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Trial · NCT04518293

Registered outcomes40

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDifference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12Week 12
The primary outcome measure is difference in change in average home SBP for GMRx2 vs each dual combination evaluated from randomization to Week 12. The change in home SBP from randomization for all treatment arms was measured using least squares (LS) mean change. The pairwise comparisons between GMRx2 and dual treatments in change in home SBP were estimated using LS means difference and are described in the statistical analysis.
SecondaryDifference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12Week 12Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.
SecondaryDifference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6Week 6Difference in change in average clinic SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
SecondaryDifference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12Week 12Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.
SecondaryDifference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6Week 6Difference in change in average clinic DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
SecondaryPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12Week 12The percentage of participants achieving averaged clinic SBP \<140 mmHg and DBP \<90 mmHg at Week 12 was evaluated.
SecondaryPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6Week 6The percentage of participants achieving averaged clinic SBP \<140 mmHg and DBP \<80 mmHg at Week 6 was evaluated.
SecondaryPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12Week 12The percentage of participants achieving averaged clinic SBP \<130 mmHg and DBP \<80 mmHg at Week 12 was evaluated.
SecondaryPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6Week 6The percentage of participants achieving averaged clinic SBP \<130 mmHg and DBP \<80 mmHg at Week 6 was evaluated.
SecondaryDifference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6Week 6Difference in change in average home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
SecondaryDifference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12Week 12Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12.
SecondaryDifference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6Week 6Difference in change in average home DBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6.
SecondaryDifference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12Week 12Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 12. Trough values were measured before morning dose of the study medication.
SecondaryDifference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6Week 6Difference in change in trough home SBP for GMRx2 vs each dual combination was evaluated from randomization to Week 6. Trough values were measured before morning dose of the study medication.
SecondaryPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 12Week 12The percentage of participants achieving averaged home SBP \<135 mmHg and DBP \<85 mmHg at week 12 was calculated.
SecondaryPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 6Week 6The percentage of participants achieving averaged home SBP \<135 mmHg and DBP \<85 mmHg at Week 6 was evaluated.
SecondaryPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12Week 12The percentage of participants achieving averaged home SBP \<130 mmHg and DBP \<80 mmHg at Week 12 was evaluated.
SecondaryPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6Week 6The percentage of participants achieving averaged home SBP \<130 mmHg and DBP \<80 mmHg at Week 6 was evaluated.
OtherPercentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12Week 12The primary safety outcome is the proportion of participants who discontinued trial medication due to an AE or SAE from randomization to follow-up at Week 12.
OtherPercentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6Week 6The secondary safety outcome is the proportion of participants who discontinued trial medication due to AE/SAE from randomization to follow-up at Week 6.

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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