NCT01062282已完成不适用
VENIS - Prospective Observational Study of Ventavis® Inhalation Therapy in the Treatment of Patients With Pulmonary Arterial Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 41
- 主要终点
- The primary efficacy variable is 6-minute walking distance
研究概览
简要总结
The purpose of this study is to gain information on safety and efficacy from Korean patients who starting Ventavis treatment by observational method.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The treating physician has chosen Ventavis as a suitable treatment for the patient
- •Patient with PH and classified as NYHA functional class III or IV and WHO group 1
排除标准
- •Any condition that prevents participation in the study, including pregnancy and other contraindications for Ventavis treatment (as listed in the current Ventavis patient package insert).
研究组 & 干预措施
Group 1
干预措施: Iloprost (Ventavis BAYQ6256) (Drug)
结局指标
主要结局
The primary efficacy variable is 6-minute walking distance
时间窗: At baseline and month 1,3,6 for an observational period of 6 months
次要结局
- New York Heart Association functional class(Baseline, month 1,3,6)
- PH-related symptoms and change of concomitant medication(Baseline, month 1,3,6)
- Hemodynamic parameters(If applicable ( at any time during Ventavis treatment))
- Adverse Event collection(If applicable (during the study period))
研究者
相似试验
已完成
不适用
Safety and Effectiveness of Nintedanib in Korean PatientsIdiopathic Pulmonary FibrosisNCT04525547Boehringer Ingelheim70
尚未招募
不适用
A Prospective Multicenter Pivotal Study to Evaluate Safety and Effectiveness of Venus-Neo Surgical Aortic ValveAortic Valve DiseaseCardiovascular DiseasesNCT05941455Jilin Venus Haoyue Medtech Limited155
已完成
不适用
Post-Marketing Surveillance of Ventavis® in Chinese Patients With Primary Pulmonary Hypertension (PPH)Primary HypertensionNCT00882947Bayer38
已完成
不适用
A Regulatory Requirement Non Interventional Study to Monitor Safety and Effectiveness of Trajenta Duo in Type 2 Diabetes Patients in KoreaDiabetes Mellitus, Type 2NCT01903356Boehringer Ingelheim724
招募中
不适用
Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the BodyLocally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene FusionNCT04142437Bayer150