A 26-Week Extension to a 26-Week Treatment, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Adaptive, Seamless, Parallel-Group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease

ovartis Healthcare Pvt Ltd0 个研究点目标入组 418 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE)
•In addition the following inclusion/exclusion criteria specified below must be met.
•Patients must complete Stage 2 of the core study B2335S.
•Written informed consent to participate in the extension must be obtained.
•Patients must be able to comply with all study requirements.

•*Patients who were randomized to open-label tiotropium in Study B2335S.
•* Patients who participated in Stage 1 of the core study (B2335S).
•*Patients discontinued irrespective of the reason from Stage 2 of the core study.
•*Patients who fail to comply with the core protocol requirements and procedures.
•*Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
•*Patients who in the Investigator's opinion should not-participate in the extension study.

发起方

ovartis Healthcare Pvt Ltd