HypertensionPhase 4BEATNCT00661895
Black Education and Treatment of Hypertension (BEAT HTN)
A Phase 4 study testing Hydrochlorothiazide, Lisinopril and Lisinopril and Hydrochlorothiazide in people with Hypertension, run by Creighton University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Hydrochlorothiazide, Lisinopril and Lisinopril and Hydrochlorothiazide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Nov 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Demographics: men or women of self-declared African-American heritage between 25 and 80 years of age residing in the Omaha, Nebraska metropolitan area
- History of documented uncontrolled (treated or untreated) hypertension (HTN) as defined by JNC 7 guidelines
- 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
- Untreated subjects with elevated blood pressure (> 140/90 mmHg or < 130/80 mmHg for diabetics)
- 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)
Who cannot join
- Myocardial infarction or stroke in the previous 6 months
- Symptomatic heart failure or a left ventricular ejection fraction < 35%
- Angina pectoris in the prior six months
- Coronary revascularization procedure in the prior 6 months
- Renal insufficiency defined as a serum creatinine > 2 mg/dl
- Illicit drug or alcohol abuse in the prior 6 months
Show all 10Show fewer
- Dementia or other organic brain disease
- Serious systemic illness with a shortened life expectancy or other limitation that precludes participation in this trial
- Secondary HTN
- Concurrent participation in an investigational medication trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton Community Health Center
Omaha, Nebraska, 68104
About this study
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.
- Conditions
- Hypertension
- Being tested
- Hydrochlorothiazide, Lisinopril, Lisinopril and Hydrochlorothiazide, Nifedipine XL, Metoprolol tartrate
- Keywords
- African American
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrochlorothiazideDrug
Hydrochlorothiazide 25 mg tablets
LisinoprilDrug
Lisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet
Lisinopril and HydrochlorothiazideDrug
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 XLDrug
30 mg extended release tablets, 60 mg extended release tablets
Metoprolol tartrateDrug
Also called Lopressor
50 mg tablets \& 100 mg tablets
AtenololDrug
50 mg tablet
ValsartanDrug
80 mg tablets \& 160 mg tablet
DoxazosinDrug
4 mg tablets
ClonidineDrug
0.2 mg tablets
HydralazineDrug
50 mg tablets
Metoprolol succinateDrug
Also called Toprol XL
50 mg tablet \& 100 mg tablet
AmlodipineDrug
Also called Norvasc
5 mg tablets \& 10 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Drug: Hydrochlorothiazide; Drug: Lisinopril; Drug: Lisinopril and Hydrochlorothiazide; Drug: Nifedipine XL; Drug: Metoprolol tartrate; Drug: Atenolol; Drug: Valsartan; Drug: Doxazosin; Drug: Clonidine; Drug: Hydralazine; Drug: Metoprolol succinate; Drug: Amlodipine |
| Control | Active comparator | No intervention Receives: Drug: Hydrochlorothiazide; Drug: Lisinopril; Drug: Lisinopril and Hydrochlorothiazide; Drug: Nifedipine XL; Drug: Metoprolol tartrate; Drug: Atenolol; Drug: Valsartan; Drug: Doxazosin; Drug: Clonidine; Drug: Hydralazine; Drug: Metoprolol succinate; Drug: Amlodipine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Achieving Blood Pressure Goals
Percentage of subjects who achieved JNC-VII defined blood pressure goals.
Measured: 3 month intervals
Secondary outcomes (1)
New Onset Diabetes Mellitus
Measured: 3 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startAug 2005
- Primary completionAug 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Syed Mohiuddin, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00661895
- Sponsor's protocol ID
- 05-13859
- Other IDs
- 05-13589
- Acronym
- BEAT
- Status last verified
- Nov 2012
- First submitted
- 28 Dec 2007
- Last updated
- 4 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Black Education and Treatment of Hypertension (BEAT HTN)
- ClinicalTrials.gov ID
- NCT00661895
- Acronym / sponsor ID
- BEAT / 05-13859
- Conditions
- Hypertension
- Keywords
- African American
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Posted 4 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Hydrochlorothiazide, Drug: Lisinopril, Drug: Lisinopril and Hydrochlorothiazide, Drug: Nifedipine XL, Drug: Metoprolol tartrate, Drug: Atenolol, Drug: Valsartan, Drug: Doxazosin, Drug: Clonidine, Drug: Hydralazine, Drug: Metoprolol succinate, Drug: AmlodipineIntervention 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). |
| Control | Active comparator | Drug: Hydrochlorothiazide, Drug: Lisinopril, Drug: Lisinopril and Hydrochlorothiazide, Drug: Nifedipine XL, Drug: Metoprolol tartrate, Drug: Atenolol, Drug: Valsartan, Drug: Doxazosin, Drug: Clonidine, Drug: Hydralazine, Drug: Metoprolol succinate, Drug: AmlodipineNo intervention |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Demographics: men or women of self-declared African-American heritage between 25 and 80 years of age residing in the Omaha, Nebraska metropolitan area
- History of documented uncontrolled (treated or untreated) hypertension (HTN) as defined by JNC 7 guidelines
- 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
Key exclusion criteria (10 listed)
- Myocardial infarction or stroke in the previous 6 months
- Symptomatic heart failure or a left ventricular ejection fraction < 35%
- Angina pectoris in the prior six months
- Coronary revascularization procedure in the prior 6 months
- Renal insufficiency defined as a serum creatinine > 2 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydrochlorothiazideHydrochlorothiazide 25 mg tablets | Drug | Control, Intervention |
| LisinoprilLisinopril 5mg Tablet, 10 mg tablet, 20 mg tablet | Drug | Control, Intervention |
| Lisinopril and HydrochlorothiazideL 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 | Control, Intervention |
| Nifedipine XL30 mg extended release tablets, 60 mg extended release tablets | Drug | Control, Intervention |
| Metoprolol tartrateAlso: Lopressor50 mg tablets \& 100 mg tablets | Drug | Control, Intervention |
| Atenolol50 mg tablet | Drug | Control, Intervention |
| Valsartan80 mg tablets \& 160 mg tablet | Drug | Control, Intervention |
| Doxazosin4 mg tablets | Drug | Control, Intervention |
| Clonidine0.2 mg tablets | Drug | Control, Intervention |
| Hydralazine50 mg tablets | Drug | Control, Intervention |
| Metoprolol succinateAlso: Toprol XL50 mg tablet \& 100 mg tablet | Drug | Control, Intervention |
| AmlodipineAlso: Norvasc5 mg tablets \& 10 mg tablets | Drug | Control, Intervention |
Primary outcome
Percentage of Subjects Achieving Blood Pressure Goals
Time frame: 3 month intervals
Percentage of subjects who achieved JNC-VII defined blood pressure goals.
1 secondary outcome
New Onset Diabetes Mellitus
Time frame: 3 month intervals
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Mohiuddin, MD principal investigator
Creighton University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydrochlorothiazide, Lisinopril and Lisinopril and Hydrochlorothiazide in people with Hypertension, run by Creighton University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects Achieving Blood Pressure Goals (time frame: 3 month intervals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2012.