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Trial · NCT04518293

Outcomes40

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYDifference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Clinic Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Clinic Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <140 and Diastolic Blood Pressure (DBP) <90 mmHg at Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Clinic Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYDifference in Change in Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Home Seated Mean Diastolic Blood Pressure (DBP) From Randomization to Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYDifference in Change in Trough Home Seated Mean Systolic Blood Pressure (SBP) From Randomization to Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.mmHgLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <135 and Diastolic Blood Pressure (DBP) <85 mmHg at Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 12Week 12Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With Home Seated Mean Systolic Blood Pressure (SBP) <130 and Diastolic Blood Pressure (DBP) <80 mmHg at Week 6Week 6Analysis was performed on all participants who had been randomized. Participants were analyzed in the treatment group to which they had been randomized.ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDPercentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 12Week 12
Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDPercentage of Participants Discontinued Trial Medication Due to Adverse Event (AE)/Serious Adverse Event (SAE) From Randomization to Week 6Week 6
Analysis was done on the safety set which included all participants who had taken at least one dose of study treatment, including during Period 1 single-blind run-in. For the analysis of the safety outcomes, participants were analyzed in the treatment group that was received.
ParticipantsCOUNT_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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