Trial · NCT03172702
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Who Experienced Adverse Events (AEs) in the MP | First MP dose up to 1 day (2 days for QOD regimen) after last MP dose. | The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension. |
| Secondary | Percentage of Patients Who Were Normokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients who were normokalemic at each study visit in the MP is presented. Normokalemia was defined as a serum potassium (S-K) level of ≥ 3.5 and ≤ 5.0 mmol/L. The percentage of patients who were normokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days. |
| Secondary | Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP | MP Day 2 to Day 362. | The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented. |
| Secondary | Percentage of Patients Who Were Hypokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients who were hypokalemic at each study visit in the MP is presented. Hypokalemia was defined as a S-K level of \< 3.5 mmol/L. The percentage of patients who were hypokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days. |
| Secondary | Percentage of Patients Who Were Hyperkalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients who were hyperkalemic at each study visit in the MP is presented. Hyperkalemia was defined as a S-K level of \>5.0 mmol/L. The percentage of patients who were hyperkalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days. |
| Secondary | Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP | CP Day 1 to MP Day 362. | The mean changes from the CP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1. |
| Secondary | Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP | MP Day 1 to Day 362. | The mean changes from the MP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the MP was defined as the measurement taken in the morning of the day of entering the MP (MP Day 1). |
| Secondary | Mean Number of Normokalemic Days During the MP | MP Day 1 to Day 362. | The number of normokalemic days during the MP was calculated assuming the time interval between assessments was normokalemic if both the beginning and end assessments for that time interval displayed normal S-K values. If an intermediate scheduled assessment time point was missing, then the scheduled assessment was regarded as not normokalemic. The mean number of normokalemic days for a patient in the MP is presented. |
| Secondary | Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study | MP Day 1 to End of Study visit (up to 12 months). | The mean change in the S-K level from the last on-treatment MP visit to the End of Study is presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose. |
| Secondary | Change From CP Baseline in S-Aldosterone Levels Over the MP | CP Day 1, MP Day 166 and MP Day 362. | The mean change from CP baseline to MP Day 166 and MP Day 362 in S-aldosterone levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. |
| Secondary | Percentage of Patients With Normal S-Aldosterone Levels Over the MP | CP Day 1, MP Day 166 and MP Day 362. | The percentage of patients with normal S-aldosterone levels up to Day 362 of the MP is presented. The normal range for S-aldosterone was 0 - 776.72 pmol/L. In addition, the percentage of patients with normal S-aldosterone levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. |
| Secondary | Change From CP Baseline in S-Bicarbonate Levels Over the MP | CP Day 1, and MP Day 1 to End of Study visit (up to 12 months). | The mean change from CP baseline to timepoints in the MP in S-bicarbonate levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose. |
| Secondary | Percentage of Patients With Normal S-Bicarbonate Levels Over the MP | CP Day 1 and MP Day 1 to End of Study visit (up to 12 months). | The percentage of patients with normal S-bicarbonate levels up to the End of Study visit in the MP is presented. The normal range for S-bicarbonate was 17 - 32 mmol/L. In addition, the percentage of patients with normal S-bicarbonate levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose. |
| Secondary | Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores | CP Day 1 (baseline) and MP Day 362 (post-baseline). | Patients completed the SF-36 v2 questionnaire on Day 1 of the CP and on Day 362 of the MP. The responses to the items assessing the physical and mental health of the patients determined the PCS and MCS based on a standard algorithm. The PCS and MCS scores ranged from 0 (worst possible health state) to 100 (best possible health state). The mean PCS and MCS are presented for the baseline and post-baseline assessments. |
| Secondary | Mean Change From CP Baseline in the Mean S-K Levels in the CP | CP Day 1 to Day 3. | The mean change from the CP baseline at 24, 48 and 72 hours in the CP is presented. The mean change from baseline to the last on-treatment CP value is also presented. The last on-treatment value was defined as the last measurement taken with 1 day (2 days if on the QOD regimen) after the last ZS dose. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1. |
| Secondary | Percentage of Patients Who Were Normokalemic in the CP | CP Day 1 to Day 3. | The percentage of patients who were normokalemic at 24, 48 and 72 hours in the CP is presented. Normokalemia was defined as a S-K level of ≥ 3.5 and ≤ 5.0 mmol/L. |
| Secondary | Number of Patients Who Experienced AEs in the CP | Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier. | The number of patients who experienced any AE, including SAEs, those which had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the CP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension. |
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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