EUCTR2004-002591-42-ES进行中（未招募）不适用
A pharmacoeconomic study conducted in parallel with clinical trial 10200, a 24-week double-blind, risperidone-referenced, flexible dose, parallel-group extension study of bifeprunox in patients with schizophrenia
H.Lundbeck A/S0 个研究点目标入组 320 人开始时间: 2012年3月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 320
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
- •1. The patient or patient?s authorized legal representative must understand the nature of the study and must have given written informed consent.
- •2. The patient must have completed study 10199 immediately prior to enrolment into the extension study.
- •3. On the basis of a physical examination, medical history, electrocardiogram, blood biochemistry, haematology tests and a urinalysis carried out at the Termination Visit of study 10199, the patient is, in the investigator?s opinion, otherwise healthy.
- •4. A female patient of child-bearing potential may be enrolled provided that she:
- •b. has a negative pregnancy test (blood serum beta-HCG) prior to Visit 1 (= Termination Visit of study 10199), and
- •c. is routinely using one of the following medically acceptable methods of birth
- •i. oral contraception at a stable dose for at least 3 months prior to entry into the study
- •ii. the first dose of medroxyprogesterone or other i.m. injection administered at least 2 months prior to entry into the study, and has been maintaining the recommended administration schedule.
- •iii. implementation of levonorgestrel system or an inta-uterine device for at least 2 months prior to entry into the study
- •iv. barrier methods (combination of diaphragm and spermicidal or condom and spermicide) prior to and during the trial, and
- •c. is not breast feeding, and
- •d. agrees not to become pregnant during the trial
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Patients meeting any of the exclusion criteria applying for patients at entry to study 10199, except for exclusion criteria 19 (hospitalisation for the current episode for more than four weeks), 23 (need for continuous treatment with anticholinergic drugs), 24 (exposure to any investigational drug within 60 days prior to study entry), and 26 (prior exposure to bifeprunox), cannot be included in the study
研究者
相似试验
已完成
1 期
An interventional study to evaluate the effects of formulation and dose on the Pharmacokinetics (PK, the measure of how the human body prcessed a substance) of up to four Donezepil Transdermal Delivery System (TDS, a patch that delivers a drug) formulations (50 cm2 patch size), worn for seven days, applied to the backs of healthy female participants.Alzheimer’s DiseaseNeurological - Alzheimer's diseaseACTRN12616000348459INCResearch Australia Pty Ltd24
进行中（未招募）
1 期
This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA). This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid arthritisEUCTR2013-005543-90-DEAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 on the human body , and what effects investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.MedDRA version: 20.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersRheumatoid ArthritisEUCTR2013-005543-90-EEAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.Rheumatoid arthritisEUCTR2013-005543-90-BGAmgen Inc300
进行中（未招募）
1 期
This trial is designed to determine the effects the investigational medicine, ABP 798 has on the human body , and what effects the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe rheumatoid arthritis (RA).This study will assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.Rheumatoid arthritisEUCTR2013-005543-90-PLAmgen Inc300