Trial Outcomes & Findings for Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension (NCT NCT01470144)
NCT ID: NCT01470144
Last Updated: 2025-02-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
41 participants
Primary outcome timeframe
On average 2.72 years
Results posted on
2025-02-04
Participant Flow
Extension study for patients who completed EPITOME-2 (AC-066A301). Patients continued to receive EFI (epoprostenol sodium). In 6 countries (FR, CA, BE, NL, IT, ES) at 8 expert centers for the treatment of patients with pulmonary arterial hypertension. Recruitment started on 15 June 2011 and was completed on 02 February 2012.
Participant milestones
| Measure |
Treatment
All patients who received at least one dose of EFI
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Treatment
All patients who received at least one dose of EFI
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Lung transplant
|
6
|
|
Overall Study
Patient's and investigator's decision
|
1
|
Baseline Characteristics
Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension
Baseline characteristics by cohort
| Measure |
Treatment
n=41 Participants
All patients who received at least one dose of EFI
|
|---|---|
|
Age, Continuous
|
46.0 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: On average 2.72 yearsPopulation: All patients who received at least one dose of EFI
Outcome measures
| Measure |
Treatment
n=41 Participants
All patients who received at least one dose of EFI
|
|---|---|
|
Treatment-emergent Adverse Events
|
41 Number of patients
|
SECONDARY outcome
Timeframe: On average 2.72 yearsDuration of exposure to EFI
Outcome measures
| Measure |
Treatment
n=41 Participants
All patients who received at least one dose of EFI
|
|---|---|
|
Exposure Duration
|
2.44 year
Interval 0.5 to 4.0
|
Adverse Events
Treatment
Serious events: 35 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment
n=41 participants at risk
All patients who received at least one dose of EFI
|
|---|---|
|
Infections and infestations
Catheter site infection
|
17.1%
7/41 • Number of events 10 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
17.1%
7/41 • Number of events 7 • On average 2.72 years
|
|
Surgical and medical procedures
Lung transplant
|
14.6%
6/41 • Number of events 6 • On average 2.72 years
|
|
Cardiac disorders
Right ventricular failure
|
14.6%
6/41 • Number of events 11 • On average 2.72 years
|
|
General disorders
Device dislocation
|
9.8%
4/41 • Number of events 6 • On average 2.72 years
|
|
Infections and infestations
Device related sepsis
|
9.8%
4/41 • Number of events 5 • On average 2.72 years
|
|
General disorders
Device occlusion
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Cardiac disorders
Angina pectoris
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
General disorders
Device alarm issue
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
General disorders
Device damage
|
4.9%
2/41 • Number of events 3 • On average 2.72 years
|
|
Gastrointestinal disorders
Device leakage
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
Infections and infestations
Device related infection
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
Nervous system disorders
Syncope
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
Investigations
Transplant evaluation
|
4.9%
2/41 • Number of events 2 • On average 2.72 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Investigations
Brain natriuretic peptide increased
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Infections and infestations
Bronchitis moraxella
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Cardiac disorders
Cardiac flutter
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Infections and infestations
Catheter site cellulitis
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Catheter site pain
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Chest pain
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Cardiac disorders
Coronary artery stenosis
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Device breakage
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Device connection issue
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Infections and infestations
Diverticulitis
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Nervous system disorders
Dizziness
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Infusion site vesicles
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Nervous system disorders
Loss of consciousness
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Surgical and medical procedures
Medical device change
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Infections and infestations
Pneumonia primary atypical
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Pyrexia
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Vascular disorders
Shock haemorrhagic
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
Cardiac disorders
Sinus arrhythmia
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
|
General disorders
Sudden death
|
2.4%
1/41 • Number of events 1 • On average 2.72 years
|
Other adverse events
| Measure |
Treatment
n=41 participants at risk
All patients who received at least one dose of EFI
|
|---|---|
|
Nervous system disorders
Headache
|
29.3%
12/41 • Number of events 15 • On average 2.72 years
|
|
Infections and infestations
Nasopharyngitis
|
24.4%
10/41 • Number of events 14 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
22.0%
9/41 • Number of events 10 • On average 2.72 years
|
|
Gastrointestinal disorders
Diarrhoea
|
24.4%
10/41 • Number of events 14 • On average 2.72 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
24.4%
10/41 • Number of events 10 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
10/41 • Number of events 10 • On average 2.72 years
|
|
General disorders
Fatigue
|
19.5%
8/41 • Number of events 8 • On average 2.72 years
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
9.8%
4/41 • Number of events 4 • On average 2.72 years
|
|
Infections and infestations
Bronchitis
|
19.5%
8/41 • Number of events 14 • On average 2.72 years
|
|
Gastrointestinal disorders
Nausea
|
17.1%
7/41 • Number of events 8 • On average 2.72 years
|
|
Cardiac disorders
Palpitations
|
12.2%
5/41 • Number of events 8 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.2%
5/41 • Number of events 7 • On average 2.72 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.6%
6/41 • Number of events 11 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.6%
6/41 • Number of events 6 • On average 2.72 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
12.2%
5/41 • Number of events 6 • On average 2.72 years
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
4/41 • Number of events 4 • On average 2.72 years
|
|
Infections and infestations
Gastroenteritis
|
9.8%
4/41 • Number of events 5 • On average 2.72 years
|
|
General disorders
Oedema peripheral
|
9.8%
4/41 • Number of events 5 • On average 2.72 years
|
|
General disorders
Pyrexia
|
9.8%
4/41 • Number of events 4 • On average 2.72 years
|
|
Gastrointestinal disorders
Vomiting
|
12.2%
5/41 • Number of events 6 • On average 2.72 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.8%
4/41 • Number of events 6 • On average 2.72 years
|
|
Infections and infestations
Catheter site infection
|
9.8%
4/41 • Number of events 6 • On average 2.72 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Nervous system disorders
Dizziness
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Psychiatric disorders
Anxiety
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41 • Number of events 4 • On average 2.72 years
|
|
General disorders
Asthenia
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.3%
3/41 • Number of events 4 • On average 2.72 years
|
|
Psychiatric disorders
Insomnia
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Infections and infestations
Sinusitis
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
|
Investigations
Weight decreased
|
7.3%
3/41 • Number of events 3 • On average 2.72 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60