EUCTR2008-001550-41-PT进行中（未招募）不适用
A multicenter, double-blind, randomized, 12-month, placebo-controlled study to evaluate the lipid-lowering effect, safety and tolerability of AVE5530 25 mg/day and 50mg/day when added to ongoing stable statin therapy (HMG-CoA reductase inhibitors) in patients with primary hypercholesterolemia.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
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
- 性别
- All
入选标准
- •Adult patients:
- •With primary hypercholesterolemia with ongoing statin treatment at the same dose for at least 6 weeks and LDL-C levels = 100 mg/dL (2.59 mmol/L) at screening (considered insufficiently controlled)
- •With informed consent obtained
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria related to study methodology:
- •Age less than 18 years at screening
- •Administration of other investigational drugs within 30 days or 5 half lives prior to screening visit (Visit 1) (whichever comes the first)
- •Patient who previously participated in another AVE5530 trial
- •Patient who does require immediate dose escalation of statin based on investigator’s judgment
- •LDL-C levels > 250 mg/dL (6.48 mmol/L)
- •Triglycerides >350 mg/dL (3.95 mmol/L)
- •Conditions / situations such as:
- •- Patients with conditions/concomitant diseases
- •Making them non-evaluable for the primary efficacy endpoint: such as presence of any clinically significant not controlled endocrine disease known to influence serum lipids or lipoproteins. Patients on thyroid replacement therapy can be included if the dosage of thyroxine has been stable for at least 3 months prior to screening and their s-TSH sensitive TSH) levels is within ±10% of the normal ranges of the Central Laboratory.
- •Any conditions considered to be medically sound by the investigator that would limit the patient’s safe participation in the study such as: Active liver disease, as shown by but not limited to alanine aminotransferase (ALT) or aspartate amino-transferase (AST) > 3xUpper Limit Normal (ULN) range, Neutrophils < 1,500/mm3, Platelets counts < 100 000/ mm3, Unexplained CPK > 3xULN, CHD or CHD risk equivalents (10-year risk >20% based on Framingham risk score), Recent history (within 3 months of study screening and through to randomization) of moderate or severe congestive heart failure [New York Heart Association (NYHA) Class III or IV], Recent history of unstable angina pectoris, myocardial infarction, coronary bypass
- •surgery or angioplasty within 3 months of study screening, Unstable or severe peripheral artery disease within 3 months of study screening and through to randomization, Positive test for Hepatitis B surface antigen and/or Hepatitis C antibody, Known to be Human Immunodeficiency Virus (HIV) positive
- •- Presence of any other conditions (e.g. geographic, social….) actual or anticipated that the investigator feels would restrict or limit the patient’s participation for the duration of the study
- •- Patient is the Investigator or any Sub-Investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •- Administration of any lipid-lowering treatment other than the ongoing statin in the preceding 6 weeks or after the screening visit.
- •Exclusion criteria related to AVE5530 compound:
- •Pregnant or breast-feeding women,
- •Women of childbearing potential not protected by effective contraceptive method of birth control (including oral contraceptives) and/or who are unwilling or unable to be tested for pregnancy prior to exposure to the Investigational Product .
研究者
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