ACTRN12621000459820招募中2 期
A Randomized, Placebo-controlled Phase 2a Study to Assess the Safety and Efficacy of Cilnidipine (10 mg and 20 mg) Alone and in Combination with 5 mg Tadalafil, in Participants with Diagnosis of Secondary Raynaud’s Disease,
AISA Pharma Australia Pty. Ltd.0 个研究点目标入组 76 人开始时间: 2021年4月20日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 76
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants at least 18 years of age diagnosed with severe secondary Raynaud’s disease (Raynaud’s Condition Score [RCS] greater than or equal to 40 and at least a 2-phase color change in fingers of pallor, cyanosis, and/or reactive hypermedia in response to cold exposure or emotion) mostly resulting from SSc and exhibiting regular and frequent RP attacks (averaging at least one attack per day) during the Screening period.
排除标准
- •1.A participant who meets any of the following exclusion criteria must be excluded from the study:
- •1. Primary Raynaud’s disease.
- •2. History of Raynaud’s attacks of sufficient severity as to require in-patient hospitalization (within the last 6 months).
- •3. The SBP of < 95 mm Hg during Randomization visit (Day 0).
- •4. Pulmonary hypertension requiring specific therapy for this condition.
- •5. Participants with an allergy to dihydropyridine CCBs that results in clinical findings such as profound hypotension, hives, rash, urticaria, wheezing and changes in breathing (Common treatment limiting adverse events [AEs] that occur with CCBs nifedipine and amlodipine such as edema, headache, heart rate changes, tachycardia, fatigue, constipation, flushing, drowsiness, dizziness should not limit enrollment into this study).
- •6. History of other chronic pain condition that could confound recording of pain scores during the study period.
- •7. Any prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that in the opinion of the Investigator(s), would contraindicate administration of the study medication, or interfere with the study evaluations, or interfere with the participants ability to comply with the study protocol.
- •8. Cognitive or language difficulties that would impair completion of the study assessments.
- •9. Use of any investigational product (IP) or investigational medical device or participation in investigational drug studies within 30 days prior to enrollment in the study.
- •10. Those receiving nitrates, alpha blockers, PDE inhibitors (outside of stable administration for PAH), prostacyclins or endothelin antagonists.
- •11. History of orthostatic hypertension, dizziness or fainting spells, acute coronary or cerebrovascular event within 3 months of study enrollment.
- •12. History of major thoracic, abdominal, or vascular surgery within 6 months of study enrollment; History of sympathectomy.
- •13. Severe cardiomyopathy, severe valvular heart disease, chronic kidney disease (CKD) stage 3 or greater, evidence of malignancy, end stage lung disease.
- •14. Pregnant or lactating women.
- •15. Women of childbearing potential (WOCBP) unable to comply with contraceptive requirements during the study period.
- •16. Males with partners who are WOCBP and are unable to comply with the contraceptive requirements during the study.
- •17. History of drug or excess alcohol use that in the opinion of the Investigator(s) would affect the participant’s ability to reliably participate in the study. NHMRC guidelines for regular alcohol consumption in healthy adults are no more than 10 standard drinks per week and no more than four standard drinks on any one day.
- •18. Use of tobacco products of any type in the preceding one month and for the duration of the study.
研究者
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