Trial · NCT01599104
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | Baseline, 8 weeks | Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 | Baseline, 8 weeks | Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants. |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Baseline, 8 weeks | Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline. |
| Secondary | Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 | 8 weeks | A successful response in overall BP control rate was defined as msSBP \< 140 mmHg and msDBP \<90 mmHg. |
| Secondary | Percentage of Participants Achieving a Successful msSBP Response | 8 weeks | Successful msSBP response was defined as \< 140 mmHg or ≥ 20 mmHg reduction from baseline. |
| Secondary | Percentage of Participants Achieving a Successful msDBP Response | 8 weeks | Successfull msDBP response was defined as \<90 mmHg or ≥10 mmHg reduction from baseline. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8 | Baseline, 8 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. |
| Secondary | Change From Baseline in maSBP and maDBP for Daytime/Nighttime | Baseline, 8 weeks | ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants. |
| Secondary | Change From Baseline in Office Pulse Pressure | Baseline, 8 weeks | Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure | Baseline, 8 weeks | Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants. |
| Secondary | Number of Patients With Adverse Events, Serious Adverse Events and Death | 8 weeks | Participants were monitored for adverse events, serious adverse events and deaths throughout the study. |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT01599104/registered