EUCTR2015-005131-40-DE进行中（未招募）1 期
A PHASE IIb, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLEDSTUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF SILDENAFIL ADDED TO PIRFENIDONE IN PATIENTSWITH ADVANCED IDIOPATHIC PULMONARY FIBROSIS AND RISK OF GROUP 3 PULMONARY HYPERTENSION.
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
- 177
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
- •- Age 40-80 years (inclusive) at Screening
- •- Diagnosis of IPF for at least 3 months prior to screening
- •- Confirmation of IPF diagnosis by the Investigator, in accordance with
- •the 2011 international consensus guidelines, at Screening
- •- Advanced IPF as defined by a measurable carbon monoxide diffusing
- •capacity/pulmonary diffusing capacity [DLCO] <= 40% of predicted
- •value at Screening and risk of Grade 3 PH (as defined in the protocol)
- •- Prior to the start of Screening, receiving pirfenidone for at least 12
- •weeks, and on a dose in the range of 1602 to 2403 mg/day for at least 4
- •weeks prior to the first Screening Visit.
- •- WHO Functional Class II or III at Screening
- •- 6MWD of 100 to 450 meters at Screening
- •- For women of childbearing potential: agreement to remain abstinent
- •or use a non-hormonal contraceptive method with a failure rate of <1%
- •per year during the treatment period and for at least 58 days after the
- •last dose of study treatment
- •- For men who are not surgically sterile: agreement to remain
- •abstinent or use contraceptive measures, and agreement to refrain from
- •donating sperm for at least 118 days after the last dose of study
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 132
排除标准
- •- History of any of the following types of PH: Group 1 pulmonary arterial hypertension (PAH); Group 2 (left-heart disease); Group 3 (due to conditions other than interstitial lung disease; Group 4 (chronic thromboembolic pulmonary hypertension); Group 5 (other disorders)
- •- History of clinically significant cardiac disease in the opinion of the Investigator
- •- History of coexistent and clinically significant (in the opinion of the Investigator) COPD, bronchiectasis, asthma, inadequately treated sleep-disordered breathing, or any clinically significant pulmonary diseases or disorders other than IPF or PH secondary to IPF
- •- Hypotension, autonomic dysfunction, or conditions in which vasodilation may cause an unsafe drop in blood pressure (BP)
- •- History of use of drugs and toxins known to cause PAH
研究者
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