JPRN-jRCT2080220742已完成2 期
A Phase 2, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm, Dose-comparison Trial of OPC-6535 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 772
研究概览
简要总结
The results of this trial have established a treatment effect for OPC-6535 12.5 mg. There are no findings from this investigation that raise serious concerns about future administration of OPC-6535 to humans.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 40age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •Age 40 to 75 years, inclusive, at the time informed consent is obtained
- •-Ability to provide own written informed consent
- •-Agree to use an appropriate method of contraception until 3 months after the last dose of the investigational medicinal product (IMP)
- •-A rating of 1 or higher on the Goddard scale in assessment of emphysema severity by chest CT scan at screening
- •-Ratio of forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC) of less than 70% at screening
- •-Cigarette smoking history of at least 20 pack years at screening
排除标准
- •-Subjects with obstructive disorders due to bronchial asthma
- •-Subjects receiving long-term oxygen therapy
- •-Subjects with active tuberculosis or obvious bronchiectasis
- •-Complication of malignant tumor
- •-Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders
- •-Uncontrolled condition with COPD exacerbation of level 2 or 3 within 8 weeks prior to the start of washout period (within 12 weeks prior to start of treatment period)
研究者
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