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Trial · NCT01876368

Registered outcomes11

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

ListOutcomeTime frameDescription
PrimaryChange From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)baseline, 8 weeks
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.
SecondaryChange From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)baseline, 8 weeks
Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)baseline, 8 weeks
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)baseline, 8 weeks
Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean
SecondaryChange From Baseline in Office Pulse Pressurebaseline, 8 weeksMean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.
SecondaryNumber of Patients Achieving Successful Overall Blood Pressure Control8 weeksSuccessful overall blood pressure control is defined as both msSBP/msDBP \<140/90 mmHg
SecondaryNumber of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control8 weeksSuccessful mean sitting systolic blood pressure control is defined as msSBP \<140 mmHg
SecondaryNumber of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control8 weeksSuccessful mean sitting diastolic blood pressure control is defined as msDBP \<90 mmHg
SecondaryNumber of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Responsebaseline, 8 weeksSuccessful mean sitting systolic blood pressure response is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline.
SecondaryNumber of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Responsebaseline, 8 weeksSuccessful mean sitting diastolic blood pressure response is defined as msDBP \<90 mmHg or a reduction ≥10 mmHg from baseline.
SecondaryNumber of Patients With Total Adverse Events, Serious Adverse Events and Death8 weeksNumber of patients with total adverse events, serious adverse events and death were reported.

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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