NCT02050360已完成2 期
Efficacy and Safety of "as Required" Sildenafil for Patients With Moderate to Severe Raynaud's Phenomenon (RP)
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.
研究概览
简要总结
The purpose of this study is to determine whether "on-demand" sildenafil is effective in the treatment of Raynaud's phenomenon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Raynaud's Phenomenon characterized by a clinical history of primary or secondary Raynaud's Phenomenon
- •At least 7 RP attacks per week on 5 or more days per week (assessed over the 2 weeks preceding inclusion)
- •Patients who have dated and signed the informed consent form
- •Contraception for women
排除标准
- •Recently diagnosed RP (less than 2 months).
- •Uncontrolled hypertension, diabetes mellitus, angina
- •Haemodynamic instability
- •Nonarteritic ischemic optic neuropathy
- •Pulmonary hypertension
- •Subjects currently taking sildenafil, tadalafil or vardenafil
- •Subjects currently taking nitrates
- •Subjects currently taking strong CYP3A inhibitors
- •Pregnancy (or considering pregnancy in the next 4 months)
- •Breast feeding
- •Participation in another clinical trial
研究组 & 干预措施
Sildenafil 40 mg
Experimental
Sildenafil 40 mg
干预措施: Sildenafil 40 mg (Drug)
Sildenafil 80 mg
Experimental
Sildenafil 80 mg
干预措施: Sildenafil 80 mg (Drug)
Placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Mean change in the Raynaud's Condition Score (RCS) during treatment, as compared to placebo.
时间窗: 7 days
RCS is self-reported every day and averaged over 7-day periods
次要结局
- Frequency of RP: number of RP attacks during treatment, as compared to placebo.(7 days)
- Patients' preference: comparison between the number of patients favoring a treatment to another.(Every 3 weeks of treatment (week 3, 6 and 9))
- Microvascular reactivity: index of skin perfusion in response to local/regional cooling after a single dose of sildenafil, as compared to placebo (laboratory experiments)(Week 1, 2 and 3)
- Frequency and severity of adverse drug events during treatment, as compared to placebo(7 days)
- Pain associated with RP: Mean change in the Raynaud's pain score during treatment, as compared to placebo.(7 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Evaluate The Clinical Effectiveness, Safety And Tolerability Of Sildenafil Used In Doses ≥20mg TID For The Treatment Of Pulmonary Arterial HypertensionPulmonary Arterial HypertensionNCT01365585Pfizer's Upjohn has merged with Mylan to form Viatris Inc.227
已完成
不适用
Efficacy and safety of sildenafil in the treatment of pulmonary arterial hypertension (PAH) after cardiac surgery in Japanese pediatric population - a PAH managementpulmonary hypertensionJPRN-UMIN000012669Osaka Medical College20
终止
2 期
Effect of Sildenafil for Sustained PAH After MV Surgery (SUPERIOR Trial)Hypertension, PulmonaryDiseases of Mitral ValveNCT02435303Asan Medical Center2
Unknown
3 期
Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary HypertensionPulmonary HypertensionNCT01091012Hospital Universitari Vall d'Hebron Research Institute30
已完成
4 期
Randomized, Controlled Trial of Regular Sildenafil Citrate in the Prevention of Altitude IllnessAcute Mountain SicknessHigh Altitude Pulmonary EdemaNCT00627965Altitude Physiology Expeditions62