Comparison of Phosphodiesterase-5 Inhibitor and Calcium Channel Inhibitor for the Treatment of Secondary Raynaud Phenomenon, Double Blind, Randomized, Cross-over Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- RP Attacks Per Day
研究概览
简要总结
The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.
Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •secondary Raynaud's phenomenon
排除标准
- •primary raynaud phenomenon
- •active infection
- •hypersensitivity to PDE5 inhibitor or Calcium Chanel Blocker (CCB)
- •elevated AST/ALT (3 times above the upper normal limit)
- •severe renal failure
- •patients on nitrite or nitric oxide (NO) donor treatment
- •recent history of cerebrovascular accidents, acute myocardial infarction, or coronary artery bypass surgery
- •hypotension (less than 90/50 mmHg) or uncontrolled hypertension
研究组 & 干预措施
Amlodipine-Udenafil (AU) arm
Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks
干预措施: Udenafil or Amlodipine (Drug)
Udenafil-Amlodipine (UA) arm
Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks
干预措施: Udenafil or Amlodipine (Drug)
结局指标
主要结局
RP Attacks Per Day
时间窗: baselin and 4 weeks
Change in RP frequency after amlodipine and udenafil number of RP attack per day 0 -- unlimited.
次要结局
- Change in Peak Systolic Flow (cm/Sec)(baseline and 4 weeks)
- Change in Raynaud's Condition Score (RCS)(baseline and 4 weeks)
- Change in the RP Duration(baseline and 4 weeks)
- Change in Health Assessment Questionnaire (HAQ)(0 and 4 weeks)
- Change in Physician's Global Assessment on Visual Analogue Scale (VAS)(at 0 (baseline) and 4 weeks (after treatment))
- Change in Digital Ulcer Number(baseline and 4 weeks)
- Time-averaged Peak Velocity (cm/Sec)(baseline and 4 weeks)
- Dorsal-digital-difference.(baseline and 4 weeks)
研究者
Eun Bong Lee
Direct, Division of Rheumatology
Seoul National University Hospital