Trial · NCT03640312
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Mean Systolic Blood Pressure | 12 weeks | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. |
| Secondary | Mean Systolic Blood Pressure | 6 weeks | Mean automated office systolic blood pressure adjusted for baseline values. |
| Secondary | Change in Mean Diastolic Blood Pressure | 6 weeks | Mean change (from baseline) in automated office diastolic blood pressure adjusted for baseline values. |
| Secondary | Mean Diastolic Blood Pressure | 6 weeks | Mean automated office diastolic blood pressure adjusted for baseline values. |
| Secondary | Proportion of Patients With Hypertension Control | 6 and 12 weeks | Proportion of patients with hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg). |
| Secondary | Number of Patients Requiring Step up Treatment | 6 weeks | Number of patients requiring step-up treatment. |
| Secondary | Proportion of Patients With Adverse Event Free Hypertension Control | 12 weeks | Proportion of patients with adverse event free hypertension control (percent with SBP \< 130 mmHg and DBP \<80 mmHg). |
| Secondary | Medication Adherence | 12 weeks | Medication adherence defined by objective pill counts |
| Secondary | Health-related Quality of Life | 12 weeks | Mean change (from baseline) in health-related quality of life using Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health instrument. PROMIS Global Health is a gauge of general health-care related quality of life. Possible PROMIS Global Physical Health and Global Mental Health scores range from 0-20, with 20 indicating best possible state of health. Raw scores are converted to T-scores to compare to a standardized population. A PROMIS T-score of 50 represents the mean of the population (SD = 10). Higher values here also indicate better health. A positive change in T score, as reported in this outcome measure, would represent an improvement in Global Physical Health or Global Mental Health at 12 weeks compared to baseline. |
| Secondary | Change in Mean Systolic Blood Pressure | 6 weeks | Mean change (from baseline) in automated office systolic blood pressure adjusted for baseline values. |
| Other | Percentage of Participants With Serious Adverse Events (SAEs) | 12 weeks | Percentage of participants with any Serious Adverse Events (SAE) according to Good Clinical Practice definition: adverse events that result in death, are life threatening, require hospitalization or prolong existing hospitalization, result in persistent disability, result in congenital anomaly or birth defect, or unimportant medical event that requires intervention to prevent any of the above. |
| Other | Percentage of Participants With Potentially Related Adverse Events | 12 weeks | Percentage of participants with occurrence of any potentially related adverse event (pre-specified as in study procedures). Defined as: At least possibly related to study drug. |
| Other | Rate of Adverse Events of Special Interest | 12 weeks | Rate of pre-specified adverse events that are known side effects of active ingredients at the participant level. |
| Other | Mean Change in Serum Potassium | 12 weeks | Mean change (from baseline) in continuous serum potassium. |
| Other | Mean Change in Serum Sodium | 12 weeks | Mean change (from baseline) in continuous serum sodium. |
| Other | Mean Change in Blood Urea Nitrogen | 12 weeks | Mean change (from baseline) in continuous blood urea nitrogen. |
| Other | Mean Change in Serum Creatinine | 12 weeks | Mean change in continuous serum creatinine. |
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
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GET https://conductscience.org/api/trials/v1/NCT03640312/registered