Hypercholesterolemia or Low HDL-C
Conditions
Interventions
Product Name: Anacetrapib
Product Code: MK-0859
Pharmaceutical Form: Tablet
INN or Proposed INN: Anacetrapib
CAS Number: 875446-37-0
Current Sponsor code: MK-0859
Other descriptive name: ANACETRAPIB
C
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients will be eligible to continue to Visit 2 if they meet the following criteria at Visit 1: 1. Patient is male or female and =18 and =80 (or maximum age less than 80; per local regulation) years of age on day of signing informed consent. 2. A female patient should NOT be of reproductive potential. A female patient not of reproductive potential is defined as: one who has either 1) reached natural menopause defined as age 46 or older with a) 12 months of spontaneous amenorrhea or b) 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the central laboratory, 2) 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation. 3. As per NCEP ATP III CHD risk category at screening, patients are required to meet ONE of the following criteria: a. Very high risk patients (presence of established CHD or other forms of atherosclerotic vascular disease plus multiple major risk factors [e.g. diabetes], severe and poorly controlled risk factors [e.g. cigarette smoking], multiple risk factors of the metabolic syndrome [e.g. high triglycerides =200mg/dL (2.26 mmol/L) plus non-HDL-C =130 mg/dL (3.36 mmol/L) with low HDL-C 20%) with LDL-C =100 to =65 years) yes F.1.3.1 Number of subjects for this age range 157
Exclusion criteria
Exclusion criteria: Visit 1 1. Patient has previously participated in a study with a CETP inhibitor. 2. Patient has homozygous familial hypercholesterolemia. 3. Patient has a TG > 600 mg/dL (6.78 mmol/L) 4. Patient has creatine phosphokinase (CPK) >2 x upper limit of normal (ULN) [per central laboratory reference ranges]. 5. Patient has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN) [per central laboratory reference ranges]. 6. Patient has severe chronic heart failure defined by New York Heart Association (NYHA) Classes III or IV. 7. Patient has uncontrolled cardiac arrhythmias, MI, PCI, CABG, unstable angina, or stroke within three months prior to Visit 1. 8. Patient has uncontrolled hypertension defined as follows: - Sitting diastolic blood pressure =100 mmHg, or sitting systolic blood pressure =160 mm Hg (non-diabetic patients). OR - Sitting diastolic blood pressure =90 mmHg, or sitting systolic blood pressure =150 mm Hg (diabetic patients). 9. Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e., secondary causes of hyperlipidemia). Note: Patients with thyroid stimulating hormone (TSH) values outside the central laboratory normal range who are determined to be without symptoms of either hypo- or hyperthyroidism may be allowed in the study if, after review by the Investigator and Project Physician, the patient is deemed not to have clinically significant thyroid hormone excess or deficiency. 10. Patient has active or chronic hepatobiliary, hepatic or gall bladder disease. Note: Patients with chronic hepatitis B or C or non-alcoholic steatosis are allowed in the study if ALT and AST are within protocol-specified range 11. Patient has eGFR 300 mL within eight weeks of signing informed consent, or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study. 17. Patient has a history or current evidence of any condition, therapy, lab abnormality or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study, such that it is not in the best interest of the patient to participate. 18. Patient is currently taking medications that are potent inhibitors or inducers of CYP3A4 (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John’s wort) or has discontinued treatment 1 liter of grapefruit juic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placebo on plasma concentrations of LDL-C (BQ method). 2. To evaluate the efficacy of anacetrapib 100 mg for 24 weeks relative to placebo on plasma concentrations of HDL-C. 3. To evaluate the safety and tolerability of anacetrapib 100 mg for 24 weeks.;Secondary Objective: 1. To evaluate the efficacy of adding anacetrapib 100mg for 24 weeks relative to placebo on plasma concentrations of non-HDL-C. 2. To evaluate the efficacy of adding anacetrapib 100mg for 24 weeks relative to placebo on plasma concentrations of apoB. 3. To evaluate the efficacy of adding anacetrapib 100mg for 24 weeks relative to placebo on plasma concentrations of apoA-1. 4. To evaluate the efficacy of adding anacetrapib 100mg for 24 weeks relative to placebo on plasma concentrations of Lp(a). 5. To evaluate the effect of anacetrapib 100 mg on HDL-C in patients with low HDL-C at LDL-C goal after 24 weeks of treatment. 6. To evaluate the LDL-C-decreasing efficacy of anacetrapib 25 mg vs. placebo after 24 weeks of treatment. 7. To evaluate the HDL-C-increasing efficacy of anacetrapib 25 mg vs. placebo after 24 weeks of treatment. 8. To evaluate the efficacy of adding anacetrapib 25mg for 24 weeks relative to placebo on plasma concentrations of non-HDL-C. See protocol.;Primary end point(s): - LDL-C (BQ method) - HDL-C;Timepoint(s) of evaluation of this end point: - LDL-C (BQ method): at visits 3, 4, 5, 6 and 7 - HDL-C: at visits 3, 4, 5, 6 and 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - non-HDL-C - apoB - apoA-I - Lp(a) - HDL-C in patients with low HDL-C at LDL-C goal;Timepoint(s) of evaluation of this end point: - non-HDL-C: at visits 3, 4, 5, 6 and 7 - apoB: at visits 3, 4, 5, 6 and 7 - apoA-I: at visits 3, 4, 5, 6 and 7 - Lp(a): at visits 3, 6 and 7 - HDL-C in patients with low HDL-C at LDL-C goal Please see study flow chart for clearer information. | — |
Countries
Bulgaria, France, Germany, Hungary, Israel, Netherlands, Peru, Poland, Puerto Rico, Romania, Slovakia, Spain, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Operations
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Outcome results
None listed