A 16-Week, International, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of Oral UT-15C Sustained Release Tablets in Subjects With Pulmonary Arterial Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 62
- 主要终点
- 6-minute Walk Distance (6MWD)
研究概览
简要总结
This study is an international, multi-center, randomized, double-blind, placebo-controlled study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e., endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk test. Study procedures include routine blood tests, medical history, physical exams, disease evaluation, and exercise tests.
Patients who complete all assessments for 16-weeks will also be eligible to enter an open-label, extension phase study (FREEDOM - EXT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject is eligible for inclusion in this study if all of the following criteria apply:
- •Between 18 and 75 years of age, inclusive.
- •Body weight at least 40 kg (approximately 90 lbs.)
- •PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin use; associated with collagen vascular disease; associated with repaired congenital shunts; associated with HIV.
- •Currently receiving an approved endothelin receptor antagonist and/or an approved phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least the last 30 days.
- •Baseline six-minute walk distance (6MWD) between 150-425 meters
- •Previous testing (e.g., right heart catheterization, echocardiography) consistent with the diagnosis of PAH.
- •Reliable and cooperative with protocol requirements.
排除标准
- 未提供
研究组 & 干预措施
Placebo
Identical placebo tablets to UT-15C, doses were titrated in the same manner
干预措施: Placebo (Drug)
UT-15C SR
Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
干预措施: UT-15C SR (Drug)
结局指标
主要结局
6-minute Walk Distance (6MWD)
时间窗: Baseline and 16 weeks
Placebo-corrected change in 6MWD from Baseline to Week 16, correlates with the current clinical standard for assessing patient functional status in the treatment of PAH and is considered an objective measure of patient functional status by the American Thoracic Society (ATS). The 6MWD was to be assessed between 3 and 6 hours after the morning dose of study drug and background therapy(ies).
次要结局
- Clinical Worsening Assessment(Baseline and 16 Weeks)
- Borg Dyspnea Score(Baseline and 16 Weeks)
- World Health Organization (WHO) Functional Class(Baseline and 16 Weeks)
- Symptoms of PAH(Baseline and 16 Weeks)
- Dyspnea Fatigue Index(Baseline and 16 Weeks)
- N-terminal proBNP (NT-proBNP)(Baseline and 16 Weeks)
- Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)(Baseline and 16 Weeks)