EUCTR2017-000216-42-IE进行中（未招募）1 期
A multi-center, double-blind, placebo-controlled, Phase 3b study in patients with pulmonary arterial hypertension to assess the effect of selexipag on daily life physical activity and patient’s self-reported symptoms and their impacts - TRACE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female between 18 and 75 years old inclusive.
- •- Women of childbearing potential must have a negative serum
- •pregnancy test at planned visits and use an acceptable method of birth control from screening up to 30 days after study treatment
- •discontinuation.
- •- Symptomatic PAH belonging to one of the following subgroups only:
- •. Idiopathic
- •. Heritable
- •. Drug or toxin induced
- •. Associated with one of the following: connective tissue disease; HIV
- •infection; corrected simple congenital heart disease.
- •- With the following hemodynamic characteristics assessed by right
- •heart catheterization (RHC) prior to randomization:
- •. Mean pulmonary artery pressure (mPAP) = 25 mmHg
- •. Pulmonary vascular resistance (PVR) = 240 dyn•sec/cm5 (or 3 Wood Units)
- •. Pulmonary artery wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) = 15 mmHg.
- •- Treatment with an endothelin receptor antagonist (ERA) for at least
- •90 days and on a stable dose for 30 days prior to randomization.
- •- Possible treatment with a Phosphodiesterase-5 inhibitor or sGC
- •stimulator must be ongoing for at least 90 days and on a stable dose for 30 days prior to randomization.
- •- WHO functional class (FC) II or III at randomization.
- •- 6-minute walk distance (6MWD) = 100 m at screening.
- •- Ability to walk without a walking aid.
- •- Valid baseline data for daily life physical activity (DLPA) and PAH-SYMPACT®.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •- Patients on a PAH-specific monotherapy targeting the nitric oxide
- •pathway (i.e. PDE-5 inhibitor or sGC stimulator).
- •- Patients treated with prostacyclin, prostacyclin analog or selexipag at any time prior to Day 1.
- •- Any hospitalization during the last 30 days prior to screening (Visit 1).
- •- Severe coronary heart disease or unstable angina.
- •- Documented severe hepatic impairment or severe renal insufficiency at screening (Visit 1).
- •- Participation in a cardio-pulmonary rehabilitation program based on
- •exercise training within 8 weeks prior to screening.
- •- Any factor or condition likely to affect full participation in the study or compliance with the protocol (such as adherence to protocol mandated procedures), as judged by the investigator.
研究者
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