A Phase 2a Randomized Double-blinded, Placebo And Active Controlled Two Cohort Two Doses Cross-over Multi-center Clinical Study To Assess Efficacy Of A Once Daily Administration Of A Phosphodiesterase 5 Inhibitor (Pf-00489791) For The Treatment Of Vasospasm In Primary And Secondary Raynaud's Phenomenon
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 243
- 试验地点
- 55
- 主要终点
- Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
研究概览
简要总结
The investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active Raynaud's Phenomenon
- •Stable disease and medication requirements over the previous two months
- •For Secondary Raynaud's Phenomenon subjects, a diagnosis of scleroderma using the American College of Rheumatology criteria or by the presence of at least 3/5 features of CREST syndrome
- •both sexes
排除标准
- •Uncontrolled hypertension, diabetes mellitus, angina, or using oral nitrates
- •Smoking within 3 months or smoking cessation using nicotine products
- •Subjects currently taking sildenafil, tadalafil or vardenafil
- •Subjects with ulnar arterial occlusive disease as shown by a modified Allen test
- •Pregnant or breast feeding or considering pregnancy in next 4 months
- •Participation in trial for investigational drug within 30 days
研究组 & 干预措施
Secondary Raynaud 4 mg dose (period 1)
干预措施: PF-00489791 (Drug)
Secondary Raynaud 4 mg dose (period 2)
干预措施: PF-00489791 (Drug)
Secondary Raynaud 20 mg dose (period 1)
干预措施: PF-00489791 (Drug)
Secondary Raynaud 20 mg dose (period 2)
干预措施: PF-00489791 (Drug)
Primary Raynaud 4 mg dose (period 1)
干预措施: PF-00489791 (Drug)
Primary Raynaud 4 mg dose (period 2)
干预措施: PF-00489791 (Drug)
Primary Raynaud 20 mg dose (period 1)
干预措施: PF-00489791 (Drug)
Primary Raynaud 20 mg dose (period 2)
干预措施: PF-00489791 (Drug)
结局指标
主要结局
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
时间窗: Baseline, Week 4
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.
次要结局
- Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4(Baseline, Week 4)
- Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4(Baseline, Week 1, Week 2, Week 3, Week 4)
- Plasma Concentration of PF-00489791 and Its Metabolites(Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period))
- Number of Participants With Abnormal Electrocardiogram (ECG) Values(Screening up to 28 days after last study dose (up to 98 days))
- Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4(Baseline, Week 1, 2, 3, 4)
- Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort(Baseline, Day 14, 28)
- Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements(Screening up to 28 days after last study dose (up to 98 days))
- Number of Participants With Laboratory Test Abnormalities(Screening up to 28 days after last study dose (up to 98 days))