Dyslipidemia MedDRA version: 9.1 Level: LLT Classification code 10020604 Term: Hypercholesterolemia
Conditions
Interventions
Product Name: MK-0524A (ER-Niacin/Laropiprant) 1g/20mg
Product Code: MK-0524A (ER-Niacin/Laropiprant) 1g/20mg
Pharmaceutical Form: Tablet
INN or Propose
Sponsors
Laboratoires Merck Sharp & Dohme - Chibret
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General 1.Patient is male or female =18 years of age on day of signing informed consent. 2.Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent. 3.Contraception for female patients who are of reproductive potential: a female patient who is of reproductive potential agrees to remain abstinent or use (or have their partner use) if required locally 2 acceptable methods of birth control for the duration of the study. An acceptable method of birth control is defined as: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy. NOTE: A female patient who is not of reproductive potential is eligible without requiring the use of contraception. A female patient/subject who is not of reproductive potential is defined as: one who has either 1) reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum FSH levels in the postmenopausal range as determined by the laboratory, or 12 months of spontaneous amenorrhea), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation. NOTE: Patients are permitted to use hormonal contraceptives; however, they are not considered an acceptable form of birth control. Patients using hormonal contraceptives must agree to also use 2 acceptable methods of birth control if locally required as indicated above. Protocol-Specific 4.Patient has been on a stable dose of a protocol specified LMT (simvastatin, atorvastatin, or rosuvastatin alone or combined/coadministered with ezetimibe) for 6 weeks prior to Visit 1 and agrees to continue on the same LMT and dose for the duration of the study. NOTE: Patients taking other statins (lovastatin, pravastatin, fluvastatin), bile acid sequestrants, red yeast rice products, prescription omega-3-acid ethyl esthers (e.g., Lovaza™), fibrates or niacin = 250 mg are not eligible. 5.Patient is deemed appropriate for further lipid modification, defined as meeting one or more of the following lipid criteria: a.Elevated LDL-C defined according to NCEP ATP III risk categories as follows: •High Risk (CHD/CHD risk equivalent): =100 mg/dL (= 2.59 mmol/L) and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Patient is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day post study follow-up. 2.Patient has a history of malignancy = 5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. 3.Female patient is expecting to donate eggs during the study, including the 14-day follow-up. 4.Patient has a history or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate. 5.Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study. 6. Patient is currently participating in or has participated in a study with: an investigational compound (non-lipid-modifying) within 30 days of Visit 1, a lipid-modifying compound (investigational or marketed, including statins), within 6 weeks of Visit 1 (fibrate within 8 weeks). 7.Patient has donated and/or received blood as follows: •donated blood products or has had phlebotomy of >300 mL within 8 weeks prior to signing informed consent. •intends to give or receive blood products during the study. •intends to donate more than 250 mL of blood products within 8 weeks following the last study visit. 8.Patient has the following exclusionary laboratory values at Visit 1 (see Table 3-1 for ALT/AST/CK recommended retest guidance). •Creatinine >2.0 mg/dL (177 micromol/L) •LT (SGPT) >1.5 x ULN •AST (SGOT) >1.5 x ULN •CK >2 x ULN 9.Patient is at the time of signing informed consent, a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse. 10.Patient was 160 mm Hg or diastolic > 100 mm Hg). 12.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. 13.Patient has uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins (i.e. secondary causes of hyperlipidemia such as hyper- or hypothyroidism: 14.Patient has nephrotic syndrome or other clinically significant renal disease. 15.Patient has active peptic ulcer disease within 3 months of Visit 1. 16.Patient has had an episode of gout within 1 year of Visit 1, unless patient is currently taking allopurinol. 17.Patient has a history of hyp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: E.2.1 Main objective: To evaluate the efficacy of ER niacin/laropiprant 2g relative to placebo on plasma low-density lipoprotein cholesterol (LDL-C) at Week 12 of treatment.;Secondary Objective: To evaluate the efficacy of ER niacin/laropiprant 2g relative to placebo on plasma concentrations of LDL-C, LDL-C/HDL-C, HDL-C, TG, non-HDL-C, Apo B, Apo A-I, Total Cholesterol (TC)/HDL-C, TC, and Lp(a) at Week 12 of treatment in all patients and in certain subgroups of patients (c) To assess the percent of patients with triple control at the end of study defined as meeting the NCEP ATP-III LDL-C goal for risk category, as well as having HDL-C = 50 mg/dL (=1.29 mmol/L) for women or = 40 mg/dL (=1.04 mmol/L) for men and TG <150 mg/dL (=1.69 mmol/L) (d) To evaluate the efficacy of ER niacin/laropiprant 1 g relative to placebo on plasma concentrations of LDL-C, LDL-C/HDL-C, HDL-C, TG, non-HDL-C, and TC in all patients at Week 4 of treatment (e) To evaluate the tolerability and safety of ER niacin/laropiprant 2 g across 12 weeks of treatment.;Primary end point(s): The primary efficacy parameter is the percent change from baseline in LDL-C following 12 weeks of active treatment. | — |
Countries
Austria, France, Netherlands, Spain
Outcome results
None listed