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Prostacyclin Receptor Agonist
A Study of Ralinepag to Evaluate Effects on Exercise Capacity by CPET in Subjects With WHO Group 1 PH (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
Pivotal Trial
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
- High Blood Pressure
- Lung Disease
- Cardiovascular Disease
- Pulmonary Hypertension
- Chorioretinal Vascular Disease
- Connective Tissue Disease
- Vascular Disease
- Respiratory Diseases
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
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 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%
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%
Palpitations
11%
Upper respiratory tract infection
11%
Vomiting
11%
Iron deficiency
11%
Muscle spasms
9%
Cardiac failure
9%
Urinary tract infection
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%
Pneumonia aspiration
2%
Deep vein thrombosis
2%
COVID-19
2%
Oesophageal varices haemorrhage
2%
Atrial flutter
2%
Abdominal distension
2%
COVID-19 pneumonia
2%
Atrial fibrillation
2%
Brain abscess
2%
Breast cancer in situ
2%
Varices oesophageal
2%
Benign breast neoplasm
2%
Pleural effusion
2%
Pulmonary infarction
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
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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