Trial · NCT02508649
Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
NCT02508649, Phase 2, Phase 3, Terminated, Ferring Pharmaceuticals; results first posted 2021-04-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial. Trials, record NCT02508649. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02508649
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selepressin Evaluation Programme for Sepsis-Induced Shock - Adaptive Clinical Trial
- NCT number
- NCT02508649
- Status
- Terminated
- Phases
- Phase 2, Phase 3
- Enrollment
- 868 participants, actual
- Lead sponsor
- Ferring Pharmaceuticals
- Conditions
- Septic Shock
- Interventions
- selepressin, placebo
- First posted
- 2015-07-27
- Last updated
- 2021-04-06
- Other registries' IDs
- eudract:2014-003973-41
- Results first posted
- 2021-04-06
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vasopressor- and Mechanical Ventilator-free Days (PVFDs) | Up to Day 30 | Composite endpoint defined as number of days from start of treatment to 30 days thereafter during which subject is: 1. Alive. However, if patient dies within these 30-days then PVFDs will be zero even if there is a period during which subject is alive and free of both vasopressor treatment and mechanical ventilation; 2. Free of treatment with vasopressors: Less than 60 min during any contiguous 24-h period. If a patient requires vasopressors longer than 60 min in total during any 24-h period, the intervening intervals during which they are free of vasopressors will not be included in the determination of PVFDs; 3. Free of any mechanical ventilation: Less than 60 min during any contiguous 24-h period. If a patient requires mechanical ventilation longer than 60 min in total during any 24-h period, the intervening intervals during which they are not receiving mechanical ventilation will not be included in the period free of mechanical ventilation in the determination of PVFDs. |
| Secondary | All-cause Mortality | At Day 90 | All-cause mortality defined as the percentage of subjects that have died, regardless of cause. |
| Secondary | Renal Replacement Therapy (RRT)-Free Days | Up to Day 30 | RRT-free days was defined as the number of days a subject is free of treatment with any form of RRT (continuous RRT, intermittent hemodialysis or peritoneal dialysis) and the intermittent periods were not included. RRT-free days was analyzed excluding subjects on RRT for chronic renal failure at time of randomization. |
| Secondary | Intensive Care Unit (ICU)-Free Days | Up to Day 30 | The ICU free days, as for the PVFDs, reflect the time from last discharge of the ICU to Day 30 with an absolute penalty for mortality, i.e., any subject that died within this 30-day period was assigned zero value). |
| Secondary | Vasopressor-free Days up to Day 30 | Up to Day 30 | Number of days from start of treatment to 30 days thereafter during which the subject is free of treatment with vasopressors, i.e. less than 60 min during any contiguous 24-h period. |
| Secondary | Mechanical Ventilator-free Days up to Day 30 | Up to Day 30 | Number of days from start of treatment to 30 days thereafter during which the subject is free of any mechanical ventilation, i.e. less than 60 min during any contiguous 24-h period. |
| Secondary | Duration of Septic Shock (i.e. Vasopressor Use) up to Day 30 | Up to Day 30 | The duration of septic shock was defined as the cumulative periods (\>1 h), from start of investigational medicinal product (IMP) treatment until Day 30, on IMP or vasopressors. |
| Secondary | Duration of Mechanical Ventilation up to Day 30 | Up to Day 30 | The duration of mechanical ventilation was defined as the cumulative periods (\>1 h), from start of the IMP treatment until Day 30, on mechanical ventilation. |
| Secondary | The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization) | Up to Day 30 | Renal replacement therapy is defined as continuous RRT, intermittent hemodialysis, or peritoneal dialysis. In order to ensure that any reduction in the incidence of RRT was not caused by an increase in mortality, all subjects dying within the 30-day period were counted as on RRT. |
| Secondary | Duration of RRT up to Day 90 (Excluding Subjects on RRT for Chronic Failure at the Time of Randomization) | Up to Day 90 | The duration of RRT was defined as the cumulative periods (\>1 h) from start of IMP until Day 90 with RRT (continuous renal replacement therapy, intermittent hemodialysis, or peritoneal dialysis). Subjects on RRT for chronic renal failure at time of randomization were not included in the analysis. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Vasopressor- and Mechanical Ventilator-free Days (PVFDs) | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | days | LEAST_SQUARES_MEAN |
| SECONDARY | All-cause Mortality | At Day 90 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | percentage of subjects | NUMBER |
| SECONDARY | Renal Replacement Therapy (RRT)-Free Days | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Intensive Care Unit (ICU)-Free Days | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. The primary comparison to determine statistical and clinical significance was between all subjects in all selepressin arms (pooled together and treated as a single arm) and all subjects in the placebo arm, to control Type 1 error. | days | LEAST_SQUARES_MEAN |
| SECONDARY | Vasopressor-free Days up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | Mechanical Ventilator-free Days up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | Duration of Septic Shock (i.e. Vasopressor Use) up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | Duration of Mechanical Ventilation up to Day 30 | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEDIAN |
| SECONDARY | The Percentage of Subjects With RRT up to Day 30 (Counting Subjects Who Died as on RRT and Excluding Subjects on RRT for Chronic Renal Failure at the Time of Randomization) | Up to Day 30 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of RRT up to Day 90 (Excluding Subjects on RRT for Chronic Failure at the Time of Randomization) | Up to Day 90 | The FAS comprised of all subjects who were enrolled (i.e. randomized \[as planned\]) and dosed. | days | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group342
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Vasopressor- and Mechanical Ventilator-free Days (PVFDs) | Placebo | 14.45 | 95% Confidence Interval 12.82 to 16.09 | days | |
| Vasopressor- and Mechanical Ventilator-free Days (PVFDs) | Selepressin Pooled | 15.00 | 95% Confidence Interval 13.77 to 16.23 | days | |
| All-cause Mortality | Placebo | 39.44 | percentage of subjects | ||
| All-cause Mortality | Selepressin Pooled | 40.59 | percentage of subjects | ||
| Renal Replacement Therapy (RRT)-Free Days | Placebo | 18.21 | 95% Confidence Interval 16.14 to 20.29 | days | |
| Renal Replacement Therapy (RRT)-Free Days | Selepressin Pooled | 18.50 | 95% Confidence Interval 17.03 to 19.98 | days | |
| Intensive Care Unit (ICU)-Free Days | Placebo | 12.15 | 95% Confidence Interval 10.66 to 13.64 | days | |
| Intensive Care Unit (ICU)-Free Days | Selepressin Pooled | 12.64 | 95% Confidence Interval 11.51 to 13.76 | days | |
| Vasopressor-free Days up to Day 30 | Placebo | 25.30 | Inter-Quartile Range 0.00 to 28.30 | days | |
| Vasopressor-free Days up to Day 30 | Selepressin 2.5 ng/kg/Min | 25.60 | Inter-Quartile Range 0.00 to 28.60 | days |
1 to 10 of 342Source ClinicalTrials.gov
See all 342 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 283 | |
| Overall Study | STARTED | Selepressin 2.5 ng/kg/Min | 197 | |
| Overall Study | STARTED | Selepressin 3.75 ng/kg/Min | 189 | |
| Overall Study | STARTED | Selepressin 5.25 ng/kg/Min | 199 | |
| Overall Study | Dosed | Placebo | 266 | |
| Overall Study | Dosed | Selepressin 2.5 ng/kg/Min | 191 | |
| Overall Study | Dosed | Selepressin 3.75 ng/kg/Min | 177 | |
| Overall Study | Dosed | Selepressin 5.25 ng/kg/Min | 194 | |
| Overall Study | COMPLETED | Placebo | 265 | |
| Overall Study | COMPLETED | Selepressin 2.5 ng/kg/Min | 184 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events570
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 | Thrombocytopenia | Blood and lymphatic system disorders | Placebo | 12 | 266 | 13 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Selepressin 2.5 ng/kg/Min | 9 | 191 | 9 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Selepressin 3.75 ng/kg/Min | 10 | 177 | 10 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Selepressin 5.25 ng/kg/Min | 11 | 194 | 11 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Selepressin Pooled | 30 | 562 | 30 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 24 | 266 | 25 |
| other | Anaemia | Blood and lymphatic system disorders | Selepressin 2.5 ng/kg/Min | 12 | 191 | 13 |
| other | Anaemia | Blood and lymphatic system disorders | Selepressin 3.75 ng/kg/Min | 6 | 177 | 6 |
| other | Anaemia | Blood and lymphatic system disorders | Selepressin 5.25 ng/kg/Min | 7 | 194 | 7 |
| other | Anaemia | Blood and lymphatic system disorders | Selepressin Pooled | 25 | 562 | 26 |
1 to 10 of 570Source ClinicalTrials.gov
See all 570 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 116 | 266 |
| Total, all-cause mortality | Selepressin 2.5 ng/kg/Min | 80 | 191 |
| Total, all-cause mortality | Selepressin 3.75 ng/kg/Min | 76 | 177 |
| Total, all-cause mortality | Selepressin 5.25 ng/kg/Min | 85 | 194 |
| Total, all-cause mortality | Selepressin Pooled | 241 | 562 |
| Total, other adverse events | Placebo | 94 | 266 |
| Total, other adverse events | Selepressin 2.5 ng/kg/Min | 54 | 191 |
| Total, other adverse events | Selepressin 3.75 ng/kg/Min | 63 | 177 |
| Total, other adverse events | Selepressin 5.25 ng/kg/Min | 60 | 194 |
| Total, other adverse events | Selepressin Pooled | 177 | 562 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02508649
GET https://conductscience.org/api/trials/v1/NCT02508649/results?page=2