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Trial · NCT00818883

Outcomes15

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange From Baseline in Trough, Sitting, Clinic Systolic Blood PressureBaseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Trough, Sitting, Clinic Diastolic Blood PressureBaseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Mean Trough Systolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in Mean Trough Diastolic Blood Pressure (22 to 24 Hours After Dosing) as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 24-hour Mean Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in 24-hour Mean Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Mean Daytime (6 AM to 10 PM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Mean Daytime (6 AM to 10 PM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Mean Nighttime (12 AM to 6 AM) Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Mean Nighttime (12 AM to 6 AM) Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Mean Systolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure MonitoringBaseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARYChange From Baseline in the Mean Diastolic Blood Pressure at 0 to 12 Hours After Dosing as Measured by Ambulatory Blood Pressure Monitoring.Baseline, Week 6 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
mmHgLEAST_SQUARES_MEAN
SECONDARY
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic Blood Pressure Targets, Defined as <140 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <130 mm Hg for Participants With Diabetes or Chronic Kidney Disease
Week 2, Week 4, Week 6, Week 8 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
percentage of participantsNUMBER
SECONDARY
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Diastolic Blood Pressure Target, Defined as <90 mm Hg for Participants Without Diabetes or Chronic Kidney Disease or <80 mm Hg for Participants With Diabetes or Chronic Kidney Disease.
Week 2, Week 4, Week 6, Week 8 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
percentage of participantsNUMBER
SECONDARY
Percentage of Participants Who Reached Their Trough, Sitting, Clinic Systolic and Diastolic Blood Pressure Targets, Defined as <140/90 mm Hg Without Diabetes or Chronic Kidney Disease or <130/80 mm Hg With Diabetes or Chronic Kidney Disease
Week 2, Week 4, Week 6, Week 8 and Week 10.
Full analysis set, defined as all randomized participants who received at least 1 dose of active single-blind or double-blind study medication, with both a baseline value and at least 1 value during the treatment period, with last observation carried forward.
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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