None listed
Conditions
Interventions
ON COMPLETION OF VISIT 26 PROCEDURES, IVRS WILL SELECT PATIENTS PREVIOUSLY TREATED WITH ANACETRAPIB OR PLACEBO IN A 4: 1 RATIO FOR PARTICIPATION IN THE EXTENDED REVERSAL PHASE WHICH IS PN 019-12 (REFE
IF PATIENT´S LDL-C IS ≥
70 MG/DL (1.8 MMOL/L) AND/OR ≥
100 MG/DL (2.59 MMOL/L) TO ALLOW THE TREATING PHYSICIAN TO MODIFY LIPID-MEDICATIONS AS NEEDED. PATIENTS WILL HAVE TOTAL OF 5 CLINIC VISITS DURING THE REVERSAL PHASE. PLASMA CONCENTRATION OF ANACETRAPI
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
80 Years to 18 Years
Inclusion criteria
Inclusion criteria: APPLIES TO PATIENTS WHO ARE SELECTED TO PARTICIPATE IN EXTENDED REVERSAL PHASE (PN 019-12) 1. PATIENT HAS COMPLETED VISIT 26 PROCEDURES OF THE 2-YR EXTENSION STUDY. NOTE: THIS INCLUDES PATIENTS WHO COMPLETE THE 2-YR EXTENSION STUDY AND PATIENTS WHO DISCONTINUE FROM THE 2-YEAR EXTENSION STUDY, AFTER IMPLEMENTATION 0F PN 019-12. 2. PATIENT IS SELECTED BY IVRS TO PARTICIPATE IN THE EXTENDED REVERSAL PHASE. 3. PATIENT HAS AN UNDERSTANDING OF THE STUDY PROCEDURES AND AGREES TO PARTICIPATE IN THE STUDY BY GIVING WRITTEN INFORMED CONSENT. 4. A PATIENT WHO IS OFREPRODUCTIVE POTENTIAL AGREES TO REMAIN ABSTINENTE OR USE (OR HAVE THEIR PARTNER USE) 2 ACCEPTABLE METHODS OF BIRTH CONTROL FOR THE DURATION OF THE STUDY. ACCEPTABLE METHODS OF BIRTH CONTROL ARE: INTRAUTERINE DEVICE (IUD), DIAPHRAGM WITH SPERMICIDE, CONDOM, VASECTOMY, AND HORMONAL CONTRACEPTION.
Exclusion criteria
Exclusion criteria: APPLIES TO PATIENTS WHO ARE SELECTED TO PARTICIPATE IN EXTENDED REVERSAL PHASE (PN 019-12) 1. PATIENT HAS DEVELOPED ANY MEDICAL CONDITION OR DISORDER THAT, IN THE OPINION OF THE INVESTIGATOR OR MERCK CLINICAL MONITOR, MIGHT POSE A RISK TO THE PATIENT. 2. PATIENT PLANS TO ENTER ANOTHER INVESTIGATIONAL DRUG STUDY INVOLVING LIPID-MODIFYING DRUG INCLUDING ANACETRAPIB DURING THE STUDY.
Countries
Peru
Contacts
Public ContactRodolfo Lozano
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed