Who is sponsoring NCT01462565?

NCT01462565 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01462565?

Interventions in NCT01462565: current marketed FLOLAN (epoprostenol sodium), new thermo stable formulation of epoprostenol sodium.

What condition does NCT01462565 study?

NCT01462565 studies Hypertension, Pulmonary.

Is NCT01462565 still recruiting?

NCT01462565 is currently completed. Last updated 16 October 2017.

Are results published for NCT01462565?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-10-16 · How we verify

NCT01462565

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)

Completed Phase 4 Results posted Last updated 16 October 2017

What this trial tests

Phase 4 trial testing current marketed FLOLAN (epoprostenol sodium) in Hypertension, Pulmonary in 16 participants. Completed in 8 November 2012.

Timeline

1 November 2011

Primary endpoint
16 May 2012

8 November 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 November 2011
Primary completion	16 May 2012
Estimated completion	8 November 2012
Sites	8 locations across Netherlands, Canada, United States

Drugs / interventions tested

current marketed FLOLAN (epoprostenol sodium) — full drug profile →
new thermo stable formulation of epoprostenol sodium — full drug profile →

Conditions studied

Hypertension, Pulmonary — all drugs for Hypertension, Pulmonary →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 18 to 75, any sex, with Hypertension, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) Primary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3)

Subject-rated measure of health status comprised of 36 items: 8 subscale scores (physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health), 2 summary scores (physical component and mental component), and a self-evaluated change in health status. Subscale and summary scores range: 0-100. Higher subscale and summary scores was considered as better health status. Change from Baseline was calculated as score at observation minus score at baseline. Baseline was def

Physical Functioning

Group	Value	95% CI
Epoprostenol Sodium for Injection	-1.156	± 3.6593

Role-Physical

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.765	± 6.3050

Role-Emotional

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.002	± 11.1773

Vitality

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.781	± 7.1636

Mental Health

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.883	± 7.6063

Social Functioning

Group	Value	95% CI
Epoprostenol Sodium for Injection	1.706	± 7.1043

Bodily Pain

Group	Value	95% CI
Epoprostenol Sodium for Injection	3.065	± 5.8291

General Health

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.606	± 5.6068

Change From Baseline in Study Specific Participant Acceptance Survey Primary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3).

Study-specific questionnaire comprised the pre-defined15 questions which included activities of daily living assessment. Participants rated the question on a scale of 1 to 10, where 1 was do not agree and 10 was strongly agree. Change from Baseline was calculated as score at observation minus score at Baseline. Changes from Baseline was assessed for Questions 2 to 12. Baseline was defined as Visit 2 i.e. Day-14 (+ or - 7 days).

Q2- ability to perform physical activities

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.9	± 2.29

Q3- ability to perform your basic daily activies

Group	Value	95% CI
Epoprostenol Sodium for Injection	-1.5	± 1.86

Q4- ability to perform activities with your family

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.8	± 2.37

Q5- ability to participate in social activities

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.9	± 1.88

Q6- ability to comply with your Flolan treatment

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.3	± 3.34

Q7- ability to perform new activity(Jogging, walk)

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.4	± 2.00

Q8- overall satisfaction

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.4	± 1.09

Q9- interested physical activity

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.1	± 2.53

Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4 Primary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4

Dose titration requirement was assessed at the time of discharge. Change from Baseline was calculated as score at observation minus score at Baseline. Units- nanogram per kilogram per minute (ng/kg/min). Baseline was Visit 2 i.e . Day-14 (+ or - 7 days).

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.22	± 1.169

Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) Secondary · Up to visit 3 (Week 4)

An AE was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, congenital anomaly/birth defect and medically significant and all events of pos

Any AEs

Group	Value	95% CI
Epoprostenol Sodium for Injection	9

Any SAEs

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Number of Participants With Infusion Site Reactions During Treatment Period Secondary · Baseline visit (Visit 2) to Week 4 (Visit 3)

Infusion site reactions were reported during the treatment period. Infusion site was inspected for erythema, excoriation, induration, skin necrosis or signs of local sepsis.

Erythema

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Signs of local sepsis

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Other

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure Secondary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3)

Systolic blood pressure is a measure of blood pressure while the heart is beating. Diastolic blood pressure is a measure of blood pressure while the heart is relaxed. Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).

Systolic blood pressure

Group	Value	95% CI
Epoprostenol Sodium for Injection	-0.4	± 11.47

Diastolic blood pressure

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.4	± 10.99

Change From Baseline in Vital Signs at Week 4: Heart Rate Secondary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4

Summary mean change in heart rate measured in beats per minute (beats/min or BPM). Change from Baseline was calculated as the value at the indicated time points minus the value at Baseline. Baseline was Visit 2 i.e. Day-14 (+ or - 7 days).

Group	Value	95% CI
Epoprostenol Sodium for Injection	-1.7	± 8.52

Number of Participants With Abnormal Clinical Chemistry Secondary · Up to 1 week after Week 4 (Follow-up)

Abnormal clinical chemistry was analyzed as follows: serum alanine aminotransferase (ALT/SGPT) \>= 3 x upper limit of normal (ULN) , aspartate aminotransferase (AST/SGOT) \>= 3 x ULN , total bilirubin \>= 34.2, creatinine \>= 176.8.

Group	Value	95% CI
Epoprostenol Sodium for Injection	0

Number of Participants With Abnormal Hematology Secondary · Up to 1 week after Week 4 (Follow-up)

Values for hemoglobin, hematocrit, and platelet count were analyzed. Participants with abnormal values have been reported. The low and high value concern were as follows: hemoglobin (Males \< 98, \>180.0) (females \<91, \>161.0)grams per litre (g/L); hematocrit (Males \< 32.0, \>54.0) (females \<29.0, \>50.6) fraction (1); platelet count (\< 100, \> 500) gram international units per litre (gI/L).

Hemoglobin (G/L) : Week 4: high

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Hematocrit (1): Screening: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	14

Hematocrit (1): Baseline: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	15

Hematocrit (1): Week 4: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	15

Hematocrit (1): Follow-up: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Platelet count (GI/L): Screening: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	5

Platelet count (GI/L): Baseline: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	2

Platelet count (GI/L): Week 4: Low

Group	Value	95% CI
Epoprostenol Sodium for Injection	1

Number of Participants With Abnormal Urinalysis Secondary · Up to 1 week after Week 4 (Follow-up)

Dipstick method was used to measure blood, glucose and protein. Data was analyzed up to 1 week after Week 4 (Follow-up visit).

Group	Value	95% CI
Epoprostenol Sodium for Injection	0

Change From Baseline in Six Minute Walk Distance Test (6MWD) After 4-weeks of Treatment Secondary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4

This assessment was a non-encouraged test that measures the distance walked for a duration of 6 minutes. Change from Baseline was calculated as value at observation minus value at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).

Group	Value	95% CI
Epoprostenol Sodium for Injection	-3.55	± 45.321

Breathlessness After 6MWD - Borg Dyspnoea Index (BDI) Secondary · Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4

The BDI was calculated by using a 10-point scale (0 = None, 10 = Maximum) and indicates the degree of breathlessness after completion of the 6-minute walk test. The BDI scale was assessed by each participant. Change from Baseline = score at observation minus score at Baseline. Baseline visit was Visit 2 i.e. Day-14 (+ or - 7 days).

Group	Value	95% CI
Epoprostenol Sodium for Injection	0.36	± 0.535

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 1 week after Week 4 (Follow-up) for SAEs and Up to Visit 3 (Week 4) for non-serious adverse events.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Epoprostenol Sodium for Injection

Serious: 2/16 (13%)

Deaths: 0/16

Serious adverse events (2 terms)

Reaction	System	Epoprostenol Sodium for In…
Device related infection	Infections and infestations	—
Catheter site haemorrhage	General disorders	—

Other adverse events (17 terms — click to expand)

Reaction	System	Epoprostenol Sodium for In…
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Fatigue	General disorders	—
Headache	Nervous system disorders	—
Ascites	Gastrointestinal disorders	—
Paraesthesia oral	Gastrointestinal disorders	—
Oedema peripheral	General disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Muscle tightness	Musculoskeletal and connective tissue disorders	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—
Bronchitis	Infections and infestations	—
Catheter site infection	Infections and infestations	—
Ear infection	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Staphylococcal infection	Infections and infestations	—
Thyroiditis	Endocrine disorders	—
Haematoma	Vascular disorders	—

Most-reported serious reactions: Device related infection, Catheter site haemorrhage.

Data from ClinicalTrials.gov NCT01462565 adverse events section.

Sponsor's own description

The purpose of this multicentre, open label, single-arm study in approximately 20 adult patients is to evaluate the Impact on lifestyle of a new thermo stable formulation of epoprostenol sodium in subjects with Pulmonary Arterial Hypertension (PAH).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Quality of life, safety and efficacy profile of thermostable flolan in pulmonary arterial hypertension.
Provencher S, Paruchuru P, Spezzi A, Waterhouse B, et al · · 2015 · cited 6× · PMID 25793960 · DOI 10.1371/journal.pone.0120657

Verify or expand the search:

Other recruiting trials for Hypertension, Pulmonary

Currently open trials in the same condition.

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NCT05179876 — A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no O · Phase 3 · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

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NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01462565 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 16 October 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01462565.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing