Trial · NCT05516498
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in HVPG From Baseline to Week 6, Part A | From Baseline to Week 6 | Absolute change in Hepatic venous pressure gradient from baseline to week 6. |
| Primary | Absolute Change in HVPG From Baseline to Week 6, Part B | From Baseline to Week 6 | Absolute change in Hepatic venous pressure gradient from baseline to week 6. |
| Secondary | HVPG Percentage Change From Baseline to Week 6, Part A | From Baseline to Week 6 | Hepatic venous pressure gradient percentage change from baseline to week 6, Part A. |
| Secondary | HVPG Percentage Change From Baseline to Week 6, Part B | From baseline to week 6 | Hepatic venous pressure gradient percentage change from baseline to week 6, Part B. |
| Secondary | Number of Participants With HVPG Response at Week 6, Part A | From baseline to week 6 | A HVPG responder is defined as a subject having \<10 mmHg at week 6 if baseline HVPG \>=10 or a reduction of \>=1.5 mmHg from baseline to week 6. n: Number of subjects in analysis. N: Number of subjects per treatment group. |
| Secondary | Number of Participants With HVPG Response at Week 6, Part B | From baseline to Week 6 | A HVPG responder in Part B is defined as a subject having at least 20% decrease or a reduction to or below 12 mmHg if baseline HVPG \> 12 mmHG from baseline to Week 6. |
| Secondary | Change in Body Weight (kg) Over Time Course of Study, Part A | From baseline to Week 6 | The analysis is performed using MMRM. The model includes the continuous covariate of the Baseline measurements as the fixed effect covariate and fixed categorical effects of treatment group, visit, and treatmentby-visit interaction. |
| Secondary | Change in Body Weight (kg) Over Time Course of Study, Part B | From baseline to Week 6 and Week 16 | The analysis is performed using MMRM. The model includes the continuous covariate of the Baseline measurements as the fixed effect covariate and fixed categorical effects of treatment group, visit, and treatmentby-visit interaction. |
| Secondary | Change in Total Dosage of Loop-diuretic Equivalents Use From Baseline to Week 6, Part A | From baseline to Week 6 | Change in total dosage of loop-diuretic equivalents use from baseline to Week 6, Part A. A loop-diuretic equivalent is based on 40 mg furosemide = 1 mg bumetanide = 20 mg torsemide = 50 mg ethacrynic acid. |
| Secondary | Change in Total Dosage of Loop-diuretic Equivalents Use From Baseline to Week 6 and Week 16, Part B | From Baseline to Week 6 and Week 16 | Change in total dosage of loop-diuretic equivalents use from baseline to Week 6, Part B. A loop-diuretic equivalent is based on 40 mg furosemide = 1 mg bumetanide = 20 mg torsemide = 50 mg ethacrynic acid. |
| Secondary | Change in Total Body Water From Baseline to Week 6, Part A | From Baseline to Week 6 | Change in total body water from baseline to Week 6, Part A. The analysis is performed using MMRM. |
| Secondary | Change in Total Body Water From Baseline to Week 6 and Week 16, Part B | From Baseline to Week 6 and Week 16 | Change in total body water from baseline to Week 6 and Week 16, Part B. The analysis is performed using MMRM. |
| Secondary | Change in Extracellular Water From Baseline to Week 6, Part A | From baseline to Week 6 | Change in extracellular water from baseline to Week 6, Part A. The analysis is performed using MMRM. Bioimpedance spectroscopy (BIS) was performed at the study centre to monitor body water volumes and body fat mass. |
| Secondary | Change in Extracellular Water From Baseline to Week 6 and Week 16, Part B | From Baseline to Week 6 and to Week 16 | Change in extracellular water from baseline to Week 6 and Week 16, Part B. The analysis is performed using MMRM. Bioimpedance spectroscopy (BIS) was performed at the study centre to monitor body water volumes and body fat mass. |
| Secondary | Change in Intracellular Water From Baseline to Week 6, Part A | From Baseline to Week 6 | Change in intracellular water from Baseline to Week 6, Part A. The analysis is performed using MMRM. Bioimpedance spectroscopy (BIS) was performed at the study centre to monitor body water volumes and body fat mass. |
| Secondary | Change in Intracellular Water From Baseline to Week 6 and Week 16, Part B | From Baseline to Week 6 and Week 16 | Change in intracellular water from Baseline to Week 6 and Week 16, Part B. The analysis is performed using MMRM. Bioimpedance spectroscopy (BIS) was performed at the study centre to monitor body water volumes and body fat mass. |
| Secondary | Change in Total Body Fat Mass From Baseline to Week 6, Part A | From baseline to Week 6 | Change in total body fat mass from Baseline to Week 6, Part A. The analysis is performed using MMRM. Bioimpedance spectroscopy (BIS) was performed at the study centre to monitor body water volumes and body fat mass. |
| Secondary | Change in Total Body Fat Mass From Baseline to Week 6 and Week 16, Part B | From Baseline to Week 6 and Week 16 | Change in total body fat mass from Baseline to Week 6 and Week 16, Part B. The analysis is performed using MMRM. Bioimpedance spectroscopy (BIS) was performed at the study centre to monitor body water volumes and body fat mass. |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 6, Part A | From Baseline to Week 6 | Change in systolic blood pressure from baseline to Week 6, Part A. The analysis is performed using MMRM. |
| Secondary | Change in Systolic Blood Pressure From Baseline to Week 6 and Week 16, Part B | From baseline to Week 6 and Week 16 | Change in systolic blood pressure from baseline to Week 6 and Week 16, Part B. The analysis is performed using MMRM. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT05516498/registered