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Trial record 63 of 65 for:    HYDROCHLOROTHIAZIDE AND VALSARTAN

Black Education and Treatment of Hypertension (BEAT HTN) (BEAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661895
Recruitment Status : Completed
First Posted : April 21, 2008
Results First Posted : December 4, 2012
Last Update Posted : December 4, 2012
Sponsor:
Information provided by (Responsible Party):
Creighton University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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
Enrollment 99
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Control
Hide Arm/Group Description 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). No intervention
Period Title: Overall Study
Started 49 50
Completed 49 50
Not Completed 0 0
Arm/Group Title Intervention Control Total
Hide Arm/Group Description 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). No intervention Total of all reporting groups
Overall Number of Baseline Participants 49 50 99
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
46
  93.9%
47
  94.0%
93
  93.9%
>=65 years
3
   6.1%
3
   6.0%
6
   6.1%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 50 participants 99 participants
49.6  (9.81) 50  (11) 49.8  (10.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 50 participants 99 participants
Female
33
  67.3%
39
  78.0%
72
  72.7%
Male
16
  32.7%
11
  22.0%
27
  27.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants 50 participants 99 participants
49 50 99
1.Primary Outcome
Title Percentage of Subjects Achieving Blood Pressure Goals
Hide Description Percentage of subjects who achieved JNC-VII defined blood pressure goals.
Time Frame 3 month intervals
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention Control
Hide Arm/Group Description:
Free antihypertensive medications, in-depth HTN and healthy living education, behavior change counseling, and Therapeutic Lifestyle Change following JNC-VII guidelines.
Free antihypertensive medications, basic hypertension education and usual clinical care.
Overall Number of Participants Analyzed 49 50
Measure Type: Number
Unit of Measure: percentage of participants
81 57
2.Secondary Outcome
Title New Onset Diabetes Mellitus
Hide Description [Not Specified]
Time Frame 3 month intervals
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Control
Hide Arm/Group Description 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). No intervention
All-Cause Mortality
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/50 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intervention Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)   0/50 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Tammy Burns, PharmD, Research Manager
Organization: Creighton Cardiac Center
Phone: 402-280-4292
EMail: TammyBurns@creighton.edu
Layout table for additonal information
Responsible Party: Creighton University
ClinicalTrials.gov Identifier: NCT00661895     History of Changes
Other Study ID Numbers: 05-13859
05-13589 ( Other Identifier: Creighton University Institutional Review Board )
First Submitted: December 28, 2007
First Posted: April 21, 2008
Results First Submitted: August 4, 2011
Results First Posted: December 4, 2012
Last Update Posted: December 4, 2012