Sub-study to Evaluate the Effect of An Oral Dose of Tyramine in Subjects Completing 26 Weeks of Participation in PRESTO (TVP-1012/133)

Teva Branded Pharmaceutical Products R&D, Inc.0 个研究点目标入组 55 人开始时间: 2000年10月1日最近更新: 2011年4月12日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Teva Branded Pharmaceutical Products R&D, Inc.
入组人数: 55
主要终点: An increase in systolic blood pressure of > 30mmHg from the mean baseline value (documented by at least 3 consecutive measurements). Or Bradycardia with a heart rate below 40 beats per minute

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is to determine if Tyramine has any side effects on patients receiving 0.5mg, 1mg of Rasagiline or Placebo

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Men and women with idiopathic Parkinson's disease (PD) who have met inclusion criteria for PRESTO, and have completed the 26-week PRESTO study. The subject should be available to participate in the sub-study immediately following the last PRESTO visit (same day). Subjects must continue PRESTO study drug until the morning of the Tyramine Sub-Study.
•Subjects must provide separate informed consent to participate in the Tyramine Sub-Study.

排除标准

•Subjects must not have a history of intracranial aneurysm or stroke.
•Subjects should not have uncontrolled hypertension, defined as systolic pressure > 160 mmHg, or diastolic pressure > 90 mmHg.

结局指标

主要结局

An increase in systolic blood pressure of > 30mmHg from the mean baseline value (documented by at least 3 consecutive measurements). Or Bradycardia with a heart rate below 40 beats per minute

时间窗: 26 weeks

次要结局

未报告次要终点

研究者

发起方

Teva Branded Pharmaceutical Products R&D, Inc.

申办方类型

Industry

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