NCT05612035进行中（未招募）2 期
A Phase 2a Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-5475 in Adults With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 129
- 试验地点
- 168
- 主要终点
- Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
研究概览
简要总结
Researchers are looking for ways to treat pulmonary hypertension (PH) caused by chronic obstructive pulmonary disease (COPD). The goal of the study is to learn if people who take frespaciguat can walk farther in 6 minutes at Week 24 compared to people who take placebo.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The key inclusion and
排除标准
- •include but are not limited to the following:
- •Inclusion Criteria:
- •Has Group 3.1 pulmonary hypertension chronic obstructive pulmonary disease (PH-COPD) as defined by the Clinical Classification of Pulmonary Hypertension.
- •Has a right heart catheterization (RHC) at screening or historical RHC within 12 months before screening that meets hemodynamic criteria.
- •Has a physician diagnosis of obstructive lung disease on pulmonary function testing (PFT) performed at screening.
- •Has a WHO Functional Class assessment of Class II to IV.
- •If on supplemental oxygen, the regimen must be stable.
- •Has stable and optimized chronic, baseline COPD-specific therapy.
- •If on PDE5 inhibitor, has stable concomitant use (initiated at least 3 months prior to randomization and no change in drug or dosage for at least 3 months prior to randomization) and changes to PDE5 inhibitor dosing is not anticipated during the 24 week Base Period.
- •If on antihypertensives and/or a diuretic regimen has stable concomitant use.
- •If on anticoagulants has stable concomitant use.
- •Is of any sex/gender from 40 to 85 years of age inclusive.
- •Female is not pregnant or breastfeeding, and is not of childbearing potential or uses acceptable contraceptive method or abstains from sexual intercourse, or has a negative highly sensitive pregnancy test within 24 hours before the first dose of study intervention, or whose history and sexual activity has been reviewed by the investigator.
- •Exclusion criteria:
- •Has Group 1 pulmonary arterial hypertension (PAH), Groups 2, 4 or 5 pulmonary hypertension (PH).
- •Has non-COPD related Group 3 PH.
- •Has evidence of untreated more than mild obstructive sleep apnea.
- •Has significant left heart disease.
- •Expects to receive a lung and/or heart transplant from screening through the end of the 24 week Base Period.
- •Has evidence of a resting oxygen saturation (SpO2) < 88%.
- •Has experienced a moderate or severe COPD exacerbation within 2 months before randomization.
- •Has experienced right heart failure within 2 months before randomization.
- •Has uncontrolled tachyarrhythmia.
- •Has acute coronary syndrome, undergone coronary artery bypass graft, or percutaneous coronary intervention within 2 months before randomization.
- •Has evidence of significant chronic renal insufficiency.
- •Has evidence of chronic liver disease, portal hypertension, cirrhosis, or hepatic abnormalities.
- •Initiated a pulmonary rehabilitation program within 2 months before randomization.
- •Has impairments that limit the ability to perform 6MWT.
- •Has history of cancer.
- •Is a user of illicit drugs or has a recent history of drug/alcohol abuse or dependence.
- •Has used PAH-specific therapies within 2 months of randomization.
研究组 & 干预措施
Frespaciguat
Experimental
Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period).
干预措施: Frespaciguat (Drug)
Placebo
Placebo Comparator
Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).
干预措施: Frespaciguat (Drug)
Placebo
Placebo Comparator
Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
时间窗: Baseline and Week 24
6MWD is assessed using the 6-minute walk test (6MWT).
次要结局
- Mean Change From Baseline in 6MWD at Week 12(Baseline and Week 12)
- Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12(Baseline and Week 12)
- Mean Change From Baseline in NT-ProBNP at Week 24(Baseline and Week 24)
- Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12(Baseline and Week 12)
- Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24(Baseline and Week 24)
- Percentage of Participants With One or More Adverse Events (AEs)(Up to Week 206)
- Percentage of Participants who Discontinued Study Treatment due to an AE(Up to Week 204)
研究者
研究点 (168)
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