Trial · NCT02088073
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Serum Potassium Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT Population). | 22 Days; Maintenance Phase Days 8 - 29, inclusive. | The least squares means (LSMeans) are dervied from a mixed effects model of serial log transformed S-K values between Days 8 and 29 with patients as a random effect and the following fixed effects terms: MP treatment group; AP baseline eGFR; AP and MP baseline S-K levels, age categories (\<55, 55-64, \>= 65 years); and binary indicators for RAAS inhibitors use, CKD, CHF, and DM. The LSmeans estimate obtained from the above model is back-transformed and presented as the lsmeans of all available S-K values during the Maintenance phase study Days 8 to 29. |
| Secondary | The Number of Normokalemic Days Between Maintenance Phase Study Days 8 to 29, Inclusive (MP-ITT). | 22 days; Maintenance Phase Day 8 - 29, inclusive. | The number of normokalemic days during the Maintenance Phase Study Days 8 to 29 is calculated assuming that the interval between assessments is normokalemic only if both the beginning and end assessments for that time interval display normal S-K values (i.e. 3.5 - 5.0 mmol/L) |
| Secondary | Mean Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit . | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | |
| Secondary | Mean Percent Change in S-K Levels From Acute Phase Baseline to Maintenance Phase Study Day 2 to Day 29/Exit, Inclusive . | Acute Phase baseline to Maintenance Phase Study Day 2 to Day 29/Exit, inclusive. | |
| Secondary | Mean Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | |
| Secondary | Mean Percent Change in S-K Levels From Maintenance Phase Baseline to Maintenance Phase Day 2 to Day 29/Exit. | Maintenance phase baseline to Maintenance Phase Study Day 29/Exit, inclusive. | |
| Secondary | Median Time to Hyperkalemia (S-K ≥ 5.1mmol/L) | Maintenance Phase baseline to maintenance Phase Study Day 29/Exit. | |
| Secondary | Mean S-K Intra-subject Standard Deviation Calculated Among Subjects With ≥ 2 Values on or After Maintenance Phase Study Day 8 | 22 days; Maintenance Phase Day 8 - 29 | |
| Secondary | Proportion of Subjects Who Remained Normokalemic During Maintenance Phase | Maintenance Phase Study Days 1, 2, 5, 8, 12, 15, 19, 22, 26, 29, and 35, inclusive. | |
| Secondary | Median Time to Relapse in S-K Values | Maintenance phase Study Day 1 to Study Day 29/Exit. | Median time to relapse in S-K values (return to original Acute Phase S-K baseline value) |
| Secondary | Exponential Rate of Change in S-K Values During the Acute Phase at 24 Hours and 48 Hours of Study Drug Treatment. | Acute Phase 24 hours and Acute Phase 48 hours. | |
| Secondary | Mean Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase. | All measured time intervals post dose during the Acute Phase. | |
| Secondary | Mean Percent Change From Baseline in S-K Values (Blood) at All Measured Time Intervals Post Dose Acute Phase. | All measured time intervals post dose during the Acute Phase. | |
| Secondary | Proportion of Subjects Who Achieve Normokalemia During the Acute Phase at 24 and 48 Hours After Start of Dosing | Through 48 hours acute phase | |
| Secondary | Median Time to Normalization (3.50-5.0 mmol/L) in S-K Levels in the 48 Hours of Initial Treatment | Through 48 hours acute phase |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02088073/registered