Trial · NCT01462565
Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
NCT01462565, Phase 4, Completed, GlaxoSmithKline; results first posted 2017-10-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH). Trials, record NCT01462565. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01462565
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of a New Thermo Stable Formulation of Epoprostenol Sodium to Treat Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT01462565
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 16 participants, actual
- Lead sponsor
- GlaxoSmithKline
- Conditions
- Hypertension, Pulmonary
- Interventions
- current marketed FLOLAN (epoprostenol sodium), new thermo stable formulation of epoprostenol sodium
- First posted
- 2011-10-31
- Last updated
- 2017-10-16
- Results first posted
- 2017-10-16
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | 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 defined as Visit 2 i.e. Day-14 (+ or - 7 days). |
| Primary | Change From Baseline in Study Specific Participant Acceptance Survey | 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). |
| Primary | Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4 | 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). |
| Secondary | Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) | 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 possible drug-induced liver injury with hyperbilirubinaemia. Only treatment emergent AEs and SAEs were reported in this outcome measure. Specifically, this study reported 2 SAEs, but only 1 was categorized as treatment emergent. |
| Secondary | Number of Participants With Infusion Site Reactions During Treatment Period | 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. |
| Secondary | Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure | 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). |
| Secondary | Change From Baseline in Vital Signs at Week 4: Heart Rate | 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). |
| Secondary | Number of Participants With Abnormal Clinical Chemistry | 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. |
| Secondary | Number of Participants With Abnormal Hematology | 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). |
| Secondary | Number of Participants With Abnormal Urinalysis | 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). |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3) | Intent-to-Treat (ITT) population consisted of all participants who received at least one dose of epoprostenol sodium during the Run-in period (either currently marketed epoprostenol sodium or the study drug). | Score on a scale | MEAN |
| PRIMARY | Change From Baseline in Study Specific Participant Acceptance Survey | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 (Visit 3). | ITT population. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline in Dose of Thermo Stable Epoprostenol Sodium at Week 4 | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4 | ITT population. | ng/kg/min | MEAN |
| SECONDARY | Number of Participants With Any Treatment Emergent Adverse Events (AEs) and Treatment Emergent Serious Adverse Events(SAEs) | Up to visit 3 (Week 4) | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Infusion Site Reactions During Treatment Period | Baseline visit (Visit 2) to Week 4 (Visit 3) | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Vital Signs at Week 4 : Systolic and Diastolic Blood Pressure | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) and Week 4(Visit 3) | ITT population. | Millimeter of mercury (mmHg) | MEAN |
| SECONDARY | Change From Baseline in Vital Signs at Week 4: Heart Rate | Baseline (Visit 2 i.e. Day-14 [+ or - 7 days]) to Week 4 | ITT population. | beats/min | MEAN |
| SECONDARY | Number of Participants With Abnormal Clinical Chemistry | Up to 1 week after Week 4 (Follow-up) | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Hematology | Up to 1 week after Week 4 (Follow-up) | ITT population. Only those participant available at the indicated time points were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Abnormal Urinalysis | Up to 1 week after Week 4 (Follow-up) | ITT population. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group55
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Physical Functioning | -1.156 | Standard Deviation 3.6593 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Role-Physical | -0.765 | Standard Deviation 6.3050 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Role-Emotional | 0.002 | Standard Deviation 11.1773 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Vitality | 0.781 | Standard Deviation 7.1636 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Mental Health | 0.883 | Standard Deviation 7.6063 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Social Functioning | 1.706 | Standard Deviation 7.1043 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Bodily Pain | 3.065 | Standard Deviation 5.8291 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | General Health | -0.606 | Standard Deviation 5.6068 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Physical Health Component | -0.123 | Standard Deviation 4.2876 | Score on a scale |
| Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36) | Epoprostenol Sodium for Injection | Mental Health Component | 1.141 | Standard Deviation 6.5078 | Score on a scale |
1 to 10 of 55Source ClinicalTrials.gov
See all 55 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Epoprostenol Sodium for Injection | 16 | |
| Overall Study | COMPLETED | Epoprostenol Sodium for Injection | 16 | |
| Overall Study | NOT COMPLETED | Epoprostenol Sodium for Injection | 0 |
Source ClinicalTrials.gov
Adverse events19
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Ascites | Gastrointestinal disorders | Epoprostenol Sodium for Injection | 1 | 16 | |
| other | Diarrhoea | Gastrointestinal disorders | Epoprostenol Sodium for Injection | 2 | 16 | |
| other | Nausea | Gastrointestinal disorders | Epoprostenol Sodium for Injection | 2 | 16 | |
| other | Paraesthesia oral | Gastrointestinal disorders | Epoprostenol Sodium for Injection | 1 | 16 | |
| other | Fatigue | General disorders | Epoprostenol Sodium for Injection | 2 | 16 | |
| other | Oedema peripheral | General disorders | Epoprostenol Sodium for Injection | 1 | 16 | |
| other | Back pain | Musculoskeletal and connective tissue disorders | Epoprostenol Sodium for Injection | 1 | 16 | |
| other | Muscle tightness | Musculoskeletal and connective tissue disorders | Epoprostenol Sodium for Injection | 1 | 16 | |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | Epoprostenol Sodium for Injection | 1 | 16 | |
| other | Bronchitis | Infections and infestations | Epoprostenol Sodium for Injection | 1 | 16 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Epoprostenol Sodium for Injection | 0 | 16 |
| Total, other adverse events | Epoprostenol Sodium for Injection | 9 | 16 |
| Total, serious adverse events | Epoprostenol Sodium for Injection | 2 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25793960 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01462565
GET https://conductscience.org/api/trials/v1/NCT01462565/results?page=2