Trial · NCT01876368
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP) | baseline, 8 weeks | A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP) | baseline, 8 weeks | A subset of randomized participants, who had ABPM measurements at both baseline and week 8, were included in the analysis. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Office Pulse Pressure | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Patients Achieving Successful Overall Blood Pressure Control | 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control | 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control | 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS. | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Participants | NUMBER |
| SECONDARY | Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response | baseline, 8 weeks | Full Analysis Set (FAS) - All patients who were randomized. Following the intent to treat principle, patients were analyzed according to the treatment they were assigned to at the randomization. However, patients who were not qualified for randomization and were inadvertently randomized into the study were excluded from the FAS | Participants | NUMBER |
| SECONDARY | Number of Patients With Total Adverse Events, Serious Adverse Events and Death | 8 weeks | Safety Set (SAF) - All patients who received at least one dose of study medication in the double-blind epoch. Patients were analyzed according to the treatment they received. One patient was not included in the SAF due to mis-randomization. | Number of participants | NUMBER |
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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