Pharmacogenomic Evaluation of Antihypertensive Responses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Julie A Johnson, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier:
NCT00246519
First received: October 27, 2005
Last updated: July 8, 2013
Last verified: July 2013
Results First Received: May 20, 2013  
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: HCTZ + atenolol
Drug: Atenolol + HCTZ

  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
Subjects were recuited to 3 sites, the University of Florida, Mayo Clinic in Rochester MN, and Emory University. Subjects were seen in medical clinics by physcians and/or nurse coordinators. Patients were recruited from 2005-2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment subjects were currently on medication for blood pressure were required to wash out for a minimum of 2-4 weeks, at which point the blood pressure was reassessed for eligibility into the study. Of the 1701 subjects who enrolled in the study, 888 subjects met eligibility requirements to continue the study while 813 subjects did not.

Reporting Groups
  Description
Atenolol +HCTZ Arm atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
HCTZ + Atenolol HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.

Participant Flow:   Overall Study
    Atenolol +HCTZ Arm     HCTZ + Atenolol  
STARTED     442     446  
COMPLETED     386     382  
NOT COMPLETED     56     64  



  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
Atenolol +HCTZ Arm atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
HCTZ + Atenolol HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
Total Total of all reporting groups

Baseline Measures
    Atenolol +HCTZ Arm     HCTZ + Atenolol     Total  
Number of Participants  
[units: participants]
  442     446     888  
Age  
[units: participants]
     
<=18 years     1     0     1  
Between 18 and 65 years     437     440     877  
>=65 years     4     6     10  
Age  
[units: years]
Mean ± Standard Deviation
  48.4  ± 9.3     48.8  ± 9.2     48.6  ± 9.3  
Gender  
[units: participants]
     
Female     251     223     474  
Male     191     223     414  
Region of Enrollment  
[units: participants]
     
United States     442     446     888  



  Outcome Measures

1.  Primary:   Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).   [ Time Frame: baseline to 18 weeks of treatment ]

2.  Secondary:   Adverse Metabolic Responses   [ Time Frame: 9-18 weeks of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The trial has limited number of hypertensive patients of African ancestry, therefore power is limited to those patients.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Julie A. Johnson
Organization: University of Florida
phone: 352-273-6007
e-mail: johnson@cop.ufl.edu


Publications of Results:

Publications automatically indexed to this study:

Responsible Party: Dr. Julie A Johnson, National Institute of General Medical Sciences (NIGMS)
ClinicalTrials.gov Identifier: NCT00246519     History of Changes
Other Study ID Numbers: U01 GM074492
Study First Received: October 27, 2005
Results First Received: May 20, 2013
Last Updated: July 8, 2013
Health Authority: United States: Federal Government