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Sponsored by: |
Creighton University |
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Information provided by: | Creighton University |
ClinicalTrials.gov Identifier: | NCT00661895 |
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.
Condition | Intervention | Phase |
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Hypertension |
Drug: Hydrochlorothiazide Drug: Lisinopril Drug: Lisinopril and Hydrochlorothiazide Drug: Nifedipine XL Drug: Metoprolol tartrate (Lopressor) Drug: Atenolol Drug: Valsartan Drug: Doxazosin Drug: Clonidine Drug: Hydralazine Drug: Metoprolol succinate (Toprol XL) Drug: Amlodipine (Norvasc) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Black Education and Treatment of Hypertension (BEAT HTN) |
Estimated Enrollment: | 300 |
Study Start Date: | August 2005 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg tablets
Drug: Lisinopril
Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
Drug: Lisinopril and Hydrochlorothiazide
L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets
Drug: Nifedipine XL
30 mg extended release tablets, 60 mg extended release tablets
Drug: Metoprolol tartrate (Lopressor)
50 mg tablets & 100 mg tablets
Drug: Atenolol
50 mg tablet
Drug: Valsartan
80 mg tablets & 160 mg tablet
Drug: Doxazosin
4 mg tablets
Drug: Clonidine
0.2 mg tablets
Drug: Hydralazine
50 mg tablets
Drug: Metoprolol succinate (Toprol XL)
50 mg tablet & 100 mg tablet
Drug: Amlodipine (Norvasc)
5 mg tablets & 10 mg tablets
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2: Active Comparator |
Drug: Hydrochlorothiazide
Hydrochlorothiazide 25 mg tablets
Drug: Lisinopril
Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
Drug: Lisinopril and Hydrochlorothiazide
L 10 mg and H 12.5 mg tablets, L 20 mg and H 12.5 mg tablets, L 20 mg and H 25 mg tablets
Drug: Nifedipine XL
30 mg extended release tablets, 60 mg extended release tablets
Drug: Metoprolol tartrate (Lopressor)
50 mg tablets & 100 mg tablets
Drug: Atenolol
50 mg tablet
Drug: Valsartan
80 mg tablets & 160 mg tablet
Drug: Doxazosin
4 mg tablets
Drug: Clonidine
0.2 mg tablets
Drug: Hydralazine
50 mg tablets
Drug: Metoprolol succinate (Toprol XL)
50 mg tablet & 100 mg tablet
Drug: Amlodipine (Norvasc)
5 mg tablets & 10 mg tablets
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Ages Eligible for Study: | 25 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study eligibility will be based on the subject's current blood pressure control based on the average of two seated blood pressure measurements at two consecutive clinic visits at least one week apart
Exclusion Criteria:
Contact: Syed Mohiuddin, MD | 402-280-4570 | smm@creighton.edu |
United States, Nebraska | |
Creighton Community Health Center | Recruiting |
Omaha, Nebraska, United States, 68104 | |
Contact: Stephanie Maciejewski, PharmD 402-280-4292 smacieje@cardiac.creighton.edu |
Principal Investigator: | Syed Mohiuddin, MD | Creighton University |
Responsible Party: | Creighton University ( Syed Mohiuddin, MD ) |
Study ID Numbers: | 05-13859, 05-13589 |
Study First Received: | December 28, 2007 |
Last Updated: | July 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00661895 |
Health Authority: | United States: Institutional Review Board |
African American |
Lisinopril Clonidine Hydralazine Vascular Diseases Metoprolol Nifedipine Hydrochlorothiazide |
Doxazosin Amlodipine Calcium, Dietary Metoprolol succinate Atenolol Valsartan Hypertension |
Neurotransmitter Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Cardiotonic Agents Physiological Effects of Drugs Diuretics Sodium Chloride Symporter Inhibitors Calcium Channel Blockers Reproductive Control Agents Membrane Transport Modulators Tocolytic Agents Therapeutic Uses Adrenergic beta-Antagonists |
Angiotensin-Converting Enzyme Inhibitors Cardiovascular Diseases Anti-Arrhythmia Agents Sympatholytics Enzyme Inhibitors Cardiovascular Agents Antihypertensive Agents Protective Agents Pharmacologic Actions Protease Inhibitors Autonomic Agents Natriuretic Agents Adrenergic Antagonists Peripheral Nervous System Agents |