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Black Education and Treatment of Hypertension (BEAT HTN)

NCT ID: NCT00661895

Last Updated: 2012-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2009-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hypertension

Keywords

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African American

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention

Intervention group subjects will receive education and assistance from a Community Health Center or Cardiac Center nurse practitioner or physician, health educator, dietitian, social worker, and Cardiac Center-trained community members called Community Health Advocates (CHAs).

Group Type EXPERIMENTAL

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 25 mg tablets

Lisinopril

Intervention Type DRUG

Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet

Lisinopril and Hydrochlorothiazide

Intervention Type DRUG

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

Nifedipine XL

Intervention Type DRUG

30 mg extended release tablets, 60 mg extended release tablets

Metoprolol tartrate

Intervention Type DRUG

50 mg tablets \& 100 mg tablets

Atenolol

Intervention Type DRUG

50 mg tablet

Valsartan

Intervention Type DRUG

80 mg tablets \& 160 mg tablet

Doxazosin

Intervention Type DRUG

4 mg tablets

Clonidine

Intervention Type DRUG

0.2 mg tablets

Hydralazine

Intervention Type DRUG

50 mg tablets

Metoprolol succinate

Intervention Type DRUG

50 mg tablet \& 100 mg tablet

Amlodipine

Intervention Type DRUG

5 mg tablets \& 10 mg tablets

Control

No intervention

Group Type ACTIVE_COMPARATOR

Hydrochlorothiazide

Intervention Type DRUG

Hydrochlorothiazide 25 mg tablets

Lisinopril

Intervention Type DRUG

Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet

Lisinopril and Hydrochlorothiazide

Intervention Type DRUG

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

Nifedipine XL

Intervention Type DRUG

30 mg extended release tablets, 60 mg extended release tablets

Metoprolol tartrate

Intervention Type DRUG

50 mg tablets \& 100 mg tablets

Atenolol

Intervention Type DRUG

50 mg tablet

Valsartan

Intervention Type DRUG

80 mg tablets \& 160 mg tablet

Doxazosin

Intervention Type DRUG

4 mg tablets

Clonidine

Intervention Type DRUG

0.2 mg tablets

Hydralazine

Intervention Type DRUG

50 mg tablets

Metoprolol succinate

Intervention Type DRUG

50 mg tablet \& 100 mg tablet

Amlodipine

Intervention Type DRUG

5 mg tablets \& 10 mg tablets

Interventions

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Hydrochlorothiazide

Hydrochlorothiazide 25 mg tablets

Intervention Type DRUG

Lisinopril

Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet

Intervention Type 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

Intervention Type DRUG

Nifedipine XL

30 mg extended release tablets, 60 mg extended release tablets

Intervention Type DRUG

Metoprolol tartrate

50 mg tablets \& 100 mg tablets

Intervention Type DRUG

Atenolol

50 mg tablet

Intervention Type DRUG

Valsartan

80 mg tablets \& 160 mg tablet

Intervention Type DRUG

Doxazosin

4 mg tablets

Intervention Type DRUG

Clonidine

0.2 mg tablets

Intervention Type DRUG

Hydralazine

50 mg tablets

Intervention Type DRUG

Metoprolol succinate

50 mg tablet \& 100 mg tablet

Intervention Type DRUG

Amlodipine

5 mg tablets \& 10 mg tablets

Intervention Type DRUG

Other Intervention Names

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Lopressor Toprol XL Norvasc

Eligibility Criteria

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Inclusion Criteria

1. Demographics: men or women of self-declared African-American heritage between 25 and 80 years of age residing in the Omaha, Nebraska metropolitan area
2. History of documented uncontrolled (treated or untreated) hypertension (HTN) as defined by JNC 7 guidelines
3. 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

1. Untreated subjects with elevated blood pressure (\> 140/90 mmHg or \< 130/80 mmHg for diabetics)
2. Subjects treated with antihypertensive therapy whose blood pressure does not meet current JNC 7 guidelines (\< 140/90 mmHg for non-diabetics and \< 130/80 mmHg for diabetics)

Exclusion Criteria

1. Myocardial infarction or stroke in the previous 6 months
2. Symptomatic heart failure or a left ventricular ejection fraction \< 35%
3. Angina pectoris in the prior six months
4. Coronary revascularization procedure in the prior 6 months
5. Renal insufficiency defined as a serum creatinine \> 2 mg/dl
6. Illicit drug or alcohol abuse in the prior 6 months
7. Dementia or other organic brain disease
8. Serious systemic illness with a shortened life expectancy or other limitation that precludes participation in this trial
9. Secondary HTN
10. Concurrent participation in an investigational medication trial
Minimum Eligible Age

25 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Creighton University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Syed Mohiuddin, MD

Role: PRINCIPAL_INVESTIGATOR

Creighton University

Locations

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Creighton Community Health Center

Omaha, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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05-13859

Identifier Type: -

Identifier Source: org_study_id

05-13589

Identifier Type: OTHER

Identifier Source: secondary_id