Comparison · NCT01884675-c595eb6c
Ambrisentan 5mg vs Placebo: Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Ambrisentan 5mg vs Placebo: Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH). Trial comparisons, record NCT01884675-c595eb6c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01884675-c595eb6c
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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 | 0 | 0.184 | wilson | |
| Risk in group 2 | 0 | 0 | 0.194 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.194 | 0.184 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ambrisentan 5mg | Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks. | 0 | 17 | OG001 |
| Group 2 | Placebo | Participants received a matching placebo tablet once daily for a period of 16 weeks. | 0 | 16 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Clinical Worsening of Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- Description
Clinical worsening of CTEPH is defined by the time from randomization to the first occurrence of death, lung transplantation, hospitalization for CTEPH, atrial septostomy, addition of parenteral prostanoids, or study withdrawal due to two or more early escape criteria included: a decrease from Baseline of at least 20 percent in the distance walked during the six-minute walk test; an increase of one or more WHO functional class; worsening right ventricular failure (e.g., as indicated by increased jugular venous pressure; new/worsening hepatomegaly, ascites, or peripheral edema; worsening echocardiographic parameters such as tricuspid annulus plane systolic excursion (TAPSE) and Tissue Doppler Imaging of the tricuspid annulus); rapidly progressing cardiogenic, hepatic, or renal failure; refractory systolic hypotension (systolic blood pressure less than 85 millimeter of mercury \[mmHg\]).
- Time frame
- From randomization to Week 16/Follow up visit (21 weeks)
- Population
- ITT Population
Source ClinicalTrials.gov
Trial
- Title
- Ambrisentan for Inoperable Chronic Thromboembolic Pulmonary Hypertension.
- NCT number
- NCT01884675
- Phases
- PHASE3
- Conditions
- Hypertension
- Interventions
- Ambrisentan 5 mg, Placebo
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2015-12-16
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01884675?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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