Trial · NCT03172702
Outcomes17
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 safety analysis set for the MP (SAF-MP) included all patients treated with at least 1 dose of MP ZS and who had any MP safety data. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Who Were Normokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The full analysis set for the MP (FAS-MP) included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| 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 FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Were Hypokalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Patients Who Were Hyperkalemic in the MP | MP Day 1 to End of Study visit (up to 12 months). | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| 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 FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| 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 FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| SECONDARY | Mean Number of Normokalemic Days During the MP | MP Day 1 to Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Days | MEAN |
| 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 FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| SECONDARY | Change From CP Baseline in S-Aldosterone Levels Over the MP | CP Day 1, MP Day 166 and MP Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Picomole per liter (pmol/L) | MEAN |
| SECONDARY | Percentage of Patients With Normal S-Aldosterone Levels Over the MP | CP Day 1, MP Day 166 and MP Day 362. | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| 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 FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | mmol/L | MEAN |
| 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 FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Percentage of patients | NUMBER |
| 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). | The FAS-MP included all patients who received at least 1 dose of ZS during the MP and who had any post-baseline MP S-K values. | Scale score | MEAN |
| SECONDARY | Mean Change From CP Baseline in the Mean S-K Levels in the CP | CP Day 1 to Day 3. | The CP full analysis set (FAS-CP) included all patients who received at least 1 dose of ZS during the CP and who had any post-baseline CP S-K values. | mmol/L | MEAN |
| SECONDARY | Percentage of Patients Who Were Normokalemic in the CP | CP Day 1 to Day 3. | The FAS-CP included all patients who received at least 1 dose of ZS during the CP and who had any post-baseline CP S-K values. | Percentage of patients | NUMBER |
| 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 SAF-CP included all patients treated with at least 1 dose of CP ZS and who had any CP safety data. | Participants | COUNT_OF_PARTICIPANTS |
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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GET https://conductscience.org/api/trials/v1/NCT03172702/outcomes