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Trial · NCT00846365

Outcomes16

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure.Baseline and Week 8.Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward.mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline to Week 4 in Trough, Sitting, Clinic Systolic Blood Pressure.Baseline and Week 4.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Trough, Sitting, Clinic Diastolic Blood PressureBaseline, Week 4 and Week 8.
Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Trough Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Trough Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Daytime Mean (6am to 10pm) Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set , all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Daytime Mean (6am to 10pm) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Nighttime Mean (12am to 6am) Systolic Blood Pressure Measured by Ambulatory Blood Pressure MonitoringBaseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Nighttime Mean (12am to 6am) Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 12-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 12-hr Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 4 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
mmHgLEAST_SQUARES_MEAN
SECONDARYPercentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as <140 mm Hg for Participants Without Diabetes or CKD or <130 mm Hg for Participants With Diabetes or CKDBaseline, Week 2, Week 4, Week 6 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
percentage of participantsNUMBER
SECONDARY
Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as Defined as <90 mm Hg for Participants Without Diabetes or CKD or <80 mm Hg for Participants With Diabetes or CKD
Baseline, Week 2, Week 4, Week 6 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
percentage of participantsNUMBER
SECONDARY
Percentage of Participants Who Achieve a Clinic Diastolic AND Systolic Blood Pressure Response, Defined as <140/90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease (CKD) or <130/80 mm Hg for Participants With Diabetes or CKD
Baseline, Week 2, Week 4, Week 6 and Week 8.
Full analysis set, all participants that took at least 1 dose of double-blind study drug and have a baseline and post-baseline value, with last observation carried forward. Participants who had not achieved target systolic blood pressure/diastolic blood pressure were titrated to the higher dose at week 4.
percentage of participantsNUMBER

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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