Comparison · NCT01894022-05083de5
Previous Ambrisentan vs Previous Placebo: Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit
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. Previous Ambrisentan vs Previous Placebo: Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit. Trial comparisons, record NCT01894022-05083de5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01894022-05083de5
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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 | 0.278 | wilson | |
| Risk in group 2 | 0.111 | 0.0199 | 0.435 | wilson | |
| Risk difference, group 1 minus group 2 | -0.111 | -0.435 | 0.181 | 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, for one fewer participant with the outcome on Previous Ambrisentan than on Previous Placebo | 9 | 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 | Previous Ambrisentan | Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD. | 0 | 10 | OG001 |
| Group 2 | Previous Placebo | Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD. | 1 | 9 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Creatinine Values of Potential Clinical Concern at Any Time Post Entry Visit
- Description
Blood samples were collected at Entry visit of the extension study, Month 1, Month 3, Month 6, Month 9, Month 12, Month 15, and end of study plus any unscheduled lab tests for creatinine. A creatinine value of potential clinical concern high was defined as \>=176.8 micromoles per Liter. Participants with both normal and high values were counted once under their worst case (high). Participant's final visit in study AMB115811 was used as the entry visit of this open-label extension study.
- Time frame
- Entry visit of the extension study; Months 1, 3, 6, 9, 12, 15; and End of Study plus any unscheduled lab tests (assessed up to approximately 16 months)
- Population
- Safety (Extension) Population
Source ClinicalTrials.gov
Trial
- Title
- A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
- NCT number
- NCT01894022
- Phases
- PHASE3
- Conditions
- Hypertension
- Interventions
- Ambrisentan 5 mg
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2017-06-08
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01894022?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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