Comparison · NCT00325403-d810f4a5
UT-15C (Oral Treprostinil) vs Placebo: Clinical Worsening Assessment
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. UT-15C (Oral Treprostinil) vs Placebo: Clinical Worsening Assessment. Trial comparisons, record NCT00325403-d810f4a5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00325403-d810f4a5
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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 | 0.0993 | 0.0611 | 0.157 | wilson | |
| Risk in group 2 | 0.104 | 0.0536 | 0.192 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00456 | -0.1 | 0.0723 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.956 | 0.424 | 2.16 | log | |
| Odds ratio, group 1 over group 2 | 0.951 | 0.385 | 2.35 | log | |
| Number needed to treat, for one fewer participant with the outcome on UT-15C (Oral Treprostinil) than on Placebo | 219 | 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 | UT-15C (Oral Treprostinil) | These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population. | 15 | 151 | OG001 |
| Group 2 | Placebo | These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population. | 8 | 77 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Clinical Worsening Assessment
- Description
Definition of clinical worsening included patients who met at least one of the following criteria during the 12 weeks of the study:~1. Death (all causes excluding accident)~2. Transplantation or atrial septostomy~3. Clinical deterioration as defined by:~ 1. Hospitalization as a result of PAH, or~ 2. greater than or equal to 20% decrease in 6MWD from Baseline (or too ill to walk) and a decrease in WHO functional class And~ 3. Initiation of new PAH specific therapy (i.e., ERA, PDE5-I, prostacyclin)
- Time frame
- Baseline and Week 12
- Population
Source ClinicalTrials.gov
Trial
- Title
- FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
- NCT number
- NCT00325403
- Phases
- PHASE3
- Conditions
- Pulmonary Hypertension
- Interventions
- Oral treprostinil (UT-15C) Sustained Release Tablets, Placebo
- Lead sponsor
- United Therapeutics
- Results first posted
- 2013-03-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00325403?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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