Trial · NCT00903331
Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
NCT00903331, Phase 2, Completed, Actelion; results first posted 2014-02-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study. Trials, record NCT00903331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00903331
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Macitentan Use in an Idiopathic Pulmonary Fibrosis Clinical Study
- NCT number
- NCT00903331
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 178 participants, actual
- Lead sponsor
- Actelion
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- ACT-064992 (macitentan), Placebo
- First posted
- 2009-05-18
- Last updated
- 2014-02-17
- Results first posted
- 2014-02-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Forced Vital Capacity (FVC) at Baseline and End of Period 1 | 12 months | FVC was measured at baseline and at the end of Period 1. The same equipment and tester were used during the course of the study. The equipment was calibrated and the calibration documented prior to each patient's measurement. The person responsible for conducting the pulmonary function tests was required to comply with the study guidelines and the American Thoracic Society/European Respiratory Society joint criteria on lung function testing. |
| Secondary | Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | Up to end of study (Up to 24 months) | Disease worsening was indicated by pulmonary function test/idiopathic pulmonary fibrosis worsening (PFT/IPF) or acute respiratory decompensation of IPF. PFT/IPF worsening was indicated by the occurrence of both of the following: confirmed by two tests at least 4 weeks apart, as defined by the occurrence of both of the following: decrease from baseline ≥ 10% in forced vital capacity and decrease from baseline ≥ 15% in corrected diffusing capacity of the lung for carbon monoxide. Acute respiratory decompensation of IPF was defined as an unexplained rapid deterioration (over a period of less than 4 weeks) of the patient's condition with increasing shortness of breath requiring oxygen supplementation ≥ 5 L/min to maintain a resting oxygen saturation ≥ 90% or arterial oxygen pressure ≥ 55 mmHg (sea level) or 50 mmHg (high altitude). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Forced Vital Capacity (FVC) at Baseline and End of Period 1 | 12 months | All randomized patients | litres | MEDIAN |
| SECONDARY | Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | Up to end of study (Up to 24 months) | All randomized patients | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Forced Vital Capacity (FVC) at Baseline and End of Period 1 | Placebo | Baseline | 2.74 | 95% Confidence Interval 0.776 | litres |
| Forced Vital Capacity (FVC) at Baseline and End of Period 1 | ACT-064922 | Baseline | 2.83 | 95% Confidence Interval 0.834 | litres |
| Forced Vital Capacity (FVC) at Baseline and End of Period 1 | Placebo | End of Period 1 | 2.40 | 95% Confidence Interval 0.918 | litres |
| Forced Vital Capacity (FVC) at Baseline and End of Period 1 | ACT-064922 | End of Period 1 | 2.57 | 95% Confidence Interval 1.012 | litres |
| Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | Placebo | Patients at Risk of Event at Month 4 | 59 | participants | |
| Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | ACT-064922 | Patients at Risk of Event at Month 4 | 112 | participants | |
| Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | Placebo | Patients at Risk of Event at Month 8 | 57 | participants | |
| Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | ACT-064922 | Patients at Risk of Event at Month 8 | 103 | participants | |
| Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | Placebo | Patients at Risk of Event at Month 12 | 44 | participants | |
| Number of Patients at Risk of Event of Disease Worsening or Death up to the End of Study | ACT-064922 | Patients at Risk of Event at Month 12 | 81 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 59 | |
| Overall Study | STARTED | ACT-064922 | 119 | |
| Overall Study | COMPLETED | Placebo | 54 | |
| Overall Study | COMPLETED | ACT-064922 | 101 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | ACT-064922 | 18 |
Source ClinicalTrials.gov
Adverse events200
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 | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 59 | |
| other | DYSPNOEA | Respiratory, thoracic and mediastinal disorders | ACT-064922 | 24 | 119 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | Placebo | 21 | 59 | |
| other | COUGH | Respiratory, thoracic and mediastinal disorders | ACT-064922 | 22 | 119 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Placebo | 12 | 59 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | ACT-064922 | 20 | 119 | |
| other | IDIOPATHIC PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | Placebo | 10 | 59 | |
| other | IDIOPATHIC PULMONARY FIBROSIS | Respiratory, thoracic and mediastinal disorders | ACT-064922 | 17 | 119 | |
| other | BRONCHITIS | Infections and infestations | Placebo | 9 | 59 | |
| other | BRONCHITIS | Infections and infestations | ACT-064922 | 16 | 119 |
1 to 10 of 200Source ClinicalTrials.gov
See all 200 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | ACT-064922 | ||
| Total, other adverse events | Placebo | 57 | 59 |
| Total, other adverse events | ACT-064922 | 114 | 119 |
| Total, serious adverse events | Placebo | 20 | 59 |
| Total, serious adverse events | ACT-064922 | 37 | 119 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23682110 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ACT-064922 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/NCT00903331
GET https://conductscience.org/api/trials/v1/NCT00903331/events?page=2