Trial · NCT01028651
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Achieved Hemodynamic Parameters Appropriate for Orthotopic Liver Transplantation Candidacy at Week 24. | 24 Weeks | The primary efficacy endpoint was the number of subjects who achieved a mean pulmonary arterial pressure (mPAP) less than 35 mmHg and a pulmonary vascular resistance (PVR) less than 3 Wood units (WU) at Week 24 in patients with severe portopulmonary hypertension (PoPH). |
| Secondary | Change in Hemodynamic Parameters (Via Right Heart Catheterization [RHC]) at Rest From Baseline to Week 24 | 24 weeks | The change in hemodynamic parameters (including systolic pulmonary arterial pressure \[PAPs\], diastolic pulmonary arterial pressure \[PAPd\], mean pulmonary arterial pressure \[mPAP\], and transpulmonary gradient \[TPG\]) was evaluated at rest from Baseline to Week 24. The median change in hemodynamic parameters from Baseline to Week 24 via right-heart catheterization (RHC) is presented. |
| Secondary | Change in Heart Rate at Rest From Baseline to Week 24 | 24 weeks | The change in heart rate was evaluated at rest from Baseline to Week 24. |
| Secondary | Change in Cardiac Output at Rest From Baseline to Week 24 | 24 weeks | The change in cardiac output was evaluated at rest from Baseline to Week 24. The median change in cardiac output from Baseline to Week 24 is presented. |
| Secondary | Change in Arterial and Venous Oxygen Saturation at Rest From Baseline to Week 24 | 24 weeks | The change in arterial and venous oxygen saturation was evaluated at rest from Baseline to Week 24. |
| Secondary | Change in Pulmonary Vascular Resistance (PVR) at Rest From Baseline to Week 24 | 24 weeks | The change in pulmonary vascular resistance (PVR) was evaluated at rest from Baseline to Week 24. |
| Secondary | Change in 6-minute Walk Distance (6MWD) From Baseline to Weeks 12 and 24. | Baseline and Weeks 12 and 24 | The 6-Minute Walk Test was conducted at Screening, Baseline prior to starting study drug and at least 24 hours after the Screening test, and during the Treatment Phase at Weeks 12 and 24. |
| Secondary | Change in Echocardiogram Parameters (Right Atrium and Right Ventricle Area) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. |
| Secondary | Change in Echocardiogram Parameters (Right Ventricle Diameter) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. |
| Secondary | Change in Echocardiogram Parameters (Right Ventricular Systolic Pressure) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. |
| Secondary | Change in Echocardiogram Parameters (Tricuspid Annular Plane Systolic Excursion) From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | Standard transthoracic echocardiogram with continuous wave Doppler and color flow imaging was completed at Screening. All patients who were enrolled in this study underwent an echocardiogram within 30 days of enrollment as well as repeat echocardiograms on Weeks 12 and 24. |
| Secondary | Change in Quality of Life From Baseline to Weeks 12 and 24 | Baseline and Weeks 12 and 24 | The 36-item Short Form Survey (SF-36) is a health related quality of life instrument, which measures dimensions of physical and social roles and functioning, mental health, vitality, and pain. Items are scored on a 0 to 100 range so that the lowest scores represent the highest disability. The quality of life assessment was conducted at Baseline and Weeks 12 and 24 and the change from Baseline to Weeks 12 and 24 is presented. |
| Secondary | Change in Plasma Brain N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) From Baseline to Weeks 12 and 24 | Baseline to Weeks 12 and 24 | NT-proBNP was assessed at Baseline, Weeks 12 and 24. |
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.
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