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Prostacyclin Receptor Agonist

Ralinepag for Pulmonary Arterial Hypertension

Phase 3
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
Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 years
Awards & highlights

Study Summary

This trial is for participants with pulmonary arterial hypertension who have participated in another study of ralinepag. It is an extension study, which means participants will continue to receive the study drug.

Who is the study for?
This trial is for individuals with WHO Group 1 Pulmonary Arterial Hypertension (PAH) who completed a prior ralinepag study. Participants must agree to use contraception if conception is possible and not attempt pregnancy during the study. Those who had drug-related issues or didn't complete previous ralinepag studies, are pregnant or breastfeeding, or had certain medical procedures are excluded.Check my eligibility
What is being tested?
The trial tests the long-term effects of Ralinepag on PAH in an open-label extension format. This means everyone gets Ralinepag and knows what they're taking. It's for those who've already been part of earlier Phase 2 or Phase 3 trials involving this medication.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones associated with PAH medications like Ralinepag may include headaches, diarrhea, nausea, rash, jaw pain, and flushing. Side effects can vary based on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I agree to use birth control during the study and for 30 days after.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 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
Number of subjects with treatment-emergent adverse events [Safety and Tolerability]

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

1Treatment groups
Experimental Treatment
Group I: RalinepagExperimental Treatment1 Intervention
Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
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
58 Trials studying Pulmonary Arterial Hypertension
7,229 Patients Enrolled for Pulmonary Arterial Hypertension

Media Library

Ralinepag (Prostacyclin Receptor Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT03683186 — Phase 3
Pulmonary Arterial Hypertension Research Study Groups: Ralinepag
Pulmonary Arterial Hypertension Clinical Trial 2023: Ralinepag Highlights & Side Effects. Trial Name: NCT03683186 — Phase 3
Ralinepag (Prostacyclin Receptor Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03683186 — Phase 3

Frequently Asked Questions

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

Are elderly citizens being sought after for this research?

"To be applicable for this trial, individuals must be under 75 years old and have already celebrated their 18th birthday."

Answered by AI

Has a similar study been conducted before?

"There have been 3 trials for Ralinepag since 2018, with the most recent one completed earlier this year. The initial trial was sponsored by United Therapeutics and had 700 participants. It reached Phase 3 approval in 2018. Since then, 2 more trials have taken place across 109 cities and 33 countries"

Answered by AI

Has Ralinepag received official sanctioning from the FDA?

"There is some efficacy data and multiple rounds of safety data available from Phase 3 trials, which leads our team to believe that Ralinepag rates a 3 on the Power Safety Scale."

Answered by AI

Are new participants still being accepted into this clinical trial?

"Unfortunately, this particular trial is not currently looking for more patients. Although, it is worth noting that the study was last updated on September 30th, 2022 and originally posted on September 23rd, 2019. Additionally, there are 1621 respiratory tract disease trials and 3 Ralinepag studies actively recruiting patients."

Answered by AI

How many people have been chosen to participate in this experiment?

"No, this study is no longer recruiting patients. The listing for this clinical trial was first posted on September 23rd, 2019 and updated for the last time on September 30th, 2020. However, there are presently 1621 other trials seeking participants with respiratory tract diseases and 3 studies investigating Ralinepag that are actively admitting patients."

Answered by AI

How can I become a participant of this research project?

"This study is looking for 1000 adult patients that have respiratory tract diseases. The age limit for participants is 75 years old."

Answered by AI

What is the extent of testing that has been done on Ralinepag?

"Ralinepag was first researched in 2018 at Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80. Since then, there have been 2 more completed studies and 3 ongoing ones-- a large number of which are based in Weston, Florida."

Answered by AI

How many research facilities are handling this project?

"So far, 68 people have signed up for this trial at locations such as Cleveland Clinic Florida in Weston, University of Chicago Medical Center in Chicago, and University of Miami in Miami. There are also 68 other locations recruiting patients for the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What site did they apply to?
Mount Sinai School of Medicine
Recent research and studies
clinicaltrials.govStudy
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
2019. "A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03683186.
All > Pulmonary Arterial Hypertension > Pulmonary Hypertension
~51 spots leftby Sep 2024
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