临床试验/NCT00418613

NCT00418613已完成2 期

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions of MK0633 in Patients With COPD

Merck Sharp & Dohme LLC0 个研究点目标入组 266 人开始时间: 2008年1月最近更新: 2015年9月3日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 266
主要终点: Pulmonary function test data

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

A clinical study to evaluate the efficacy and safety of MK0633 in patients with Chronic Obstructive Pulmonary Disease (COPD).

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: 40 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Documented COPD defined by clinical history and spirometry, with symptoms including dyspnea, wheezing, chest tightness, cough, sputum production, or nocturnal awakening
•Male or postmenopausal females 40 -75 years of age

排除标准

•Impaired renal function
•History of chronic liver disease or persistent liver function test (LFT) abnormalities
•History of recent cardiovascular clinical event
•Evidence of another clinically significant, active pulmonary disorder such as bronchiectasis or asthma

研究组 & 干预措施

1

Experimental

MK0633

干预措施: MK633 (Drug)

结局指标

主要结局

Pulmonary function test data

时间窗: Measured over 12 weeks

次要结局

Overall daytime symptoms score, total daily beta agonist use, and Chronic Respiratory Disease Questionnaire (CRQ) score(Measured over 12 weeks of treatment)

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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