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Trial · NCT04518293

Registered outcomes40

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
OtherPercentage of Participants With a Serious Adverse Event (SAE) From Randomization to Week 12At Week 12The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 12.
OtherPercentage of Participants With Serious Adverse Event (SAE) From Randomization to Week 6Week 6The secondary safety outcome is the proportion of participants with at least one SAE from randomization to follow-up at Week 6.
OtherPercentage of Participants With Symptomatic Hypotension From Randomization to Week 12Week 12The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 12.
OtherPercentage of Participants With Symptomatic Hypotension From Randomization to Week 6Week 6The secondary safety outcome is the proportion of participants who experienced at least one symptomatic hypotension episode from randomization to follow-up at Week 6.
OtherPercentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 12Week 12The secondary safety outcome is the proportion of participants with serum sodium \<135 mmol/L at follow-up Week 12.
OtherPercentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 6Week 6The secondary safety outcome is the proportion of participants with serum sodium \<135 mmol/L at follow-up Week 6.
OtherPercentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 12Week 12The secondary safety outcome is the proportion of participants with serum sodium \>145 mmol/L at follow-up Week 12.
OtherPercentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 6Week 6The secondary safety outcome is the proportion of participants with serum sodium \>145 mmol/L at follow-up Week 6.
OtherPercentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 12Week 12The secondary safety outcome is the proportion of participants with serum potassium concentration \<3.5 mmol/L at follow-up Week 12.
OtherPercentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 6Week 6The secondary safety outcome is the proportion of participants with serum potassium concentration below 3.5 mmol/l at follow-up Week 6.
OtherPercentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 12Week 12The secondary safety outcome is proportion of participants with serum potassium concentration \>5.5 mmol/l at follow-up Week 12.
OtherPercentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 6Week 6The secondary safety outcome is proportion of participants with serum potassium concentration \>5.5 mmol/L at follow-up Week 6.
OtherPercentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 12Week 12The secondary safety outcome was the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 12.
OtherPercentage of Participants With Estimated Glomerular Filtration Rate (eGFR) Drop of Over 30% From Randomization to Week 6Week 6The secondary safety outcome is the proportion of participants with an eGFR drop of over 30% from randomization to follow-up at Week 6.
OtherPercentage of Participants With Serum Sodium <135mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5mmol/L at Follow-up Week 12Week 12The secondary safety outcome is the proportion of participants with serum sodium \<135mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5mmol/L at follow-up Week 12.
OtherPercentage of Participants With Serum Sodium <135 mmol/L or >145 mmol/L, and/or Serum Potassium <3.5 mmol/L or >5.5 mmol/L at Week 6Week 6The secondary safety outcome is proportion of participants with serum sodium \<135 mmol/L or \>145 mmol/L, and/or serum potassium \<3.5 mmol/L or \>5.5 mmol/L at follow-up Week 6.
OtherPercentage of Participants With Orthostatic Hypotension at Week 6Week 6The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 6.
OtherPercentage of Participants With Orthostatic Hypotension at Week 12Week 12The secondary safety outcome is the proportion of participants with orthostatic hypotension at follow-up Week 12.
OtherPercentage of Participants With Orthostatic Hypertension at Week 6Week 6The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 6.
OtherPercentage of Participants With Orthostatic Hypertension at Week 12Week 12The secondary safety outcome is the proportion of participants with orthostatic hypertension at follow-up Week 12.

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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