Trial · NCT01106014
Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
NCT01106014, Phase 3, Completed, Actelion; results first posted 2016-03-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selexipag (ACT-293987) in Pulmonary Arterial Hypertension. Trials, record NCT01106014. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01106014
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
- NCT number
- NCT01106014
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,156 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Selexipag, Placebo
- First posted
- 2010-04-19
- Last updated
- 2025-10-27
- Results first posted
- 2016-03-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Up to 7 days after end of double-blind treatment (maximum: 4.3 years) | Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points). Morbidity event was defined as any of the following events confirmed by the Critical Event committee: * Hospitalization for worsening of pulmonary arterial hypertension (PAH), * Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy, * Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH, * Disease progression which was defined by a decrease in 6-minute walk distance from baseline (\>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline. Note: The number of patients at risk decreased over time but this cannot be captured below |
| Secondary | Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough | Week 26 | The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day. |
| Secondary | Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC) | Week 26 |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Up to 7 days after end of double-blind treatment (maximum: 4.3 years) | The primary endpoint was analyzed using the full analysis set, which includes all randomized patients evaluated according to the study drug to which they have been randomized (intention-to treat analysis set). | Percentage of patients free of events | NUMBER |
| SECONDARY | Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough | Week 26 | Full analysis set | Meters | MEDIAN |
| SECONDARY | Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC) | Week 26 | Full analysis set. Patients with WHO FC IV at baseline were excluded from this analysis as they could not shift to a worse category | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Selexipag | KM estimate at Month 6 | 91.2 | 95% Confidence Interval 88.5 to 93.4 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Placebo | KM estimate at Month 6 | 81.7 | 95% Confidence Interval 78.2 to 84.7 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Selexipag | KM estimate at Month 12 | 83.1 | 95% Confidence Interval 79.5 to 86.1 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Placebo | KM estimate at Month 12 | 70.6 | 95% Confidence Interval 66.6 to 74.3 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Selexipag | KM estimate at Month 18 | 75.5 | 95% Confidence Interval 71.2 to 79.2 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Placebo | KM estimate at Month 18 | 61.3 | 95% Confidence Interval 56.8 to 65.5 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Selexipag | KM estimate at Month 24 | 67.9 | 95% Confidence Interval 63.0 to 72.4 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Placebo | KM estimate at Month 24 | 53.9 | 95% Confidence Interval 49.0 to 58.5 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Selexipag | KM estimate at Month 30 | 61.9 | 95% Confidence Interval 56.3 to 66.9 | Percentage of patients free of events |
| Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake | Placebo | KM estimate at Month 30 | 49.3 | 95% Confidence Interval 44.2 to 54.3 | Percentage of patients free of events |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SELEXIPAG | 574 | |
| Overall Study | STARTED | PLACEBO | 582 | |
| Overall Study | COMPLETED | SELEXIPAG | 289 | |
| Overall Study | COMPLETED | PLACEBO | 252 | |
| Overall Study | NOT COMPLETED | SELEXIPAG | 285 | |
| Overall Study | NOT COMPLETED | PLACEBO | 330 |
Source ClinicalTrials.gov
Adverse events758
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 | ABDOMINAL PAIN | Gastrointestinal disorders | Selexipag | 44 | 575 | 54 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Placebo | 29 | 577 | 37 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Selexipag | 34 | 575 | 39 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Placebo | 32 | 577 | 38 |
| other | ANAEMIA | Blood and lymphatic system disorders | Selexipag | 43 | 575 | 53 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo | 28 | 577 | 37 |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Selexipag | 62 | 575 | 82 |
| other | ARTHRALGIA | Musculoskeletal and connective tissue disorders | Placebo | 44 | 577 | 57 |
| other | ASTHENIA | General disorders | Selexipag | 29 | 575 | 33 |
| other | ASTHENIA | General disorders | Placebo | 24 | 577 | 27 |
1 to 10 of 758Source ClinicalTrials.gov
See all 758 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selexipag | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Selexipag | 544 | 575 |
| Total, other adverse events | Placebo | 486 | 577 |
| Total, serious adverse events | Selexipag | 252 | 575 |
| Total, serious adverse events | Placebo | 272 | 577 |
Source ClinicalTrials.gov
Papers10
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Selexipag vs Placebo: serious adverse events |
Source Trial comparisons
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/NCT01106014
GET https://conductscience.org/api/trials/v1/NCT01106014/events?page=2