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Prostacyclin Receptor Agonist

Ralinepag for Pulmonary Arterial Hypertension (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

Summary

This trial is testing a medication called ralinepag to see if it can help people with Pulmonary Arterial Hypertension (PAH) exercise better. The medication works by improving blood flow in the lungs, making it easier for the heart to pump blood. The study will measure changes in exercise ability after several months of treatment.

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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in peak VO2 assessed by CPET
Secondary study objectives
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%
Myalgia
27%
Flushing
18%
Anaemia
18%
Dizziness
16%
Fatigue
16%
Arthralgia
16%
Pain in extremity
13%
N-terminal prohormone brain natriuretic peptide increased
13%
Right ventricular failure
13%
Hypotension
11%
Upper respiratory tract infection
11%
Palpitations
11%
Vomiting
11%
Iron deficiency
11%
Muscle spasms
9%
Urinary tract infection
9%
Cardiac failure
9%
Oedema peripheral
9%
Pneumonia
9%
Lower respiratory tract infection
9%
Dyspnoea exertional
9%
Dyspnoea
9%
Pruritus
7%
Hypokalaemia
7%
Respiratory tract infection
7%
Abdominal pain
7%
Non-cardiac chest pain
7%
Influenza
7%
Bronchitis
7%
Hyperkalaemia
7%
Back pain
7%
Syncope
7%
Presyncope
7%
Anxiety
7%
Pulmonary arterial hypertension
4%
Haematemesis
4%
Cardiac arrest
2%
Deep vein thrombosis
2%
Abdominal distension
2%
COVID-19
2%
Brain abscess
2%
Varices oesophageal
2%
Atrial fibrillation
2%
Benign breast neoplasm
2%
COVID-19 pneumonia
2%
Pleural effusion
2%
Atrial flutter
2%
Breast cancer in situ
2%
Pulmonary infarction
2%
Oesophageal varices haemorrhage
2%
Pneumonia aspiration
2%
Acute kidney injury
2%
Acute respiratory failure
2%
Arrhythmia supraventricular
2%
Asthenia
2%
Cardiac failure congestive
2%
Cardiopulmonary failure
2%
Chest pain
2%
Clostridium difficile infection
2%
Device related sepsis
2%
Drug withdrawal syndrome
2%
Epilepsy
2%
Foot fracture
2%
Gastroenteritis viral
2%
Haemoptysis
2%
Head injury
2%
Hyponatraemia
2%
Multiple organ dysfunction syndrome
2%
Myositis
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 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
110 Previous Clinical Trials
14,516 Total Patients Enrolled
59 Trials studying Pulmonary Arterial Hypertension
8,275 Patients Enrolled for Pulmonary Arterial Hypertension
~2 spots leftby Sep 2025
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