EUCTR2011-004349-42-SE进行中（未招募）不适用
A randomized, double-blind, 12- week, parallel group, placebo-controlled study of the efficacy and safety of RO4917523 in patients with Fragile X Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 180
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
- •Adults and adolescents (14 to 50)
- •CGI-S of 3 (mildly ill) or more
- •ABC total score of 20 or more
- •Diagnosis of FXS with a confirmed FMR1 full mutation
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 60
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Have previously received treatment with another mGlu5 receptor antagonist within 18 months or RO4917523
- •Enrollment/participation in any interventional study (clinical trial) involving an investigational drug (unapproved) or non-drug treatment within the prior 3 months or 5 times the half-life (whichever is longer)
- •Any uncontrolled, unstable clinically significant psychiatric condition other than FXS that may interfere with interpretation of safety and efficacy evaluations (e.g. Attention Deficit Hyperactivity Disorder (ADHD))
- •Current symptoms or presumption of psychosis or euphoria, history of catatonia, hallucinations or delusional thoughts
- •History of suicidal behaviour or otherwise considered a high suicidal risk by the investigator
研究者
相似试验
进行中（未招募）
不适用
A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeFragile X Syndrome (FXS)MedDRA version: 14.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2011-004349-42-ESF. Hoffmann-La Roche Ltd.180
进行中（未招募）
1 期
A study of the efficacy and safety of RO4917523 in patients with Fragile X SyndromeFragile X Syndrome (FXS)MedDRA version: 14.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 100000004873EUCTR2011-004349-42-GBF. Hoffmann-La Roche Ltd.183
进行中（未招募）
不适用
A 12 week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg compared to aliskiren 300 mg in patients with Stage II hypertensiohypertensionEUCTR2008-000862-21-DEovartis Pharma Services AG660
进行中（未招募）
不适用
A 12 week, double-blind, randomized, parallel group, multicenter study to evaluate the efficacy and safety of the combination of aliskiren 300 mg and hydrochlorothiazide 25 mg compared to aliskiren 300 mg in patients with Stage II hypertension - NDhypertensionEUCTR2008-000862-21-ITOVARTIS FARMA660
进行中（未招募）
1 期
A 12-week, double-blind, randomised, parallel group, multi-centre, study to evaluate efficacy and safety of budesonide/formoterol (Symbicort® Turbuhaler®) 320/9 µg one inhalation twice daily on top of tiotropium (Spiriva®) 18 µg one inhalation once daily compared with tiotropium 18 µg one inhalation once daily, in patients with severe chronic obstructive pulmonary disease (COPD) - CLIMBSevere Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 9.1Level: LLTClassification code 10010952Term: COPDEUCTR2006-006796-21-SKAstraZeneca AB620