临床试验/NCT00229970

NCT00229970已完成3 期

MK0476 Phase II/III Placebo Controlled Double Blind Study

Organon and Co0 个研究点目标入组 225 人开始时间: 2005年9月最近更新: 2022年2月2日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Organon and Co
入组人数: 225
主要终点: The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)

研究概览研究设计入排标准研究组 & 干预措施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 evaluates the efficacy and safety of MK0476 intravenous administration in adult patients with acute asthma.

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

年龄范围: 15 Years 至 65 Years（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Adult Patients With Acute Asthma Attacks

排除标准

•Patient Has Any Known Or Suspected, Acute Or Chronic Cause For Their Pulmonary Symptoms Other Than Asthma (E.G., Copd, Chronic Heart Failure, Etc.)
•Patient Has A Smoking History (20 Cigarettes Per Day) Of More Than 15 Years
•Patient Has A Disease Of The Cardiovascular, Hepatic, Renal, Hematologic Systems, Or Other Severe Disease

研究组 & 干预措施

2

Experimental

MK0476 7 mg injection

干预措施: montelukast sodium (Drug)

3

Experimental

MK0476 14 mg injection

干预措施: montelukast sodium (Drug)

结局指标

主要结局

The Time-weighted Average of Change in Forced Expiratory Volume in One Second (FEV1)

时间窗: baseline over the first 60 minutes

The Time Weighed Average Changes in Forced Expiratory Volume in One Second (FEV1) from pre-allocation baseline over the first 60 minutes after study drug administration with time interval between any measurement and the measurement prior to it is used as the weighting factor

次要结局

未报告次要终点

研究者

发起方

Organon and Co

申办方类型

Industry

责任方

Sponsor

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