A 2-YEAREXTENSION TO: A76-WEEK, WORLDWIDE, MULTICENTER, DOUBLE.BLIND, RANDOMIZED, PALCEBO-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.
- Registration Number
- PER-038-10
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 31
1.Patient has completed the P019-base study
including the reversibility period (i.e. 12 or to up to 24 weeks).
2.Patient is son statin therapy ± lipid-modifying
therapy since the end of the base study and planning to continue taking a statin throughout the study.
3.Patient has an understanding of the study
procedures and agrees to participate in the extension study by giving written informed consent.
4.A patient who is of reproductive potential agrees
to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, condom, vasectomy, and hormonal contraception.
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 is currently participating in a study with
another investigational drug.
3.Patient i son or likely to require prohibited
medication.
4.Patient has exclusionary laboratory values at
their most recent clinic visit of the base study:
•CPK (creatinine phosphokinase)>2 x upper limit
of normal (ULN) [per central laboratory reference range].
•ALT (alanine aminotransferase) or AST
(aspartate aminotransferanse)>2 x ULN [per central laboratory reference range].
•eGFR<30 ml/min/1.73m2 based on MDRD
(Modification of Diet in Renal Disease] equation, nephritic syndrome , or other clinically significant renal disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method