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Prostacyclin Receptor Agonist

Ralinepag for Pulmonary Arterial Hypertension

Phase 3
Recruiting
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 the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years
Awards & highlights

Study Summary

This trial is designed to see if adding ralinepag to standard PAH care or PAH-specific background therapy can improve outcomes for people with WHO Group 1 PAH.

Eligible Conditions
  • High Blood Pressure
  • Connective Tissue Disease
  • Lung Disease
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Vascular Disease
  • Cardiovascular Disease
  • Respiratory Diseases

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and the study duration was event-based. this parameter was assessed from randomization until the conclusion of the study, up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time from randomization to the first adjudicated protocol-defined clinical worsening event
Secondary outcome measures
Change from Baseline in 6-minute walk distance (6MWD)
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
+8 more

Side effects data

From 2021 Phase 2 trial • 45 Patients • NCT02279745
64%
Headache
38%
Diarrhoea
33%
Pain in jaw
31%
Nausea
27%
Myalgia
27%
Flushing
18%
Dizziness
18%
Anaemia
16%
Fatigue
16%
Pain in extremity
16%
Arthralgia
13%
Right ventricular failure
13%
N-terminal prohormone brain natriuretic peptide increased
13%
Hypotension
11%
Iron deficiency
11%
Muscle spasms
11%
Palpitations
11%
Vomiting
11%
Upper respiratory tract infection
9%
Dyspnoea
9%
Pneumonia
9%
Oedema peripheral
9%
Cardiac failure
9%
Dyspnoea exertional
9%
Lower respiratory tract infection
9%
Urinary tract infection
9%
Pruritus
7%
Pulmonary arterial hypertension
7%
Bronchitis
7%
Abdominal pain
7%
Syncope
7%
Non-cardiac chest pain
7%
Anxiety
7%
Influenza
7%
Hyperkalaemia
7%
Presyncope
7%
Back pain
7%
Hypokalaemia
7%
Respiratory tract infection
4%
Cardiac arrest
4%
Haematemesis
2%
Head injury
2%
Drug withdrawal syndrome
2%
Foot fracture
2%
Myositis
2%
Acute respiratory failure
2%
Oesophageal varices haemorrhage
2%
Haemoptysis
2%
Clostridium difficile infection
2%
Pneumonia aspiration
2%
Breast cancer in situ
2%
Gastroenteritis viral
2%
Arrhythmia supraventricular
2%
Brain abscess
2%
Cardiopulmonary failure
2%
Chest pain
2%
Atrial fibrillation
2%
Epilepsy
2%
Acute kidney injury
2%
Asthenia
2%
Device related sepsis
2%
Abdominal distension
2%
COVID-19
2%
Cardiac failure congestive
2%
Pleural effusion
2%
Pulmonary infarction
2%
Varices oesophageal
2%
Atrial flutter
2%
Deep vein thrombosis
2%
Hyponatraemia
2%
Benign breast neoplasm
2%
COVID-19 pneumonia
2%
Multiple organ dysfunction syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oral Ralinepag

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: RalinepagExperimental Treatment1 Intervention
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo tablets (oral)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ralinepag
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

United TherapeuticsLead Sponsor
108 Previous Clinical Trials
13,387 Total Patients Enrolled

Media Library

Ralinepag (Prostacyclin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03626688 — Phase 3
High Blood Pressure Research Study Groups: Placebo, Ralinepag
High Blood Pressure Clinical Trial 2023: Ralinepag Highlights & Side Effects. Trial Name: NCT03626688 — Phase 3
Ralinepag (Prostacyclin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03626688 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some other studies that have been done using Ralinepag?

"3 trials for Ralinepag are ongoing, with the majority being Phase 3 studies. The town of Leuven in Belgium has the most clinical studies for this treatment, but 425 locations worldwide are running trials."

Answered by AI

Are recruitment efforts for this trial focused on individuals above the age of 20?

"This study is looking for individuals who are over the age of 18 and under the age of 75."

Answered by AI

Has Ralinepag undergone the FDA's regulatory process?

"There is data from previous phases of clinical trials and multiple rounds of safety testing that suggest Ralinepag is a safe medication, so it received a score of 3."

Answered by AI

Might I be a compatible candidate for this research?

"The study's aim is to treat respiratory tract diseases in patients between the ages of 18 and 75. A total of 700 individuals are needed for the trial."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
Other
Florida
Texas
How old are they?
18 - 65
What site did they apply to?
Keck Hospital of USC
University of California Davis Medical Center
Memorial Hermann Hospital
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
1
3+

Why did patients apply to this trial?

I have lost many job offers due to my Extremely High Blood Pressure. It's always 180+/something else high.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
2018. "A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03626688.
~150 spots leftby May 2025
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