Trial · NCT04518306
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 | At Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 | At Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 4 | At Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 4 | Randomization to Week 4 | Analysis was performed on randomized set (All participants who have been randomized). Participants were analyzed in the treatment group to which they have been randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants Discontinued Trial Medication Due to Adverse Event (AE) or a Serious Adverse Event (SAE) From Randomization to Week 4 | Randomization to Week 4 | Analysis was done on safety population. The Safety Set is defined as all participants who took at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety endpoints, participants were analyzed in the treatment group they actually received. One participant each from Triple ½ (GMRx2) and Placebo group did not receive randomly assigned treatment during Randomization to Week 4 period. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With an Serious Adverse Event (SAE) From Randomization to Week 4 | Randomization to Week 4 | Analysis was done on safety population. The Safety Set is defined as all participants who took at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety endpoints, participants were analyzed in the treatment group they actually received. One participant each from Triple ½ (GMRx2) and Placebo group did not receive randomly assigned treatment during Randomization to Week 4 period. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Symptomatic Hypotension From Randomization to Week 4 | Randomization to Week 4 | Analysis was done on safety population. The Safety Set is defined as all participants who took at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety endpoints, participants were analyzed in the treatment group they actually received. One participant each from Triple ½ (GMRx2) and Placebo group did not receive randomly assigned treatment during Randomization to Week 4 period. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 4 | At Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 4 | At Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | The Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 4 | At Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 4 | At Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With eGFR Drop of Over 30% From Randomization to Week 4 | Randomization to Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Serum Sodium <135mmol/l or >145 mmol/l, and/or Serum Potassium <3.5 mmol/l or >5.5mmol/l at Week 4 | At Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Postural Hypotension at Week 4 | At Week 4 | The analysis of binary secondary safety endpoints was performed on the Safety Analysis Set, limited to those participants who were randomized. | 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.
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