A Multicenter, Double-Blind, Flexible-Dose, 6-Month Extension Trial Comparing the safety and Efficacy of Asenapine With Olanzapine in Subjects who Completed Protocol 25543 - Aphrodite extension

V Organon0 个研究点目标入组 380 人开始时间: 2005年11月9日最近更新: 2019年6月30日

研究概览

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•1. sign written informed consent after the scope and nature of the investigation have been explained. Subjects unable or incapable of signing may participate if a legally authorized representative provides consent and the subject affirms their participation;
•2. have completed the 25543 trial, and would benefit from continued treatment according to the investigator’s judgment;
•3. have demonstrated an acceptable degree of compliance with trial medication in the 25543 trial in the opinion of the investigator; and
•4. continue to meet all demographic and procedural inclusion criteria of the 25543 trial upon entry into this extension 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1. have an uncontrolled, unstable clinically significant medical condition (e.g., renal, hepatic, endocrine, respiratory, cardiovascular, hematologic, immunologic, cerebrovascular disease, anorexia (body mass index [BMI] <18.5] or obesity (BMI >35) or malignancy that may interfere with the interpretation of safety or efficacy evaluations in the opinion of the investigator;
•2. have any clinically significant abnormal laboratory, vital sign, physical examination, or ECG findings, in the opinion of the investigator, may interfere with the interpretation of safety or efficacy evaluations;
•3. have a positive result on the serum pregnancy test or are breastfeeding at end of trial EOT (Day 182 of study 25543)/baseline protocol 25544), or intend to become pregnant during the course of the trial;
•4. require high doses of benzodiazepines (=4 mg per day lorazepam or equivalent) or for more than 4 days per week;
•5. require partial benzodiazepine agonists (zolpidem, zaleplon, or zopiclone) for the treatment of insomnia for more than 4 days per week, or above the allowable dose per protocol;
•6. have been judged by the principal investigator to be medically non-compliant in the management of their disease; or
•7. present an imminent risk of self-harm or harm to others.

发起方

V Organon