Trial · NCT01338415
FUTURE 3 Study Extension
NCT01338415, Phase 3, Completed, Actelion; results first posted 2017-12-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. FUTURE 3 Study Extension. Trials, record NCT01338415. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01338415
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FUTURE 3 Study Extension
- NCT number
- NCT01338415
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 58 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Bosentan
- First posted
- 2011-04-19
- Last updated
- 2025-03-30
- Other registries' IDs
- eudract:2010-021793-12
- Results first posted
- 2017-12-11
- Limitations and caveats
The study was uncontrolled and exploratory. The main purpose of exceptional use treatment period of FUTURE 3 extension was to provide participants with bosentan beyond 12-month treatment period of FUTURE 3 extension. Providing bosentan as a study treatment required monitoring safety on an individual participant-level. No formal hypothesis was formulated, therefore results were exploratory.
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation | Up to 62 weeks in average | This is the total number of subjects with at least one adverse event (serious or not serious) whether or not causally related to the study drug and presented cumulatively in the FUTURE 3 and FUTURE 3 Extension study. NOTE: FUTURE 3 extension study was exploratory and no primary efficacy and safety endpoints were defined in the protocol. So, this safety outcome measure was selected and reported as primary endpoint here. |
| Other | Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | At Month 12 | The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement (change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study. |
| Other | Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | At Month 18 | The WHO FC indicates the severity of Pulmonary Arterial Hypertension: class I (none) to class IV (most severe). Changes from baseline to month 12 and month 18 of treatment with bosentan included: improvement (change from a higher to a lower FC), worsening (change from a lower to a higher FC) or no change/stable (same FC at baseline and at the post-baseline time point). Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study. |
| Other | Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) | At Month 12 | The GCIS is a scale used to rate the patient's current overall clinical condition ("Very Good", "Good", "Neither Good or Bad", "Bad", and "Very Bad"). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study. |
| Other | Change From Baseline up to 18 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) | At Month 18 | The GCIS is a scale used to rate the patient's current overall clinical condition ("Very Good", "Good", "Neither Good or Bad", "Bad", and "Very Bad"). Rating was performed independently by the physician and parents or legal representatives. Baseline was defined as the last valid assessment performed prior to first study drug intake in the FUTURE 3 core study. |
| Other | Number of Patients With Pulmonary Arterial Hypertension (PAH) Worsening Components up to the Last Day of Treatment + 7 Days | Up to 62 weeks in average | Number of patients with at least one PAH-worsening component (death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH, new/worsening right heart failure) reported cumulatively over FUTURE 3 core and extension study. |
| Other | Pulmonary Arterial Hypertension (PAH) Progression up to End of Treatment + 7 Days | From baseline to Month 18 | PAH progression was defined by time elapsed from the first study drug administration in the FUTURE core study to the day of the first occurrence of any of the following PAH worsening events: death, lung transplant, hospitalization due to PAH progression, initiation of new therapy for PAH or new / worsening right heart failure. Subjects without a PAH worsening event were censored at EOT + 7 days. PAH progression was estimated by Kaplan-Meier methodology and expressed by the percentage of participants free of events at different time points. |
| Other | Overall Survival | From baseline to month 18 | Overall survival was defined as the time elapsed between the first study drug administration and death (any cause) up to end of study (Month 18 survival follow-up), regardless of whether the patient was on study treatment. Patients who died, regardless of the cause of death, were considered to have had an event. Patients last known to have been alive were censored on their date of last contact. Percentage of participants without death at different time points was estimated using Kaplan-Meier methodology. |
| Other | Exceptional Use Treatment Period (EUTP): Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. |
| Other | EUTP: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation | Up to 62 weeks in average | The analysis was performed on the Safety population analysis set, including all patients who received at least one dose of study treatment and evaluated according to the study treatment that they received. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | At Month 12 | The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | At Month 18 | The intent to treat population was used. Where a missing visit score exists between two visits with scores, the missing score was imputed with the worse score of the non-missing scores; if the missing score was not between 2 visits with scores, it was replaced by the last non-missing score. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 12 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) | At Month 12 | The intent to treat population was used for these analyses. No imputation method was used. Only patients with available results at the corresponding time point are included in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Change From Baseline up to 18 Months of Study Treatment in the Global Clinical Impression Scale (GCIS) | At Month 18 | The intent to treat population was used. No imputation method was used. Only patients with available results at the corresponding time point are including in the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Patients With Pulmonary Arterial Hypertension (PAH) Worsening Components up to the Last Day of Treatment + 7 Days | Up to 62 weeks in average | The intent to treat population was used | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Pulmonary Arterial Hypertension (PAH) Progression up to End of Treatment + 7 Days | From baseline to Month 18 | These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study | Percentage of patients free of events | NUMBER |
| OTHER_PRE_SPECIFIED | Overall Survival | From baseline to month 18 | These are the numbers of patients at risk at the time of study treatment initiation in the FUTURE 3 core study | Percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Exceptional Use Treatment Period (EUTP): Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | EUTP: Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) up to 7 Days After Permanent Discontinuation of Study Drug | Up to 7 days after discontinuation of study drug (up to 3 years and 4 months) | Exceptional-use set included all patients who entered the EUTP. Due to change in study conduct, patients treated with bosentan t.i.d. switched to b.i.d. after local Amendment B to global protocol version 2 (17 March 2015 for Belarus and Ukraine, 1 April 2015 for China) and displaying summaries in the EUTP period by dose were not significant. Therefore, the results were reported combined for bosentan b.i.d./t.i.d. | percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation | Bosentan 2mg/kg b.i.d. | 29 | Participants | ||
| Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation | Bosentan 2mg/kg t.i.d. | 26 | Participants | ||
| Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg b.i.d. | Stable WHO FC | 22 | Participants | |
| Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg t.i.d. | Stable WHO FC | 25 | Participants | |
| Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg b.i.d. | Improved WHO FC | 7 | Participants | |
| Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg t.i.d. | Improved WHO FC | 3 | Participants | |
| Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg b.i.d. | Worsened WHO FC | 4 | Participants | |
| Change From Baseline up to 12 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg t.i.d. | Worsened WHO FC | 3 | Participants | |
| Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg b.i.d. | Stable WHO FC | 25 | Participants | |
| Change From Baseline up to 18 Months of Study Treatment in the World Health Organization Functional Classification (WHO FC) | Bosentan 2mg/kg t.i.d. | Stable WHO FC | 25 | Participants |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Core + Extension | STARTED | Bosentan 2mg/kg b.i.d. | 33 | |
| Core + Extension | STARTED | Bosentan 2mg/kg t.i.d. | 31 | |
| Core + Extension | STARTED | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 0 | |
| Core + Extension | Enrolled in FUTURE 3 Extension | Bosentan 2mg/kg b.i.d. | 31 | |
| Core + Extension | Enrolled in FUTURE 3 Extension | Bosentan 2mg/kg t.i.d. | 27 | |
| Core + Extension | Enrolled in FUTURE 3 Extension | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 0 | |
| Core + Extension | COMPLETED | Bosentan 2mg/kg b.i.d. | 23 | |
| Core + Extension | COMPLETED | Bosentan 2mg/kg t.i.d. | 22 | |
| Core + Extension | COMPLETED | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 0 | |
| Core + Extension | NOT COMPLETED | Bosentan 2mg/kg b.i.d. | 10 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events282
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 | Bosentan 2mg/kg b.i.d. | 1 | 33 | 1 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Bosentan 2mg/kg t.i.d | 2 | 31 | 2 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 0 | 10 | 0 |
| other | ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | Bosentan 2mg/kg b.i.d. | 0 | 33 | 0 |
| other | ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | Bosentan 2mg/kg t.i.d | 2 | 31 | 2 |
| other | ACCIDENTAL OVERDOSE | Injury, poisoning and procedural complications | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 0 | 10 | 0 |
| other | BLOOD BILIRUBIN INCREASED | Investigations | Bosentan 2mg/kg b.i.d. | 2 | 33 | 2 |
| other | BLOOD BILIRUBIN INCREASED | Investigations | Bosentan 2mg/kg t.i.d | 1 | 31 | 1 |
| other | BLOOD BILIRUBIN INCREASED | Investigations | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 1 | 10 | 1 |
| other | BRONCHITIS | Infections and infestations | Bosentan 2mg/kg b.i.d. | 3 | 33 | 4 |
1 to 10 of 282Source ClinicalTrials.gov
See all 282 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosentan 2mg/kg b.i.d. | 8 | 33 |
| Total, all-cause mortality | Bosentan 2mg/kg t.i.d | 4 | 31 |
| Total, all-cause mortality | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 1 | 10 |
| Total, other adverse events | Bosentan 2mg/kg b.i.d. | 24 | 33 |
| Total, other adverse events | Bosentan 2mg/kg t.i.d | 23 | 31 |
| Total, other adverse events | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 8 | 10 |
| Total, serious adverse events | Bosentan 2mg/kg b.i.d. | 15 | 33 |
| Total, serious adverse events | Bosentan 2mg/kg t.i.d | 13 | 31 |
| Total, serious adverse events | Bosentan 2mg/kg b.i.d or t.i.d. During EUTP | 4 | 10 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Bosentan 2mg/kg b.i.d. vs Bosentan 2mg/kg t.i.d.: Treatment Emergent Adverse Events (AEs) up to 7 Days After Permanent Study Drug Discontinuation |
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/NCT01338415
GET https://conductscience.org/api/trials/v1/NCT01338415/results?page=2