Trial · NCT01112306
ACT-293987 in Pulmonary Arterial Hypertension
NCT01112306, Phase 3, Completed, Actelion; results first posted 2022-09-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ACT-293987 in Pulmonary Arterial Hypertension. Trials, record NCT01112306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01112306
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ACT-293987 in Pulmonary Arterial Hypertension
- NCT number
- NCT01112306
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 709 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- ACT-293987
- First posted
- 2010-04-28
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2009-014992-31
- Results first posted
- 2022-09-19
- Limitations and caveats
The study had an open-label, uncontrolled design. Additional pulmonary arterial hypertension (PAH)-specific treatments were introduced in a limited percentage of participants and during a limited period of time. The study had a variable study duration across countries/territories depending on the availability of commercial selexipag. Limited safety data reporting was done in participants in China due to the human genetic resources (HGR) regulation finding after 20-December-2019.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation | Up to 3 days after study drug discontinuation (Up to 10.5 years) | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug. |
| Primary | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation | Up to 3 days after study drug discontinuation (Up to 10.5 years) | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Those SAEs occurring during study drug administration, that is, between study drug initiation and three days after study drug discontinuation, are defined as treatment-emergent SAEs. |
| Primary | Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention | Up to 10.5 years | An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. A TEAE is any AE temporally associated with the use of study drug (from study drug initiation until 3 days after study drug discontinuation), whether or not considered related to the study drug. |
| Secondary | Percentage of Alive Participants | Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | Percentage of alive participants were analyzed using Kaplan-Meier (KM) estimates. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation | Up to 3 days after study drug discontinuation (Up to 10.5 years) | The open label (OL) safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation | Up to 3 days after study drug discontinuation (Up to 10.5 years) | The OL safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention | Up to 10.5 years | The OL safety analysis set included all randomized participants who received at least 1 dose of selexipag or placebo in main GRIPHON study (AC-065A302; NCT01106014) and entered to this current GRIPHON OL study (AC-065A303; NCT01112306). Participants who did not enter GRIPHON OL were not in the scope of the OL safety analysis set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Alive Participants | Baseline (Day 1), Months 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120 | Selexipag-treated set (STS): all participants who received at least 1 dose of selexipag in either main study (NCT01106014) or this OL study (NCT01112306). Survival analysis was planned in a subset of STS participants who received selexipag in main study, entered or did not enter this OL study. Here, n (number analyzed): participants at risk (alive and on study), analyzed at each specified timepoint. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) up to 3 Days After Study Intervention Discontinuation | Selexipag | 684 | Participants | ||
| Number of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 3 Days After Study Intervention Discontinuation | Selexipag | 420 | Participants | ||
| Number of Participants With TEAEs Leading to Permanent Discontinuation of Study Intervention | Selexipag | 129 | Participants | ||
| Percentage of Alive Participants | Selexipag | KM estimate at Baseline (Day 1) | 100 | 95% Confidence Interval 100 to 100 | Percentage of participants |
| Percentage of Alive Participants | Selexipag | KM estimate at Month 3 | 98.4 | 95% Confidence Interval 97.0 to 99.2 | Percentage of participants |
| Percentage of Alive Participants | Selexipag | KM estimate at Month 6 | 96.3 | 95% Confidence Interval 94.4 to 97.6 | Percentage of participants |
| Percentage of Alive Participants | Selexipag | KM estimate at Month 9 | 94.0 | 95% Confidence Interval 91.7 to 95.7 | Percentage of participants |
| Percentage of Alive Participants | Selexipag | KM estimate at Month 12 | 92.0 | 95% Confidence Interval 89.4 to 94.0 | Percentage of participants |
| Percentage of Alive Participants | Selexipag | KM estimate at Month 24 | 85.3 | 95% Confidence Interval 82.0 to 88.0 | Percentage of participants |
| Percentage of Alive Participants | Selexipag | KM estimate at Month 36 | 79.3 | 95% Confidence Interval 75.4 to 82.6 | Percentage of participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selexipag | 709 | |
| Overall Study | COMPLETED | Selexipag | 424 | |
| Overall Study | NOT COMPLETED | Selexipag | 285 |
Source ClinicalTrials.gov
Adverse events370
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 | Anaemia | Blood and lymphatic system disorders | Selexipag | 65 | 709 | |
| other | Palpitations | Cardiac disorders | Selexipag | 43 | 709 | |
| other | Diarrhoea | Gastrointestinal disorders | Selexipag | 209 | 709 | |
| other | Nausea | Gastrointestinal disorders | Selexipag | 135 | 709 | |
| other | Vomiting | Gastrointestinal disorders | Selexipag | 74 | 709 | |
| other | Fatigue | General disorders | Selexipag | 44 | 709 | |
| other | Oedema Peripheral | General disorders | Selexipag | 90 | 709 | |
| other | Bronchitis | Infections and infestations | Selexipag | 59 | 709 | |
| other | Nasopharyngitis | Infections and infestations | Selexipag | 88 | 709 | |
| other | Upper Respiratory Tract Infection | Infections and infestations | Selexipag | 84 | 709 |
1 to 10 of 370Source ClinicalTrials.gov
See all 370 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selexipag | 186 | 709 |
| Total, other adverse events | Selexipag | 598 | 709 |
| Total, serious adverse events | Selexipag | 420 | 709 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34727317 | 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/NCT01112306
GET https://conductscience.org/api/trials/v1/NCT01112306/events?page=2