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Trial · NCT04622709

Outcomes214

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 5Baseline and study week 5 (5 weeks after study medication start
Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. 36 participants completed the week 5 24-hour urine volume collection. Thus, the analysis population is 36 participants.
percentage of participantsNUMBER
PRIMARYPercentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 12Baseline and study week 12 (12 weeks after study medication start)
Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. 33 participants completed the week 12 24-hour urine volume collection. Thus, the analysis population is 33 participants.
Percentage of participantsNUMBER
PRIMARYPercentage of Participants Who Have a Defined Increase in 24-hour Urine Volume From Baseline to Week 18Baseline and study week 18 (18 weeks after study medication start)
Summarizing outcome events as a single arm (i.e., patients with a baseline 24-hour urine volume ≥200 mL and \< 200 mL as a single group) was pre-specified in the protocol. Out of the 33 participants still enrolled in the study at week 18, 32 completed the week 18 24-hour urine volume collection. Thus, the analysis population is 32 participants.
Percentage of participantsNUMBER
PRIMARYPercentage of Participants With A Serum Potassium <3.2 mEq/L at Week 1Study week 1 (1 week after study medication start)38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants.percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 2Study week 2 (2 weeks after study medication start)37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 3Study week 3 (3 weeks after study medication start)37 participants completed the week 3 blood collection. Thus, the analysis population is 37 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 4Study week 4 (4 weeks after study medication start)37 participants completed the week 4 blood collection. Thus, the analysis population is 37 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 5Study week 5 (5 weeks after study medication start)36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 6Study week 6 (6 weeks after study medication start)36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 9Study week 9 (9 weeks after study medication start)36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 13Study week 13 (13 weeks after study medication start)33 participants completed the week 13 blood collection. Thus, the analysis population is 33 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Potassium <3.2 mEq/L at Week 17Study week 17 (17 weeks after study medication start)33 participants completed the week 17 blood collection. Thus, the analysis population is 33 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 1Study week 1 (1 week after study medication start)38 participants completed the week 1 blood collection. Thus, the analysis population is 38 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 2Study week 2 (2 weeks after study medication start)37 participants completed the week 2 blood collection. Thus, the analysis population is 37 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 3Study week 3 (3 weeks after study medication start)
37 participants completed the week 3 blood collection. However, there was laboratory error and serum magnesium levels were only available for 36 participants. Thus, the analysis population is 36 participants.
Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 4Study week 4 (4 weeks after study medication start)
37 participants completed the week 4 blood collection. However, there was laboratory error and serum magnesium levels were only available for 36 participants. Thus, the analysis population is 36 participants.
Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 5Study week 5 (5 weeks after study medication start)36 participants completed the week 5 blood collection. Thus, the analysis population is 36 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 6Study week 6 (6 weeks after study medication start)36 participants completed the week 6 blood collection. Thus, the analysis population is 36 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 9Study week 9 (9 weeks after study medication start)36 participants completed the week 9 blood collection. Thus, the analysis population is 36 participants.Percentage of participantsNUMBER
PRIMARYPercentage of Participants With a Serum Magnesium <0.8 mEq/L at Week 13Study week 13 (13 weeks after study medication start)33 participants completed the week 13 blood collection. Thus, the analysis population is 33 participants.Percentage of participantsNUMBER

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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