Trial · NCT01223352
Results by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
1 to 20 of 38
Download this page as JSON| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan | Bosentan 2 mg/kg t.i.d. (PK Set) | 7275.1 | 95% Confidence Interval 5468.2 to 9679.0 | h*ng/mL | |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan | Bosentan 2 mg/kg b.i.d. (PK Set) | 8535.4 | 95% Confidence Interval 6936.0 to 10503.7 | h*ng/mL | |
| Dose-corrected Maximum Plasma Concentration [Cmaxc] of Bosentan | Bosentan 2 mg/kg t.i.d. (PK Set) | 527.9 | 95% Confidence Interval 386.0 to 721.9 | ng/mL | |
| Dose-corrected Maximum Plasma Concentration [Cmaxc] of Bosentan | Bosentan 2 mg/kg b.i.d. (PK Set) | 742.8 | 95% Confidence Interval 572.8 to 963.2 | ng/mL | |
| Time to Reach Cmax [Tmax] of Bosentan | Bosentan 2 mg/kg t.i.d. (PK Set) | 3 | Full Range 1 to 8 | hours | |
| Time to Reach Cmax [Tmax] of Bosentan | Bosentan 2 mg/kg b.i.d. (PK Set) | 3 | Full Range 0 to 7.5 | hours | |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056) | Bosentan 2 mg/kg t.i.d. (PK Set) | AUC(0-24C) for Ro 478634 | 173.2 | 95% Confidence Interval 126.2 to 237.6 | h*ng/mL |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056) | Bosentan 2 mg/kg b.i.d. (PK Set) | AUC(0-24C) for Ro 478634 | 200.4 | 95% Confidence Interval 152.2 to 263.9 | h*ng/mL |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056) | Bosentan 2 mg/kg t.i.d. (PK Set) | AUC(0-24C) for Ro 485033 | 968.8 | 95% Confidence Interval 723.3 to 1297.7 | h*ng/mL |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056) | Bosentan 2 mg/kg b.i.d. (PK Set) | AUC(0-24C) for Ro 485033 | 1352.5 | 95% Confidence Interval 1073.4 to 1704.0 | h*ng/mL |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056) | Bosentan 2 mg/kg t.i.d. (PK Set) | AUC(0-24C) for Ro 641056 | 716.2 | 95% Confidence Interval 543.5 to 943.8 | h*ng/mL |
| Dose-corrected Daily Exposure [AUC(0-24c)] to Bosentan Metabolites (Ro 478634, Ro 485033, Ro 641056) | Bosentan 2 mg/kg b.i.d. (PK Set) | AUC(0-24C) for Ro 641056 | 1014.1 | 95% Confidence Interval 801.2 to 1283.6 | h*ng/mL |
| Change From Baseline in WHO Functional Class at End of Study | Bosentan 2 mg/kg t.i.d. | Worsened WHO FC | 1 | Participants | |
| Change From Baseline in WHO Functional Class at End of Study | Bosentan 2 mg/kg b.i.d | Worsened WHO FC | 1 | Participants | |
| Change From Baseline in WHO Functional Class at End of Study | Bosentan 2 mg/kg t.i.d. | Unchanged WHO FC | 27 | Participants | |
| Change From Baseline in WHO Functional Class at End of Study | Bosentan 2 mg/kg b.i.d | Unchanged WHO FC | 25 | Participants | |
| Change From Baseline in WHO Functional Class at End of Study | Bosentan 2 mg/kg t.i.d. | Improved WHO FC | 3 | Participants | |
| Change From Baseline in WHO Functional Class at End of Study | Bosentan 2 mg/kg b.i.d | Improved WHO FC | 7 | Participants | |
| Change From Baseline in Global Clincial Impression Scale (GCIS) at End of Study | Bosentan 2 mg/kg t.i.d. | Worsened as per physician evaluation | 2 | Participants | |
| Change From Baseline in Global Clincial Impression Scale (GCIS) at End of Study | Bosentan 2 mg/kg b.i.d. | Worsened as per physician evaluation | 2 | Participants |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT01223352/results