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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 28, 2007 | ||||
| Last Updated Date | April 16, 2009 | ||||
| Start Date ICMJE | August 2005 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
The primary study endpoint will be the percentage of subjects achieving blood pressure goals (< 140/90 mmHg for non-diabetic subjects and < 130/80 mmHg in diabetic subjects) in the usual care and intervention subject groups [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00661895 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
New onset diabetes mellitus [ Time Frame: 3 month intervals ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Black Education and Treatment of Hypertension (BEAT HTN) | ||||
| Official Title ICMJE | Black Education and Treatment of Hypertension (BEAT HTN) | ||||
| Brief Summary | Clinical trials have yet to test the adequacy of HTN control in African Americans (AA) when both control and intervention groups are given free antihypertensive medications and are involved in usual versus intensive intervention strategies. Because of this, it has not yet been determined whether the method of prescribing antihypertensive medications according to JNC 7 guidelines is more, less, or equally as effective as prescribing antihypertensive medications and providing intensive behavioral and clinical interventions. Knowledge in this area of HTN treatment should better able medical and health practitioners to help their AA subjects control HTN. The BEAT Hypertension Clinic will evaluate this method of HTN control by proposing a program that will evaluate the difference in HTN control among subjects receiving usual care and free medications and subjects also receiving free medications, but additionally being treated in a clinic that operates in a more intensive manner in relationship to patient behavior modification, patient-clinician interactions, and physical and social environments. At the conclusion of the study, the BEAT Hypertension Clinic investigators will report findings and help to answer the question of whether medication alone or medication combined with intensive behavioral and clinical treatment is more effective in HTN control in the AA population. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 300 | ||||
| Completion Date | |||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 25 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00661895 | ||||
| Responsible Party | Syed Mohiuddin, MD, Creighton University | ||||
| Study ID Numbers ICMJE | 05-13859, 05-13589 | ||||
| Study Sponsor ICMJE | Creighton University | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Creighton University | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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