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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

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
Lung Disease
Cardiovascular Disease
Pulmonary Hypertension
High Blood Pressure
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

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%

Palpitations

11%

Upper respiratory tract infection

11%

Vomiting

11%

Iron deficiency

11%

Muscle spasms

Cardiac failure

Urinary tract infection

Oedema peripheral

Pneumonia

Lower respiratory tract infection

Dyspnoea exertional

Dyspnoea

Pruritus

Hypokalaemia

Respiratory tract infection

Abdominal pain

Non-cardiac chest pain

Influenza

Bronchitis

Hyperkalaemia

Back pain

Syncope

Presyncope

Anxiety

Pulmonary arterial hypertension

Haematemesis

Cardiac arrest

COVID-19

Abdominal distension

Oesophageal varices haemorrhage

Atrial flutter

COVID-19 pneumonia

Deep vein thrombosis

Atrial fibrillation

Brain abscess

Breast cancer in situ

Varices oesophageal

Pleural effusion

Pulmonary infarction

Benign breast neoplasm

Pneumonia aspiration

Acute kidney injury

Acute respiratory failure

Arrhythmia supraventricular

Asthenia

Cardiac failure congestive

Cardiopulmonary failure

Chest pain

Clostridium difficile infection

Device related sepsis

Drug withdrawal syndrome

Epilepsy

Foot fracture

Gastroenteritis viral

Haemoptysis

Head injury

Hyponatraemia

Multiple organ dysfunction syndrome

Myositis

100%

80%

60%

40%

20%

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

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