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Prostacyclin Analogue
ADAPT - A Patient Registry of the Real-world Use of Orenitram® (ADAPT Trial)
Roanoke, VA
N/A
Waitlist Available
Research Sponsored by United Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 78
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation
See full description
Eligible Conditions
- Pulmonary Arterial Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 78
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 78
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
To assess treatment-related outcomes during routine clinical care.
Side effects data
From 2020 Phase 2 trial • 12 Patients • NCT0266389567%
Headache
50%
Abdominal Pain
42%
Diarrhea
25%
Nausea
17%
Jaw Pain
17%
dizziness
17%
Flushing
8%
epistaxis
8%
hypotension
8%
weight loss
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Treprostinil
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oral treprostinilExperimental Treatment1 Intervention
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treprostinil
FDA approved
Find a Location
Closest Location:Lima Memorial Hospital· Lima, OH· 76 miles
Who is running the clinical trial?
United TherapeuticsLead Sponsor
110 Previous Clinical Trials
14,180 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
7,939 Patients Enrolled for Pulmonary Arterial Hypertension