A single-center, double-blind, randomized, placebo-controlled, 13-week study to evaluate the efficacy and safety of one capsule of XTEND-LIFE compared to placebo, and an extended four-week trial to assess its benefit when combined with ezetimibe 10 mg per day

Connecticut Clinical Research LLC (USA)0 个研究点目标入组 60 人开始时间: 2006年4月27日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Men and women greater than 18 years of age with LDL-C greater than or equal to 130 mg/dl
•2. Have not received any cholesterol lowering medication for 8 weeks
•3. Patients with coronary heart disease or coronary heart disease risk equivalents and with documented intolerance or reluctance to take Hydroxamethylglutaryl-CoA (HMG-CoA) reductase inhibitors will be included, however, patients being treated with and who are tolerant of HMG-CoA reductase inhibitors will not be considered

•1. Plasma triglycerides >400 mg/dl
•2. Congestive Heart Failure (CHF) with New York Heart Association (NYHA) class 3 or 4
•3. Hemoglobin A1C >9%
•4. Ileal bypass or gastrointestinal (GI) disorder that can impair absorption of study drugs
•5. Impaired renal function - aspartate aminotransferase (AST) or alanine transaminase (ALT) >2 times the upper limit of normal
•6. Uncontrolled endocrine disorder
•7. Alcohol consumption >14 drinks per week
•8. Lipid lowering medication within 8 weeks
•9. Treatment with oral corticosteroids, immunosuppressants, androgens or warfarin

发起方

Connecticut Clinical Research LLC (USA)