Trial · NCT00902304
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Who Have Achieved Their Pre-specified (Individualized National Heart Foundation of Australia Criteria) Blood Pressure (BP) Target | 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis. | percentage of participants | NUMBER |
| SECONDARY | Change in Mean Sitting Systolic Blood Pressure | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Mean Sitting Diastolic Blood Pressure | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Last Observation Carried Forward (LOCF) imputation technique is used for this analysis. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Absolute Cardiovascular Risk Score | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | percentage risk score change | MEAN |
| SECONDARY | Number of Patients With at Least One Adverse Events Attributable to Anti-hypertensive Therapy | 26 weeks | Safety analysis - consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment. | participants | NUMBER |
| SECONDARY | Number of 'Early Responder' Patients Who Achieve Individualized Blood Pressure Control After 1 or 2 Adjustments | 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. | Participants | NUMBER |
| SECONDARY | Change in the EQ-5D Score | Baseline and 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | change in EQ-5D score | MEAN |
| SECONDARY | Number of Patients With Depression | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | participants | NUMBER |
| SECONDARY | Change in Center for Epidemiologic Studies Depression (CES-D) Score From Baseline to Week 26 | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | change in CES-D score | MEAN |
| SECONDARY | Participants With End Organ Disease at Baseline and Week 26 | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. | participants | NUMBER |
| SECONDARY | Change in Self-care Behavior Score From Baseline to Week 26 | Baseline and week 26 | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. Only patients with measurements at both baseline and week 26 were included in this analysis. | Change in score | MEAN |
| SECONDARY | Rate of Treatment Compliance | 26 weeks | This data will not be analyzed due to the poor quality of the data. | ||
| SECONDARY | Number of Patients With Major Clinical Endpoints | 26 weeks | Intent-to-treat (ITT) - ITT population consisted of all subjects randomized to a study intervention arm and who commenced study management and/or treatment and who had at least one recorded BP post randomization. | 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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