Black Education and Treatment of Hypertension (BEAT HTN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Creighton University
ClinicalTrials.gov Identifier:
NCT00661895
First received: December 28, 2007
Last updated: November 6, 2012
Last verified: November 2012
Results First Received: August 4, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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).
Control No intervention

Participant Flow:   Overall Study
    Intervention     Control  
STARTED     49     50  
COMPLETED     49     50  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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).
Control No intervention
Total Total of all reporting groups

Baseline Measures
    Intervention     Control     Total  
Number of Participants  
[units: participants]
  49     50     99  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     46     47     93  
>=65 years     3     3     6  
Age  
[units: years]
Mean ± Standard Deviation
  49.6  ± 9.81     50  ± 11     49.8  ± 10.4  
Gender  
[units: participants]
     
Female     33     39     72  
Male     16     11     27  
Region of Enrollment  
[units: participants]
     
United States     49     50     99  



  Outcome Measures

1.  Primary:   Percentage of Subjects Achieving Blood Pressure Goals   [ Time Frame: 3 month intervals ]

2.  Secondary:   New Onset Diabetes Mellitus   [ Time Frame: 3 month intervals ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Tammy Burns, PharmD, Research Manager
Organization: Creighton Cardiac Center
phone: 402-280-4292
e-mail: TammyBurns@creighton.edu


No publications provided


Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00661895     History of Changes
Other Study ID Numbers: 05-13859, 05-13589
Study First Received: December 28, 2007
Results First Received: August 4, 2011
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board