| Primary | Number of Participants Remaining on Spironolactone at Week 12 | The proportion of subjects remaining on spironolactone at Week 12 will be compared between treatment groups (spironolactone/patiromer versus spironolactone/placebo). Subjects who discontinued from the study early or discontinued study spironolactone prior to Week 12, for any reason, were considered as not having remained on spironolactone until Week 12. | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. | Posted | | Count of Participants | | Participants | | At week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| A sample size of 280 subjects has 90% power to detect a difference between treatment groups of 20% or more in the proportion of subjects remaining on spironolactone at Week 12, at α = 0.05. | Cochran-Mantel-Haenszel | | <0.0001 | α-level 0.05. Stratified by baseline potassium category (4.3-<4.7 mEq/L or 4.7-5.1 mEq/L) and history of Type 1 or Type 2 diabetes mellitus (Yes or No) as randomized | | | | | | | | | | | | | Superiority | | |
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| Secondary | Change in AOBP SBP From Baseline to Week 12 or Last Available AOBP SBP Prior to Addition of Any New BP Medications or Increase From Any Baseline BP Medications | AOBP: Automated Office Blood Pressure SBP: Systolic Blood Pressure BP: Blood Pressure | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. | Posted | | Mean | Standard Deviation | mmHg | | From baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Change in AOBP SBP From Baseline to Week 12 Regardless of Increase in Antihypertensives | AOBP SBP: Automated Office Systolic Blood Pressure | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. | Posted | | Mean | Standard Deviation | mmHg | | From baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Central Serum Potassium Change From Baseline to Week 12 by Baseline Serum Potassium Category | The two baseline potassium subgroups, 4.3-<4.7 mEq/L versus 4.7-5.1 mEq/L, are based on central laboratory data. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP <4.3 mEq/L or >5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period. | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. Table depicts those participants with values at Baseline and Week 12. Those participants with no available results at W12 were not included in the table below. | Posted | | Mean | Standard Deviation | mEq/L | | From baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Participants With Central Serum Potassium <5.5 mEq/L Over Time | Baseline Central Serum Potassium: BCSP. The symbols > and ≤ included in the row titles are used to indicate the time interval [">Week1 and ≤Week2" meaning from day 8 until day 14 (included)]. If a participant's serum potassium result at baseline was not in one of the two subgroups reported below, the participant's potassium stratum at randomization was used. Therefore, participants with BCSP <4.3 mEq/L or >5.1 mEq/L at baseline (Day 0) have been classified according to their serum potassium values at the Screening period. | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. Table depicts those participants with values at mentioned time frame. Those participants with no available results were not included in the table below. | Posted | | Count of Participants | | Participants | | From baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Participants Having Spironolactone Titrations Over Time | The titration was performed according to the following criteria: Spironolactone was increased in cases of hypertension, decreased or stopped in cases of hypotension and maintained if the blood pressure results were adequate The symbols > and ≤ included in the row titles are used to indicate the time interval [">Week1 and ≤Week2" meaning from day 8 until day 14 (included)]. | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. Reported results only include the number of participants having spironolactone titrations over time according to the classification defined below. | Posted | | Count of Participants | | Participants | | From baseline to Week 12 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Number of Participants by Spironolactone Dose Prescribed at Each Visit | QD: Once daily QOD: Once every other day | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. | Posted | | Count of Participants | | Participants | | From baseline to Week 10 | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Shifts in Selected Laboratory Tests From Baseline to End of Treatment | The end of treatment value is defined as the last non-missing value on or prior to the last spironolactone dose date (from End of Treatment - Case report form) + 3 days LLN=Lower limit of the normal range. ULN=Upper limit of the normal range. EoT=End of Treatment | | Posted | | Number | | participants | | From Baseline to End of Treatment, up to 12 weeks. | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Other Pre-specified | Spironolactone Dose Level at End of 12 Weeks of Study Treatment | Row title: Participants not completing 12W of study treatment: Participants who had not completed 12 weeks of study treatment. | Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. | Posted | | Count of Participants | | Participants | | 12 Weeks of Study Treatment | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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| Post-Hoc | Number of Participants Requiring Additional New Antihypertensive Medications or Increases to Baseline Antihypertensive Medications | Row Titles:
- AM: Antihypertensive Medication(s)
- New AM: Participants who required additional new antihypertensive medication(s)
- Increases to baseline AM: Participants who required increases to baseline antihypertensive medication(s)
- Addition new (or increase) AM: Participants who required addition of new antihypertensive medication(s) and/or increases to baseline antihypertensive medications
- At any time during the study: During study
- While on study medication: On medication
| Intent-to-Treat population (ITT): The ITT population included all participants who were randomized and who took at least 1 dose of spironolactone and at least 1 dose of patiromer/placebo. | Posted | | Number | | participants | | From baseline to Week 12/Early Termination visit | | | | ID | Title | Description |
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| OG000 | Group 1 - Patiromer | Spironolactone + blinded patiromer Patiromer: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally | | OG001 | Group 2 - Placebo | Spironolactone + blinded placebo Placebo: 2 packets/day starting dose, administered orally Spironolactone: 25 mg tablet/day starting dose, administered orally |
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