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Prostacyclin Analogue
EXPEDITE: A Study of Remodulin Induction Followed by Orenitram Optimization to Treat Pulmonary Arterial Hypertension
Fresno, CA
Phase 4
Waitlist Available
Led By Chad E Miller, MD
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 at week 16
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
Summary
This trial will help determine the best dose of Orenitram for people with PAH who are switching from Remodulin injection.
See full description
Eligible Conditions
- Pulmonary Arterial Hypertension
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of Subjects Achieving Oral Treprostinil Dose
Secondary study objectives
Achievement of Low Risk Category in Clinical Parameters
Change in 6-minute Walk Distance (6MWD)
Change in Borg Dyspnea Score
+22 moreSide effects data
From 2022 Phase 4 trial • 36 Patients • NCT0349768986%
Headache
71%
Nausea
60%
Diarrhoea
57%
Flushing
51%
Pain in jaw
43%
Pain in extremity
43%
Vomiting
40%
Fatigue
26%
Infusion site pain
26%
Pain
20%
Dizziness
17%
Oedema peripheral
17%
Muscle spasms
17%
Dyspnoea
14%
Infusion site irritation
14%
Back pain
11%
Abdominal pain
11%
Dyspepsia
11%
Arthralgia
11%
Decreased appetite
9%
Cough
9%
Oropharyngeal pain
9%
Pneumonia
9%
Hypokalaemia
9%
Anxiety
9%
Device dislocation
6%
Nasal congestion
6%
Bronchitis
6%
Infusion site infection
6%
Urinary tract infection
6%
Chills
6%
Non-cardiac chest pain
6%
Infusion site swelling
6%
Flatulence
6%
Syncope
6%
Tremor
6%
Musculoskeletal stiffness
6%
Hot flush
6%
Ligament sprain
6%
Insomnia
6%
Rash
3%
Upper gastrointestinal haemorrhage
3%
Acute respiratory failure
3%
Pulmonary arterial hypertension
3%
Respiratory failure
3%
Febrile neutropenia
3%
Right ventricular failure
3%
Bacterial sepsis
3%
Endocarditis
3%
Septic embolus
3%
Suicidal ideation
3%
Hypotension
100%
80%
60%
40%
20%
0%
Study treatment Arm
Intravenous/Subcutaneous Treprostinil; Oral Treprostinil
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intravenous/Subcutaneous Treprostinil; Oral TreprostinilExperimental Treatment1 Intervention
Subjects began Remodulin at 2 ng/kg/min subcutaneously (SC) or intravenously (IV) and were optimized to their maximum tolerated dose (MTD) of Remodulin. Subjects were then transitioned to Orenitram XR tablets (oral) based upon their Remodulin dose. Subjects were optimized on Orenitram therapy to a MTD. There were no maximum Remodulin or Orenitram doses specified during the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intravenous/Subcutaneous Treprostinil; Oral Treprostinil
2019
Completed Phase 4
~40
Find a Location
Closest Location:The Ohio State University Wexner Medical Center· Columbus, OH· 4 miles
Who is running the clinical trial?
United TherapeuticsLead Sponsor
110 Previous Clinical Trials
14,444 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
8,203 Patients Enrolled for Pulmonary Arterial Hypertension
Chad E Miller, MDPrincipal InvestigatorPiedmont Healthcare Pulmonary and Critical Care Research