NCT04435782终止4 期
A Prospective, Multicenter, Single-Arm, Open-Label, Phase 4 Study of the Effects of Selexipag on Right Ventricular Remodeling in Pulmonary Arterial Hypertension Assessed by Cardiac Magnetic Resonance Imaging
Actelion35 个研究点 分布在 15 个国家目标入组 9 人开始时间: 2021年7月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 35
- 主要终点
- Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
研究概览
简要总结
The purpose of the study is to assess the effects of selexipag on right ventricular (RV) function in participants with Pulmonary arterial hypertension (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 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •World health organization functional class (WHO FC) II or III. Enrollment will be stratified by WHO FC II or III. Proportion of participants with WHO FC II and WHO FC III are expected to be approximately 40 percent (%) and 60%, respectively
- •Pulmonary arterial hypertension (PAH) etiology belonging to one of the following groups according to 6th world symposium of pulmonary hypertension (WSPH) classification: a) Idiopathic PAH, b) Heritable PAH, c) Drugs or toxins induced d) PAH associated with connective tissue disease, e) PAH associated with congenital heart disease, with simple systemic-to-pulmonary shunt at least 1 year after surgical repair
- •Patients already receiving PAH-specific oral mono or dual therapy (that is, phosphodiesterase type 5 inhibitors [PDE-5i] or soluble guanylate cyclase stimulators [sGCs] and/or endothelin receptor antagonist [ERA]) or patients who are not candidates for these therapies
- •N-terminal-pro-hormone brain natriuretic peptide (NT-proBNP) greater than or equal to (>=) 300 nanograms per liter (ng/L) (greater than or equal to [>=] 300 picograms per milliliter [pg/mL]; >=35.5 picomoles per liter [pmol/L]) at screening
- •Women of childbearing potential must meet the following criteria: a) Have a negative serum pregnancy test during screening and a negative urine pregnancy test on Day 1, b) Agree to use acceptable methods of contraception from Day 1 to at least 30 days after study intervention discontinuation, c) If only using hormonal contraception, have used it for at least 1 month (30 days) before Day 1, and d) Agree to perform monthly pregnancy tests to at least 30 days after study intervention discontinuation
- •6-minute walking distance (6MWD) >=150 meter (m) during screening period
排除标准
- •Prior use of Prostacyclin (IP)-receptor agonist, prostacyclin, or prostacyclin analog. Use of such treatments for vasoreactivity testing is not exclusionary; intermittent use of such treatments for digital ulcers or Raynaud's phenomenon is not exclusionary if stopped > 6 months (180 days) prior to Day 1
- •Treatment with strong inhibitors of CYP2C8 (example, gemfibrozil) within 4 weeks (28 days) prior to Day 1
- •Treatment with another investigational drug planned or taken within 12 weeks (84 days) prior to Day 1
- •Severe coronary heart disease or unstable angina
- •Cerebrovascular events (example, transient ischemic attack, stroke) within 3 months (90 days) prior to Day 1
研究组 & 干预措施
JNJ-67896049
Experimental
Participants will receive JNJ-67896049 tablets at a starting dose of 200 mcg on Day 1. Dose will be up-titrated from Day 1 to the end of Week 12 (Day 84) to determine individual maintenance dose (IMD). Then, participants will receive JNJ-67896049 tablets at their IMD from Week 13 to Week 52.
干预措施: JNJ-67896049 (Drug)
结局指标
主要结局
Change From Baseline to Week 26 in Right Ventricular Stroke Volume (RVSV) Assessed by Pulmonary Artery Flow Magnetic Resonance Imaging (MRI)
时间窗: Baseline, Week 26
Change from baseline to Week 26 in RVSV assessed by pulmonary artery flow MRI was reported.
次要结局
- Change From Baseline to Week 26 in Right Ventricular Ejection Fraction (RVEF) Assessed by MRI(Baseline, Week 26)
- Change From Baseline to Week 26 in Right Ventricular (RV) Mass Index Assessed by MRI(Baseline, Week 26)
- Change From Baseline to Week 26 in Right Ventricular End-Systolic Volume (RVESV) Assessed by MRI(Baseline, Week 26)
- Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 3 Variables(Baseline, Week 26)
- Change From Baseline to Week 26 in Right Ventricular End-Diastolic Volume (RVEDV) Assessed by MRI(Baseline, Week 26)
- Change From Baseline to Week 26 in 6-Minute Walk Distance (6MWD)(Baseline, Week 26)
- Number of Participants With Adverse Events of Special Interest (AESI)(Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days))
- Change From Baseline to Week 26 in Right Ventricular Global Longitudinal Strain (RVGLS) Assessed by MRI(Baseline, Week 26)
- Number of Participants With Change From Baseline to Week 26 in World Health Organization (WHO) Functional Class(Baseline, Week 26)
- Number of Participants With Adverse Events (AEs) Leading to Premature Discontinuation of Study Drug(Day 1 up to last dose of study drug (up to Week 52))
- Number of Participants With Treatment-Emergent Marked Laboratory Abnormalities(Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days))
- Change From Baseline to Week 26 in Number of Non-invasive Low-risk Criteria Among the 8 Variables(Baseline, Week 26)
- Change From Baseline to Week 26 in N-terminal-Pro-Hormone Brain Natriuretic Peptide (NT-proBNP)(Baseline, Week 26)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 up to 3 days after last dose of study drug (up to 52 weeks and 3 days that is 367 days))
研究者
研究点 (35)
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