EUCTR2006-006434-17-RO进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 644
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
- •Subject must have the capacity to consent and must have signed the study informed consent document indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study
- •Man or woman 18 years of age (or the minimum age to provide informed consent in the jurisdiction in which the study is taking place, whichever is older).
- •Met diagnostic criteria for schizophrenia according to DSM IV (disorganized type [295.10], catatonic type [295.20], paranoid type [295.30], residual type [295.60] or undifferentiated type [295.90]) for at least 1 year before screening
- •A total PANSS score at screening of between 70 and 120, inclusive and at baseline of between 60 and 120, inclusive
- •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
- •Primary active DSM-IV Axis I diagnosis other than schizophrenia
- •Subjects who are unable to provide their own consent or who have been involuntarily committed to psychiatric hospitalization
- •DSM-IV diagnosis of active substance dependence within 3 months before the screening evaluation (nicotine and caffeine dependence are not exclusionary)
- •History of treatment resistance as defined by failure to respond to 2 adequate studies of different antipsychotic medications; an adequate study is defined as a minimum of 4 weeks at the subject’s maximum tolerated dose·
- •Treatment with any of the following disallowed therapies:
- •-LAI antipsychotic (including RISPERDAL CONSTA) within 2 injection cycles before screening
- •-ECT within 60 days before screening
- •-Currently taking 3 or more antipsychotic medications
- •-Use of clozapine within 60 days before screening
- •-Use of aripiprazole within 2 weeks before baseline
- •-Nonselective or irreversible MAOI antidepressants within 4 weeks before screening
- •-Other antidepressants unless subject has been on a stable dose for at least 30 days before screening (if less than 30 days and subject does not require the antidepressant it may be washed out before the baseline visit; if less than 30 days and subject requires antidepressant treatment, the subject should not be included in the study)
- •-Mood stabilizers including lithium and all anticonvulsants within 4 weeks of screening
- •-Beta-blockers, within 4 weeks of screening, unless used for control of hypertension and subject's blood pressure has been stabilized (see Section 8.1, Allowed Concomitant Medications)
研究者
相似试验
进行中（未招募）
1 期
A trial to assess the safety and efficacy of UX007 in patients with Glucose Transporter Type 1 Deficiency Syndrome (Glut1 DS)Glucose Transporter Type 1 deficiency syndromeMedDRA version: 17.1 Level: HLGT Classification code 10039911 Term: Seizures (incl subtypes) System Organ Class: 10029205 - Nervous system disordersEUCTR2013-003771-35-GBltragenyx Pharmaceutical Inc36
进行中（未招募）
1 期
Safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (liver disease) from nonalcoholic steatohepatitis (NASH).Compensated Cirrhosis from Nonalcoholic Steatohepatitis (NASH)MedDRA version: 20.0Level: HLTClassification code 10019669Term: Hepatic fibrosis and cirrhosisSystem Organ Class: 100000004871MedDRA version: 20.1Level: LLTClassification code 10064844Term: Compensated cirrhosisSystem Organ Class: 100000004871EUCTR2019-003932-22-DEBristol-Myers Squibb International Corporation270
进行中（未招募）
不适用
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of Fluticasone Furoate Nasal Spray 110mcg in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)Perennial Allergic Rhinitis (PAR) in adults and children of 12 years and older.MedDRA version: 9.1Level: LLTClassification code 10034382Term: Perennial allergic rhinitisEUCTR2007-006562-15-EEGlaxoSmithKline Research & Development Ltd288
进行中（未招募）
1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily, Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 4 Weeks in Adult and Adolescent Subjects (12 years of age and older) with Vasomotor/Idiopathic RhinitisVasomotor/Idiopathic RhinitisEUCTR2004-004744-43-NOGlaxoSmithKline Research & Development Ltd347
进行中（未招募）
1 期
Baricitinib in Patients with COVID-19 InfectioCOVID-19 infectionMedDRA version: 23.0Level: PTClassification code 10051905Term: Coronavirus infectionSystem Organ Class: 10021881 - Infections and infestationsEUCTR2020-001517-21-DEEli Lilly and Company1,400