Trial · NCT02875834
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Least Square Mean S-K Level on Days 8-29 | Through 28-day randomized treatment study phase day 8-29. | Comparison between placebo and the active ZS treatment groups (each dose group will be sequentially compared with placebo, starting with the highest and ending with the lowest dose) with regard to the mean S-K level during the 28-day randomized treatment study phase Days 8-29. The results in the table below are presented for RTP. |
| Secondary | Proportion of Patients Achieving Normokalemia | Through 48-hour initial phase. | Proportion of patients who achieve normokalemia during the initial phase at 24 and 48 hours. The results in the table below are presented for OLP. (h=hours). |
| Secondary | Exponential Rate of Change in S-K Levels | Through 48-hour initial phase. | Exponential rate of change in S-K levels (blood) during the 48-hour open-label initial phase. The results in the table below are presented for OLP. |
| Secondary | Absolute Change From Baseline in S-K Levels | Through 48-hour initial phase. | Absolute change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP. |
| Secondary | Percentage Change From Baseline in S-K Levels | Through 48-hour initial phase. | Percentage change from baseline in S-K levels at all measured time intervals. The results in the table below are presented for OLP. |
| Secondary | Proportion of Patients Remaining Normokalemic | Through 28-day randomized treatment study phase day 8-29. | The proportion of patients who remain normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at the end of the 28-day randomized treatment study phase and during the 28-day randomized treatment study phase. The results in the table below are presented for RTP. |
| Secondary | Proportion of Normokalemic Patients at Day 1 Through Day 29/Exit | Through 28-day randomized treatment phase. | The proportion of patients who are normokalemic (as defined by S-K between 3.5-5.0 mmol/l, inclusive) at Day 1 through Day 29/Exit in randomization phase. The results in the table below are presented for RTP. |
| Secondary | Days Patients Remain Normokalemic | Through 28-day randomized treatment phase. | The number of days patients remain normokalemic during the 28-day randomized treatment study phase. The results in the table below are presented for RTP. |
| Secondary | Mean Change in S-K Levels | Through 28-day randomized treatment phase. | The mean change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP. |
| Secondary | Mean Percentage Change in S-K Levels | Through 28-day randomized treatment phase. | The mean percentage change in S-K levels evaluated relative to both baselines. The results in the table below are presented for RTP. |
| Secondary | Number of Hyperkalemic Patients | Through 28-day randomized treatment phase. | The results represent number of hyperkalemic patients during the 28-day randomized treatment study phase. The results in the table below are presented for RTP. |
| Secondary | Mean Changes in S-Aldosterone and P Renin Levels | Through 28-day randomized treatment phase. | The mean changes from OLP baseline in S-Aldosterone and P-Renin levels. The results in the table below are presented for RTP. |
| Secondary | Patient Reported Health State (EQ-5D) Questionnaire | Through study completion, an average of 37 days. | Evaluate health state of patients using EQ-5D questionnaire. This scale is numbered from 0 to 100. 0 means the worst health you can imagine. 100 means the best health you can imagine. The results in the table below are presented for RTP. |
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.
For software
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