EUCTR2010-021627-27-GB进行中（未招募）1 期
A Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo-Controlled 12-Week Study to Evaluate the Efficacy and Safety of Extended Release (ER) Niacin/Laropiprant When Added to Ongoing Lipid-Modifying Therapy in Patients with Primary Hypercholesterolemia or Mixed Dyslipidemia
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,224
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Protocol-Specific:
- •1. Patient has a history of primary hypercholesterolemia or mixed dyslipidemia.
- •2. Patient must meet one of the following risk categories and corresponding LDL-C criteria (detailed definitions of risk categories are in Appendix 6.1) at Visit 2.
- •Risk Category: Very High Risk
- •Criteria: Established CHD or other atherosclerotic vascular disease + other significant or multiple risk factors
- •Acceptable LDL-C Value (Visit 2):=70 to <130 mg/dL; =1.81 to <3.36 mmol/L
- •Risk Category: High Risk:
- •Criteria: One of the following:
- •-CHD risk equivalent
- •Acceptable LDL-C Value (Visit 2):=100 to <130 mg/dL; =2.59 to <3.36 mmol/L
- •Risk Category: Moderate Risk
- •Criteria: Non-CHD/Non-CHD Risk Equivalent patient with =2 risk factors and Framingham 10-year CHD risk =20%
- •Acceptable LDL-C Value (Visit 2): =130 to <160 mg/dL; =3.36 to <4.14 mmol/L
- •3. Patient has TG levels <500 mg/dL (<5.65 mmol/L) at Visit 2.
- •4. Patient has been on a stable dose of one of the following LMTs for at least 6 weeks prior to Visit 1, and agrees to remain on the same type and dose of LMT for the duration of the study, unless the patient is LMT naive. Patient who is given new therapy (ezetimibe/simvastatin FDC tablet 10/20 mg or rosuvastatin 10 mg or ezetimibe co-administered with any statin) based on investigator’s clinical judgment at Visit 1, must agree to remain on the same type and dose of LMT for the duration of
- •-Monotherapy: any statin
- •-Combination Therapy: ezetimibe/simvastatin FDC tablet
- •-Co-administration Therapy: any statin co-administered with ezetimibe
- •5. Patient is male or female and =18 years of age on day of signing informed consent.
- •6. A female patient must meet ONE of the following:
- •a. Of reproductive potential and agrees to remain abstinent or use (or have their partner use) 2 acceptable methods of birth control for the study duration. An acceptable method of birth control is defined as:
- •- intrauterine device (IUD)
- •- diaphragm with spermicide
- •- vasectomy
- •- oral contraceptive pills (OCPs) – must have been used for at least 2 months prior to randomization.
- •- contraceptive sponge (with spermicide) is acceptable as a single method of birth control but requires one of the following as a second method: intrauterine device (IUD), diaphragm, condom or vasectomy.
- •b. Not of reproductive potential is eligible without requiring the use of contraception.
- •Definition of not of reproductive potential: one who has either of the
- •- reached natural menopause, defined as: 6 months of spontaneous amenorrhea with serum FSH levels (at Visit 1) in the postmenopausal range (per central lab) or 12 months of spo
排除标准
- •Protocol-Specific:
- •1. Patient has taken a prohibited LMT within 6 weeks of Visit 1. Examples of prohibited LMT include bile acid sequestrants, fibrates (monotherapy, coadministration or combination with other LMT), niacin >50 mg, and red yeast rice products.
- •2. Patient has had a change to the type or dose of acceptable LMT regimen within 6 weeks of Visit 1.
- •3. Patient is pregnant, breastfeeding, or expecting to conceive during the study including the 14-day poststudy follow-up.
- •4. 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
- •5. Female patient is expecting to donate eggs during the study, including the 14-day follow-up.
- •6. Patient is unlikely to adhere to the study procedures, keep appointments, or is planning to relocate during the study.
- •7. Patient has participated in a study, including post-study follow-up, with an investigational compound (non-lipid-modifying) within 30 days of Visit 1 or a lipidmodifying compound (investigational or marketed), within 6 weeks of Visit 1.
- •8. 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.
- •9. Patient has the following exclusionary laboratory values at Visit 2 (Table 3-1 provides retesting guidelines).
- •- Creatinine clearance (eGFR) <30 mL/min (0.50 mL/s)
- •- ALT (SGPT) >1.5 x ULN
- •- AST (SGOT) >1.5 x ULN
- •- CK >2 x ULN
- •10. Patient has used recreational or illicit drugs within 1 year of signing informed consent.
- •11. Patient was <80% compliant with LMT or placebo at Visit 2, AND in the opinion of the investigator, is believed to be unable to maintain at least 80% compliance with dosing during the active treatment period.
- •Prohibited Medical Conditions
- •12. 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).
- •13. Patient has Type 1 or Type 2 diabetes mellitus and meets one or more of the following criteria:
- •- Patient is poorly controlled (HbA1C >8.0% at Visit 1)
- •- Patient is newly diagnosed (within 3 months of Visit 1)
- •- Patient has recently experienced repeated hypoglycemia or unstable glycemic control (within 3 months of Visit 1).
- •- Patient is taking new or recently adjusted antidiabetic pharmacotherapy (with the
- •exception of ± =?10 units of insulin) within 3 months of Visi
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