ACTRN12621000459820
Recruiting
Phase 2
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 sites76 target enrollmentApril 20, 2021
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Raynaud's syndrome
- Sponsor
- AISA Pharma Australia Pty. Ltd.
- Enrollment
- 76
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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