EUCTR2007-001921-86-GB进行中（未招募）1 期
A double-blind, placebo-controlled, parallel-group, multi-center study to investigate the effect of Omacor? (n-3 PUFA) on lipid parameters in HIV infected patients treated with HAART
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
- 65
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
- •1. Subjects = 18 years of age
- •2. Documented HIV-infection
- •3. On HAART for the last 3 months
- •4. Written informed consent
- •5. Plasma triglycerides values between 200 mg/100 ml and 1000 mg/100 ml
- •6. Fibrate treatment that has been ongoing for at least 3 months prior to randomization is considered acceptable
- •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
- •1. Age below 18 years
- •2. Other malign disease
- •3. Subjects assessed to be not compliant with study
- •4. Females must be non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal-ligation or at least one year postmenopausal) or if of childbearing potential, agree to practice effective barrier contraceptive methods, use an intrauterine device (IUD) or use birth-control pills or equivalent injectable contraceptive. The subjects must have been practicing the selected method of birth control for at least 3 months prior to visit 1.
- •5. Subjects taking fish oil capsules 8 weeks prior to inclusion in this study
- •6. Known allergy to fish oil or soy
- •7. Treatment with statins which can not be stopped
- •8. Treatment with oral anti-coagulants
- •9. Subjects with an increase risk of bleeding
研究者
相似试验
进行中（未招募）
不适用
A double-blind, placebo-controlled, parallel-group, multi-center study to investigate the effect of Omacor? (n-3 PUFA) on lipid parameters in HIV infected patients treated with HAARTHAART-induced hypertriglyeridemia in HIV infected subjectsMedDRA version: 9.1Level: LLTClassification code 10020869Term: HypertriglyceridaemiaEUCTR2007-001921-86-DESolvay Pharmaceuticals GmbH65
进行中（未招募）
1 期
A safety and efficacy study of pregabalin in children 4-16 years of age with partial onset seizurepartial onset seizuresMedDRA version: 14.1Level: LLTClassification code 10034089Term: Partial seizures NOSSystem Organ Class: 10029205 - Nervous system disordersEUCTR2010-020852-79-ITPFIZER INC.153
进行中（未招募）
不适用
A study to determine the safety, tolerability and efficacy of AMAP102 compared to placebo in patients with osteoarthritisMedDRA version: 16.1Level: LLTClassification code 10019115Term: Hand osteoarthritisSystem Organ Class: 100000004859MedDRA version: 16.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859OsteoarthritisEUCTR2012-001769-34-SEAnaMar AB120
进行中（未招募）
不适用
A study to determine the safety, tolerability and efficacy of AMAP102 compared to placebo in patients with osteoarthritisOsteoarthritisEUCTR2012-001769-34-DEAnaMar AB120
进行中（未招募）
不适用
A double-blind, placebo-controlled, parallel group, proof of concept trial to assess the tolerabiltiy, safety and efficacy of rotigotine nasal spray for the acute treatment of 'off' symptoms in subjects with advanced-stage, idiopathic Parkinson's diseaseadvanced-stage, idiopathic Parkinson's diseaseMedDRA version: 8.1Level: LLTClassification code 10061536EUCTR2005-004290-19-DESchwarz Biosciences GmbH100