGNANT OR BREAST-FEEDING, OR EXPECTING TO CONCIEVE DURING THE STUDY THE 14-DAY POST STUDY FOLLOW-UP. 2. PATIENT HAS A HISTORY OF MALIGNANCY ≤ 5 YEARS PRIOR TO SIGNING THE INFORMED CONSENT, EXCEPT FOR ADEQUATELY TREATED BASAL CELL OR SQUAMOUS CEL SKIN CANCER OR IN SITU CERVICAL CANCER. 3. FEMALE PATIENT IS EXPECTING TO DONATE EGGS DURING THE STUDY, INCLUDING THE 14-DAY FOLLOW-UP OR A MALE PARIENT IS EXPECTING TO DONATE SPERM DURING THE STUDY, INCLUDING THE 14-DAY FOLLOW-UP. 4. PATIENT TO UNLIKELY TO ADTHERE TO THE STUDY PROCEDURES, KEEP APPOINTMENTS, OR IS PLANNING TO RELOCATE DURING THE STUDY, AN HAS A HISTORY OF CURRENT EVIDENCE OF ANY CONDITION THRAPY, OR LAB ABNORMALITY THAT MIGHT CONFOUND RESULTS OF THE STUDY, INTERFERE WITH THE PATIENT´S PARTICIPATION FOR THE FULL DURATION OF STUDY, OR IS NOT IN THE BEST INTEREST O THE PATIENT TO PARTICIPATE. 5. PATIENT CONSUMES MORE THAN 3 ALCOHOLIC DRINKS ON ANY GIVEN DAY OR MORE THAN 14 DRINK PER WEEK. PLEASE SEE SECTION 3.2.3 FOR DEFINITION OF ALCOHOLIC DRINKS. 6. PATIENT IS CURRENTLY PARTICIPATING IN OR HAS PARTICIPATED IN A STUDY WITH: • AN INVESTIGATIONAL COMPOUND (OTHER THAN LIPID-MODIFYING) WITHIN 30 DAYS AFTER THE POST-STUDY FOLLOW-UP PERIOD, PRIOR TO RANDOMIZATION.
Contacts
Public ContactAnibal Enrique Salas
COVANCE PERU SERVICES S.A.
Outcome results
None listed