A 2-YEAR EXTENSION TO: A 76-WEEK, WORLDWIDE, MULTICENTER, DOUBLEBLIND,RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITYAND EFFICACY OF ANACETRAPIB WHEN ADDED TO ONGOING THERAPY WITH ASTATIN IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHDRISK-EQUIVALENT DISEASE: REVERSAL PERIOD EXTENDED FROM 12 WEEKS TO1-YEAR
- Registration Number
- PER-040-12
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 12
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method