Comparison · NCT04271475-3b4c4e2e
Double Blind (DB) Period: Macitentan vs DB Period: Placebo: Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Double Blind (DB) Period: Macitentan vs DB Period: Placebo: Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28. Trial comparisons, record NCT04271475-3b4c4e2e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04271475-3b4c4e2e
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.189 | 0.0948 | 0.342 | wilson | |
| Risk in group 2 | 0.14 | 0.0656 | 0.273 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0497 | -0.114 | 0.219 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.36 | 0.5 | 3.68 | log | |
| Odds ratio, group 1 over group 2 | 1.44 | 0.437 | 4.74 | log | |
| Number needed to treat, for one more participant with the outcome on Double Blind (DB) Period: Macitentan than on DB Period: Placebo | 20.1 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Double Blind (DB) Period: Macitentan | During the 8-week up-titration phase, participants received macitentan doses orally once daily (QD): 10 mg tablet for 4 weeks followed by 37.5 mg tablet for another 4 weeks prior to reaching the target maintenance phase dose of macitentan 75 mg QD. Participants were to remain on double-blind maintenance treatment until the last participant randomized completed the Week 28 visit. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter post-treatment observation period (PTOP) from DB period last dose until Week 28. Median exposure to DB treatment was 24.50 weeks (minimum: 3.9 weeks; maximum: 160.4 weeks). | 7 | 37 | OG000 |
| Group 2 | DB Period: Placebo | Participants received placebo matched to macitentan dose levels during the DB treatment period. Participants who prematurely discontinued DB study treatment prior to Week 28 but did not withdraw consent were asked to enter PTOP from DB period last dose until Week 28. Median exposure to DB treatment was 44 weeks (minimum: 4 weeks; maximum: 147.9 weeks). | 6 | 43 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Improvement in World Health Organization Functional Class (WHO FC) From Baseline to Week 28
- Description
Number of participants with improvement in WHO FC from baseline to Week 28 were reported. Improvement (decrease) in WHO FC from baseline to Week 28 was calculated for each participant. WHO FC test was used to assess disease severity. Four functional classes (FC) were defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). For the analysis purpose, these WHO FC class values were transformed to a scale with scores ranged from 1 to 4; where a score of 1 corresponded to WHO FC Class I and a score of 4 corresponded to WHO FC Class IV. The higher scores indicate greater symptom severity or worse impact. Improvement was considered when a participant changed from a higher class to a lower class.
- Time frame
- From Baseline (Day 1) up to Week 28
- Population
FAS included all randomized participants assigned to a study intervention and were analyzed according to the intervention they had been assigned to via IWRS. Here, 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension
- NCT number
- NCT04271475
- Phases
- PHASE3
- Conditions
- Chronic Thromboembolic Pulmonary Hypertension
- Interventions
- Macitentan, Placebo
- Lead sponsor
- Actelion
- Results first posted
- 2025-04-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04271475?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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