NCT02191137已完成4 期
A Phase IV, Prospective, Single-Arm, Open-Label Study to Measure Outcomes in Patients With Pulmonary Arterial Hypertension Not on Active Treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 75
- 主要终点
- Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score
研究概览
简要总结
The MOTION study was a prospective, Phase IV study for patients with Pulmonary Arterial Hypertension (PAH). The study was designed to further explore patient-reported outcomes in PAH subjects who were not on active treatment and living in the United States. In addition, the study explored the use of new telemetric technology (Accelerator band) to evaluate if this technology correlates with improvements in 6 Minute Walking Distance 6MWD in patients with PAH.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, 18 to 80 years of age at Visit 0
- •Women of childbearing potential must have a negative pre-treatment pregnancy test, negative monthly pregnancy test, and must use reliable methods of contraception according to the Risk Evaluation Mitigation Strategies (REMS) guidance
- •Symptomatic pulmonary arterial hypertension, World Health Organization Group 1 with a pulmonary vascular resistance (PVR) >300 dyn*sec*cm-5, mean pulmonary artery pressure (PAP mean) ≥25 mmHg, and pulmonary capillary wedge pressure (PCWP) ≤15 mmHg as assessed by right heart catheterization within 6 months prior to Screening (Visit 0)
- •PAH of the following types:
- •Idiopathic (IPAH) Familial (FPAH)
- •Associated with PAH (APAH) due to:
- •Connective tissue disease Congenital heart disease, but only if patient underwent surgical repair more than one year before enrollment Anorexigen or amphetamine use Portal hypertension with liver cirrhosis
- •Not treated with PAH-specific pulmonary medications within 14 days of Screening (Visit 0)
- •6MWD between 150 meters and 450 meters
排除标准
- •Patients who are pregnant
- •Patients currently on nitrate and/or nitric oxide (NO) donor therapy; patients currently taking phosphodiesterase 5 (PDE5) inhibitors (such as sildenafil, tadalafil, vardenafil) and non-specific PDE inhibitors (theophylline, dipyridamole)
- •Non-WHO group 1 Pulmonary Hypertension
- •Severe restrictive lung disease
- •History of uncontrolled high blood pressure or hypotension
- •A medical disorder, condition, or history that in the opinion of the Investigator would impair their ability to participate or complete this study
- •Active state of hemoptysis or pulmonary hemorrhage, including those events managed by bronchial artery embolization
研究组 & 干预措施
Riociguat 0.5mg to 2.5 mg
Experimental
Single arm, open label
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
结局指标
主要结局
Change From Baseline to Week 24 in the Living With Pulmonary Hypertension (LPH) Questionnaire Total Score
时间窗: Baseline to Week 24
The Living with Pulmonary Hypertension (LPH) questionnaire with Heart Failure questionnaire comprises 21 items, responded to on a 6-point Likert scale ranging from 0 'No' to 5 'Very much'. A total score ranging from 0 (best) to 105 (worst) is calculated by summing the responses to all 21 questions.
次要结局
- Percentage of Patients With an MCID From Baseline in LPH Emotional Dimension Score at Weeks 4, 16, and 24(Baseline to Week 4, Week 16 and Week 24)
- Percentage of Patients With an MCID From Week 16 in Physical Dimension Score at Week 24 (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Week 16 to Week 24 in the WHO Functional Class (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Baseline to Weeks 16 and 24 in the 6MWD(Week 16 to Week 24)
- Change From Baseline to Weeks 4 and 16 in the LPH Total Score(Baseline to Week 4 and Week 16)
- Change From Baseline to Weeks 4, 16, and 24 in the LPH Physical Dimension Score(Baseline to Weeks 4, 16, and 24)
- Change From Week 16 to Week 24 in the LPH Total Score (Completers Analysis Set Only)(Week 16 to Week 24)
- Percentage of Patients With an MCID From Week 16 in LPH Total Score at Week 24 (Completers Analysis Set Only)(Week 16 to Week 24)
- Percentage of Patients With an MCID From Week 16 in Emotional Dimension Score at Week 24 (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Baseline to Weeks 4, 16, and 24 in the WHO Functional Class(Baseline to Week 4, Week 16 and Week 24)
- Change From Baseline to Weeks 16 and 24 in the Modified Borg Dyspnea Scale(Week 16 to Week 24)
- Change From Week 16 to Week 24 in the LPH Physical Dimension Score (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Baseline to Weeks 4, 16, and 24 in the LPH Emotional Dimension Score(Baseline to Week 4, Week 16 and Week 24)
- Change From Week 16 to Week 24 in the LPH Emotional Dimension Score (Completers Analysis Set Only)(Week 16 to Week 24)
- Percentage of Patients With a Minimal Clinically Significant Important Difference (MCID) From Baseline in LPH Total Score at Weeks 4, 16, and 24(Baseline to Week 4, Week 16 and Week 24)
- Percentage of Patients With an MCID From Baseline in LPH Physical Dimension Score at Weeks 4, 16, and 24(Baseline to Week 4, Week 16 and Week 24)
- Change From Baseline to Weeks 4, 16, and 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands and Output Demands Scores(Baseline to Week 4, Week 16 and Week 24)
- Change From Baseline to Weeks 4, 16, and 24 in the WLQ Percentage of Productivity Loss(Baseline to Week 4, Week 16 and Week 24)
- Change From Week 16 to Week 24 in the WLQ Time Management, Physical Demands, Mental-Interpersonal Demands, and Output Demands Scores (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Week 16 to Week 24 in the WLQ Percentage of Productivity Loss (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Baseline to Weeks 4, 16, and 24 in the Short Form-12 Health Survey (SF-12) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Score(Baseline to Week 4, Week 16 and Week 24)
- Change From Week 16 to Week 24 in the SF-12 PCS Score and MCS Score (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Week 16 to Week 24 in the Modified Borg Dyspnea Scale (Completers Analysis Set Only)(Week 16 to Week 24)
- Change From Week 16 to Week 24 in the 6MWD (Completers Analysis Set Only)(Week 16 to Week 24)
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