Trial · NCT04518306
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Difference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. |
| Secondary | Difference in Change in Clinic Seated Mean Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid SBP values (ie. SBP\>60 mmHg and \<250 mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. |
| Secondary | Difference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP\>40mmHg and \<150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. |
| Secondary | Percentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and DBP <90 mmHg at Week 4 | At Week 4 | The percentage of participants achieving averaged clinic SBP \<140 and DBP \<90 mmHg at Week 4 was evaluated. |
| 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 | The percentage of participants achieving averaged clinic SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated. Participants were analyzed in the treatment group to which they have been randomized. |
| Secondary | Difference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Each blood pressure (BP) measurement consisted of valid DBP values (ie. DBP\>40mmHg and \<150mmHg). BP values were summarized using descriptive statistics, including actual values and changes from randomization to Week 4, by timepoint and treatment groups. To evaluate the difference in change, least squares mean change value is reported. |
| Secondary | Difference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 4 | Randomization to Week 4 | Difference in change in trough home SBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication. |
| Secondary | Difference in Change in Trough Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 4 | Randomization to Week 4 | Difference in change in trough home DBP for GMRx2 vs placebo was evaluated at Week 4. Trough values were measured before morning dose of the study medication. To evaluate the difference in change, least squares mean change value is reported. |
| 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 | The percentage of participants achieving home seated mean SBP \<135 and DBP \<85 mmHg at Week 4 was evaluated |
| 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 | The percentage of participants achieving averaged home seated mean SBP \<130 and DBP \<80 mmHg at Week 4 was evaluated |
| Other | 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 | The primary safety outcome is percentage of participants discontinued trial medication due to an Adverse Event (AE) or a Serious Adverse Event (SAE) from randomization to Week 4. |
| Other | Percentage of Participants With an Serious Adverse Event (SAE) From Randomization to Week 4 | Randomization to Week 4 | The secondary outcome is percentage of participants with an SAE from randomization to Week 4 |
| Other | Percentage of Participants With Symptomatic Hypotension From Randomization to Week 4 | Randomization to Week 4 | The Secondary Safety Outcome is percentage of participants with symptomatic hypotension from randomization to Week 4 |
| Other | Percentage of Participants With Serum Sodium Concentration Below 135 mmol/l at Week 4 | At Week 4 | The Secondary safety outcome is percentage of participants with serum sodium concentration below 135 mmol/l at Week 4 |
| Other | Percentage of Participants With Serum Sodium Concentration Above 145 mmol/l at Week 4 | At Week 4 | The Secondary safety outcome is percentage of participants with serum sodium concentration above 145 mmol/l at Week 4 |
| Other | The Percentage of Participants With Serum Potassium Concentration Below 3.5 mmol/l at Week 4 | At Week 4 | The secondary safety outcome is percentage of participants with serum potassium concentration below 3.5 mmol/l at Week 4 |
| Other | Percentage of Participants With Serum Potassium Concentration Above 5.5 mmol/l at Week 4 | At Week 4 | The secondary safety outcome is percentage of participants with serum potassium concentration above 5.5 mmol/l at Week 4. |
| Other | Percentage of Participants With eGFR Drop of Over 30% From Randomization to Week 4 | Randomization to Week 4 | The secondary safety outcome is percentage of participants with eGFR drop of over 30% from randomization to Week 4 |
| Other | 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 secondary safety outcome is 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 |
| Other | Percentage of Participants With Postural Hypotension at Week 4 | At Week 4 | The secondary safety outcome percentage of participants with postural hypotension at Week 4 |
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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