A WORLDWIDE, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO ASSESS THE TOLERABILITY AND EFFICACY OF ANACETRAPIB WHEN ADDED TO ONGOING THERAPY WITH A STATIN IN PATIENTS WITH CORONARY HEART DISEASE (CHD) OR CHD RISK-EQUIVALENT DISEASE: EVALUATION OF ANACETRAPIB LEVELS IN PLASMA AND ADIPOSE TISSUE IN PATIENTS WHO WERE PREVIOUSLY TREATED WITH ANACETRAPIB IN THE PROTOCOL 019, DEFINE STUDY
- Conditions
- -E78 Disorders of lipoprotein metabolism and other lipidaemiasDisorders of lipoprotein metabolism and other lipidaemiasE78
- Registration Number
- PER-004-14
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 2
1. Patients participating in the DEFINE, PN 019-06 study.
2. Patient has an understanding of the study procedures and agrees to participate in the study by giving written informed consent.
1. The patient has any disorder, condition, requires any medication, or is at higher risk of infection, for which the adipose biopsy procedure puts the patient at risk.
2. The patient has an allergy or sensitivity to lidocaine.
3. The patient has recently had major surgery (within last 6 months).
4. The patient has any abdominal disorders, wounds, or scars which could impact the quality of the adipose biopsy specimen.
5. Patient is taking anti-coagulants (e.g. warfarin, and factor Xa inhibitors, dabigatran).
Note: Aspirin and P2Y12 inhibitors (e.g. clopidogrel) are allowed.
6. Patient’s BMI is <20 kg/m2.
7. Patient is participating, or has participated in any other anacetrapib trial, except the PN 019 study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method