None listed
Conditions
Interventions
Patients completing the P019base study will directly enter the extension study when the extension study is implemented at the site. Thus the following 2 tyopes of patients from the base atudy are eleg
Sponsors
MERCK SHARP & DOHME PERU S.R.L.,
Eligibility
Sex/Gender
All
Age
20 Years to 82 Years
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Contacts
Public ContactStela Lopez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed