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Trial record 60 of 116 for:    Atenolol

Pharmacogenomic Evaluation of Antihypertensive Responses

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ClinicalTrials.gov Identifier: NCT00246519
Recruitment Status : Completed
First Posted : October 31, 2005
Results First Posted : July 10, 2013
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Hydrochlorothiazide
Drug: Atenolol
Enrollment 1701
Recruitment Details Subjects were recruited to 3 sites, the University of Florida, Mayo Clinic in Rochester Minnesota, and Emory University. Subjects were seen in medical clinics by physicians and/or nurse coordinators. Patients were recruited from 2005-2010.
Pre-assignment Details 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.
Arm/Group Title Atenolol + Hydroclorothiazide (HCTZ) Arm Hydrochlorothiazide (HCTZ) + Atenolol
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 442 446
Completed 386 382
Not Completed 56 64
Arm/Group Title Atenolol +HCTZ Arm HCTZ + Atenolol Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 442 446 888
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 442 participants 446 participants 888 participants
<=18 years
1
   0.2%
0
   0.0%
1
   0.1%
Between 18 and 65 years
437
  98.9%
440
  98.7%
877
  98.8%
>=65 years
4
   0.9%
6
   1.3%
10
   1.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 442 participants 446 participants 888 participants
48.4  (9.3) 48.8  (9.2) 48.6  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 442 participants 446 participants 888 participants
Female
251
  56.8%
223
  50.0%
474
  53.4%
Male
191
  43.2%
223
  50.0%
414
  46.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 442 participants 446 participants 888 participants
442 446 888
1.Primary Outcome
Title Blood Pressure Response (Delta BP (After 18 Weeks of Medication - Baseline)).
Hide Description [Not Specified]
Time Frame baseline to 18 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
A total 768 patients had at least monotherapy response data. Of the 386 patients assigned to the atenolol arm, 357 completed both drugs. Of the 382 assigned to the HCTZ arm, 355 completed both drugs. The delta blood pressure below is for patients who completed both drugs.
Arm/Group Title Atenolol +HCTZ Arm HCTZ + Atenolol
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 357 355
Mean (Standard Deviation)
Unit of Measure: mmHg
-12.06  (6.96) -13.33  (6.80)
2.Secondary Outcome
Title Adverse Metabolic Responses
Hide Description [Not Specified]
Time Frame 9-18 weeks of treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Atenolol +HCTZ Arm HCTZ + Atenolol
Hide Arm/Group Description 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 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.
All-Cause Mortality
Atenolol +HCTZ Arm HCTZ + Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Atenolol +HCTZ Arm HCTZ + Atenolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/386 (0.26%)      3/382 (0.79%)    
Cardiac disorders     
Chest Pain   0/386 (0.00%)  0 2/382 (0.52%)  2
Gastrointestinal disorders     
Inflamed colon or colonitis * [1]  1/386 (0.26%)  1 1/382 (0.26%)  1
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
1 had inflamed colon; 1 had colon colitis
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Atenolol +HCTZ Arm HCTZ + Atenolol
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   202/386 (52.33%)      190/382 (49.74%)    
Cardiac disorders     
Bradycardia   1/386 (0.26%)  1 4/382 (1.05%)  4
Hypokalemia   0/386 (0.00%)  0 1/382 (0.26%)  1
Chest pain   2/386 (0.52%)  2 6/382 (1.57%)  6
Gastrointestinal disorders     
Nausea   4/386 (1.04%)  4 3/382 (0.79%)  3
Diarrhea   7/386 (1.81%)  8 2/382 (0.52%)  2
General disorders     
Tiredness/Fatigue   21/386 (5.44%)  21 25/382 (6.54%)  25
Dizziness   12/386 (3.11%)  12 13/382 (3.40%)  13
Headache   23/386 (5.96%)  23 35/382 (9.16%)  38
Hospitalization   1/386 (0.26%)  1 0/382 (0.00%)  0
Other   123/386 (31.87%)  123 98/382 (25.65%)  99
Nervous system disorders     
Depression   2/386 (0.52%)  2 0/382 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Wheezing   3/386 (0.78%)  3 0/382 (0.00%)  0
Dyspnea   1/386 (0.26%)  1 2/382 (0.52%)  2
Skin and subcutaneous tissue disorders     
Rash   2/386 (0.52%)  2 2/382 (0.52%)  2
Indicates events were collected by systematic assessment
The trial has limited number of hypertensive patients of African ancestry, therefore power is limited to those patients.
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
Layout table for Results Point of Contact information
Name/Title: Julie A. Johnson
Organization: University of Florida
Phone: 352-273-6007
EMail: johnson@cop.ufl.edu
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00246519     History of Changes
Other Study ID Numbers: U01GM074492 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2005
First Posted: October 31, 2005
Results First Submitted: May 20, 2013
Results First Posted: July 10, 2013
Last Update Posted: May 7, 2018