EUCTR2014-000865-34-GB进行中（未招募）不适用
A multi-center, double-blind, randomized, placebo-controlled, parallel group, exploratory Phase 2 study to assess efficacy and safety of selexipag in adult subjects with Raynaud's Phenomenon secondary to Systemic Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
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
- •At Screening visit:
- •Signed informed consent prior to any study-mandated procedure.
- •Male and female subjects aged 18 years and above with history of
- •recurrent multiple weekly RP attacks secondary to SSc.
- •A woman of childbearing potential is eligible only if the following
- •-Negative urine pregnancy test at screening visit.
- •-Agreement to undertake monthly pregnancy tests during the
- •study and up to 30 days after study treatment discontinuation.
- •-Agreement to use one reliable method of birth control
- •At randomization visit all the above apply and:
- •Subjects with RP who have experienced at least 7 RP attacks in the 7 days prior to the randomization visit (i.e., baseline week) with attacks on at least 5 different days.
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •At screening visit:
- •Known severe hepatic impairment (i.e. Child-Pugh C).
- •Known hypersensitivity to selexipag or drugs of the same class, or
- •any of their excipients.
- •Subjects who have received prostacyclin (epoprostenol) or
- •prostacyclin analogs (i.e., treprostenol, iloprost, beraprost) within 3
- •months prior to the screening visit or are scheduled to receive any of
- •those treatments during the intended study period.
- •Subjects who have received a Phosphodiesterase type 5 (PDE-5)
- •inhibitor within 1 week prior to the screening visit or are scheduled
- •to receive any such treatment during the intended study period.
- •Any dose change or initiation of any of the following drugs within 1
- •month prior to the screening visit:
- •oCalcium channel blockers
- •oNitrates or nitric oxide donors
- •oAlpha-blockers
- •oAntithrombotic agents
- •oNSAIDs (occasional use allowed)
- •oAngiotensin Converting Enzyme (ACE) inhibitors
- •oBeta-blockers
- •oSystemic corticosteroids
- •oFluoxetine
- •At randomization visit all the above apply and:
- •Severe renal insufficiency: estimated creatinine clearance <30
- •mL/min/1.73 m² or serum creatinine >2.5 mg/dL (221 µmol/L)
- •based on central laboratory results from screening visit blood sample
- •Subjects who were not compliant with run-in procedures
研究者
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