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Prostacyclin Receptor Agonist

Ralinepag for Lung Disease (CAPACITY Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 28
Awards & highlights

CAPACITY Trial Summary

This trial will test if ralinepag (a drug given to treat pulmonary arterial hypertension) can help improve patients' exercise capacity, as measured by how much oxygen they consume during exercise.

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

CAPACITY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 28
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in peak VO2 assessed by CPET
Secondary outcome measures
Change from Baseline in Minute Ventilation (VE)/Carbon Dioxide output (VCO2) slope
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Change from Baseline in health-related quality of life measured by the Short Form Health Survey (SF-36) Scores
+1 more

Side effects data

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

CAPACITY 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 individual maximum tolerated dose (maximum dose of 1400 mcg)
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
107 Previous Clinical Trials
13,377 Total Patients Enrolled

Frequently Asked Questions

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

In how many different facilities is this trial being conducted today?

"There are a dozen medical centres presently enrolling patients for this clinical trial. If you enroll, you will be asked to travel to one of the locations, which include Tampa, Boston, Tucson, and 9 other cities. To cut down on travel, it is best to select a site that is close to your home."

Answered by AI

Is this the first time this type of research has been conducted?

"Presently, 3 ongoing clinical trials for Ralinepag are being conducted in 109 cities and 33 nations. The inaugural study occurred in 2018 and was completed in Phase 3. The sponsor of this trial was United Therapeutics and it included 700 participants. Since 2018, a total of 18,241 similar studies have been conducted."

Answered by AI

What other medical studies have included Ralinepag as a treatment option?

"Ralinepag is currently being studied in 3 clinical trials, with the majority of those trials being Phase 3. The central location for these studies is Leuven, SP, but there are a total of 425 locations running Ralinepag clinical trials."

Answered by AI

What is the current status of Ralinepag's FDA approval process?

"There is both preclinical and clinical data supporting the safety of Ralinepag, so it received a score of 3."

Answered by AI

Who else is applying?

What state do they live in?
Virginia
What portion of applicants met pre-screening criteria?
Did not meet criteria
~2 spots leftby Mar 2025