Dyslipidemia
Conditions
Interventions
Trade Name: TREDAPTIVE,
Product Name: Tredaptive
Product Code: MK-0524A
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Laropiprant
Other descriptive name: MK-0524
Concentration unit
Sponsors
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient must meet one of the following criteria based on NCEP ATP III risk categorization: • High risk (CHD or CHD risk equivalents, including diabetes and Framingham study 10-year risk of CHD >20%) on a statin with LDL-C =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria: • Patient is poorly controlled (HbA1C >8.5% at Visit 1) • Patient is newly diagnosed (within 3 months of Visit 1) • Patient has recently experienced repeated hypoglycemia or unstable glycemic control. • Patient is taking new or recently adjusted antidiabetic pharmacotherapy (with the exception of ±10 units of insulin) within 3 months of Visit 1. 2. Patient is currently taking or has taken niacin >50 mg once daily within 6 weeks of visit 1. 3. Patient is taking a statin (or statin containing product) and fibrate concomitantly at Visit 1 4. Patient is taking Aspirin greater than 100mg per day at Visit 1. Patient has chronic heart failure defined by the New York Heart Association (NYHA) Classes III or IV, uncontrolled cardiac arrhythmias, or poorly controlled hypertension (systolic blood pressure >160 mm Hg or diastolic >100 mm Hg) 5. Patient has arterial bleeding 6. Patient is chines and is on simvastatin 80 mg or a product containing simvastatin 80 mg at Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective: Assess the effects of ERN/LRPT relative to ERN on flushing during the post-withdrawal dosing period as measured by number of days/week with GFSS >4 during weeks 21 to 32. ;Secondary Objective: Secondary objectives: • Assess the effects of ERN/LRPT relative to ERN on flushing during the post-withdrawal dosing period as measured by percentage of patients with maximum GFSS =4 during weeks 21 to 32. • Assess the safety and tolerability of ERN/LRPT relative to PBO. ;Primary end point(s): • Number of days per week with GFSS>4 during weeks 21 to 32. | — |
Countries
Austria, Denmark, Finland, France, Germany, Spain, Sweden
Outcome results
None listed