A Multicentre, Randomised, Double-blind, Placebo-controlled, Phase IIb Study to Evaluate the Safety of Zibotentan/Dapagliflozin in Combination Compared to Zibotentan Monotherapy as well as Zibotentan/Dapagliflozin and Zibotentan Monotherapy Compared to Placebo in Participants with Cirrhosis

Conditions

Cirrhosis of the liver is a condition in which the liver is scarred and damaged

Brief summary

Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 kg increase in body weight (office-based), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 L increase in total body water, Occurrence of any of the following components of this composite endpoint from baseline to Week 6: Increase in 2 or more loop-diuretic equivalents, Occurrence of any of the following components of this composite endpoint from baseline to Week 6:Fluid retention adverse event (AE), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 kg increase in body weight (office-based), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 L increase in total body water, Occurrence of any of the following components of this composite endpoint from baseline to Week 6: Increase in 2 or more loop-diuretic equivalents, Occurrence of any of the following components of this composite endpoint from baseline to Week 6:Fluid retention adverse event (AE), Change in body weight (kg) over time course of study (home-based monitoring)., Change from baseline in body weight, total body water, extracellular and intracellular water volumes, and body fat mass at Week 6 (office-based monitoring)., Change in total dosage of loop-diuretic equivalents use from baseline to Week 6., Occurrence of either of the two components of this composite: > 3 L increase in total body water volume from baseline to Week 6., Occurrence of either of the two components of this composite: Increase in 3 or more loop-diuretic equivalents use from baseline to Week 6., Absolute change in systolic and diastolic blood pressure from baseline to Week 6.

Detailed description

AEs, SAEs, and DAEs, AESIs (new or worsening HF; other signs of fluid retention; orthostatic hypotension; UTI; GI; AKI), Vital signs, Safety laboratory tests, ECG assessments

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGZibotentan

DRUGDAPAGLIFLOZIN

DRUGZibotentan placebo

DRUGDapagliflozin placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 kg increase in body weight (office-based), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 L increase in total body water, Occurrence of any of the following components of this composite endpoint from baseline to Week 6: Increase in 2 or more loop-diuretic equivalents, Occurrence of any of the following components of this composite endpoint from baseline to Week 6:Fluid retention adverse event (AE), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 kg increase in body weight (office-based), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 L increase in total body water, Occurrence of any of the following components of this composite endpoint from baseline to Week 6: Increase in 2 or more loop-diuretic equivalents, Occurrence of a	—

Measure

Time frame

Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 kg increase in body weight (office-based), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 L increase in total body water, Occurrence of any of the following components of this composite endpoint from baseline to Week 6: Increase in 2 or more loop-diuretic equivalents, Occurrence of any of the following components of this composite endpoint from baseline to Week 6:Fluid retention adverse event (AE), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 kg increase in body weight (office-based), Occurrence of any of the following components of this composite endpoint from baseline to Week 6: > 2 L increase in total body water, Occurrence of any of the following components of this composite endpoint from baseline to Week 6: Increase in 2 or more loop-diuretic equivalents, Occurrence of a

—

Secondary

Measure	Time frame
AEs, SAEs, and DAEs, AESIs (new or worsening HF; other signs of fluid retention; orthostatic hypotension; UTI; GI; AKI), Vital signs, Safety laboratory tests, ECG assessments	—

Countries

Belgium, Czechia, Germany, Italy, Poland, Slovakia

Outcome results

None listed