Phase 4 Peripheral Arterial Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 or older
- People with active Raynaud's Phenomenon that has not responded well to treatment, with four or more Raynaud's attacks per week in the four weeks before joining the study
- People with either primary Raynaud's Phenomenon, or Raynaud's Phenomenon caused by a connective tissue disease such as scleroderma, limited scleroderma (CREST), mixed connective tissue disease, Sjögren's syndrome, or lupus — where the underlying condition has been diagnosed using standard medical criteria
- People already taking certain medications for Raynaud's (such as sildenafil, tadalafil, vardenafil, calcium channel blockers, or similar medicines), provided the dose has been stable with no changes for at least three months
- Women who could become pregnant, provided a recent blood pregnancy test has come back negative and an agreement to follow the trial's contraceptive requirements is in place
- Women who cannot become pregnant, either because they have been through menopause (no periods for 12 months, confirmed with a hormone blood test), or because they have had a documented hysterectomy, removal of both ovaries, or removal of the fallopian tubes
Who may not be able to join:
- People with uncontrolled high blood pressure, uncontrolled diabetes, a heart attack or stroke within the past three months, or a history of a surgical procedure called a sympathectomy
- People who have smoked within the past three months, or who are currently using nicotine products to quit smoking
- People with a history of alcohol or other substance misuse within the past year
- People who have been found to have a bowel condition called diverticulosis, confirmed by a camera examination of the lower bowel showing at least three pouches (diverticula)
- People with moderate to severe liver disease (classified as Child-Pugh Class B or C)
- People currently taking another type of medicine in the prostacyclin class (confirm with trial site)
- People who are pregnant, breastfeeding, or planning to become pregnant in the next four months
- People who have taken part in another clinical trial involving an experimental drug or therapy within the past 30 days, or within five half-lives of an experimental biologic medicine — whichever period is longer
- People with a serious ongoing or unstable medical, surgical, psychiatric, or other health condition that, in the investigator's judgement, could affect safety, the ability to provide informed consent, or the ability to follow study procedures
- People who have been hospitalised for any reason in the seven days before the screening period begins
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Aaron B Waxman, MD, PhD, Brigham and Women's Hospital, Pulmonary Vascular Disease Program
Phone: 6175259733
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change in the Raynaud's Condition Score from baseline (6-week run in), comparing treprostinil treatment phase vs. baseline phase.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.