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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to week 28
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 28
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 moreSide effects data
From 2021 Phase 2 trial • 45 Patients • NCT0227974564%
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%
Abdominal pain
7%
Syncope
7%
Non-cardiac chest pain
7%
Bronchitis
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
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
108 Previous Clinical Trials
14,383 Total Patients Enrolled
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