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Trial · NCT06269484

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY
Cumulative Number of Subjects With Any of the Components of the Composite Endpoint: >2kg Increase in Body Weight (Office-based), >2 L Increase in Total Body Water, Increase in 2 or More Loop-diuretic Equivalents, Fluid Retention Adverse Event (AE)
baseline to Week 6All randomised subjects who received at least one dose of treatment are included in the analysis.~For intercurrent events treatment policy strategy was used. No imputation was performed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline in Body Weightat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.kgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Body Fat Massat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.kgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Total Body Waterat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.LLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Extracellular Water Volumeat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.LLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Intracellular Water Volumeat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.LLEAST_SQUARES_MEAN
SECONDARYChange in Body Weight (kg) Over Time Course of Studyat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.kgLEAST_SQUARES_MEAN
SECONDARYChange in Total Dosage of Loop-diuretic Equivalents Useat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.Loop-diuretic *mg* equivalentLEAST_SQUARES_MEAN
SECONDARY
Cumulative Number of Subjects With Either of the Two Components of This Composite: 1. >3 L Increase in Total Body Water Volume From Baseline to Week 6 2. Increase in 3 or More Loop-diuretics Equivalents Use
from baseline to Week 6All randomised subjects who received at least one dose of treatment are included in the analysis.~For intercurrent events treatment policy strategy was used. No imputation was performed.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYAbsolute Change in Systolic Blood Pressureat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.mmHgLEAST_SQUARES_MEAN
SECONDARYAbsolute Change in Diastolic Blood Pressureat Week 6All randomised subjects who received at least one dose of treatment are included in the analysis. For intercurrent events treatment policy strategy was used. No imputation was performed.mmHgLEAST_SQUARES_MEAN

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.

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