Single Dose, Double-blind, Placebo-controlled, Single Center, Randomized Cross-over Study to Investigate Safety, Tolerability, Pharmacodynamics and Pharmacokinetic Properties of BAY63-2521 After Oral Dosing in 20 Patients With Raynaud's Phenomenon (RP)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 23
- 主要终点
- Pulse rate
研究概览
简要总结
Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold causing acute lowering of blood flow through the digits. In this trial the safety and efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood flow will be measured during a cold exposure test in patients suffering from Raynaud's phenomenon. Measurements of two periods will be compared: in one period the patient will be given active drug and in the other period a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from Raynaud's phenomenon diagnosed at least ≥1 year before beginning of the study of the following origin:
- •idiopathic (primary)
- •limited cutaneous Scleroderma associated
- •diffuse cutaneous Scleroderma associated
- •mixed connective tissue disease associated
排除标准
- •Patients taking medication interfering with the digital flow measurement such as calcium channel blockers (CCB), phosphodiesterase 5 (PDE5) inhibitors, endothelin receptor antagonists (ERA), Nitrates
- •Systolic blood pressure (SBP) below 105mmHg at rest
研究组 & 干预措施
Riociguat+Placebo
Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
Riociguat+Placebo
Randomization order 1: first single oral dose of 2 mg BAY63-2521, then matching placebo
干预措施: Placebo (Drug)
Placebo+Riociguat
Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521
干预措施: Riociguat (Adempas, BAY63-2521) (Drug)
Placebo+Riociguat
Randomization order 2: first matching placebo, then single oral dose of 2 mg BAY63-2521
干预措施: Placebo (Drug)
结局指标
主要结局
Pulse rate
时间窗: 5 weeks
Blood pressure
时间窗: 5 weeks
Number of participants with adverse events as a measure of safety and tolerability
时间窗: 5 weeks
Incidence of participants showing changes during clinical laboratory and hematology assessment
时间窗: From baseline to 5 weeks
Plasma concentration at 2 h after riociguat administration
时间窗: After 2 hours
Placebo corrected change in digital blood flow at room temperature, measured by Laser Doppler Perfusion Imaging
时间窗: At baseline and after 2h
Placebo corrected change in digital blood flow during cold exposure, measured by Laser Doppler Perfusion Imaging
时间窗: At baseline and after 2h
次要结局
未报告次要终点