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Trial record 18 of 117 for:    Atenolol

Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure

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: NCT00669279
Recruitment Status : Completed
First Posted : April 30, 2008
Results First Posted : March 23, 2012
Last Update Posted : October 5, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Florida

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Hypertension
Interventions Drug: Carvedilol CR
Drug: Atenolol
Enrollment 41
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carvedilol CR Atenolol
Hide Arm/Group Description Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two. Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
Period Title: Overall Study
Started 22 19
Completed 22 19
Not Completed 0 0
Arm/Group Title Carvedilol CR Atenolol Total
Hide Arm/Group Description Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two. Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two. Total of all reporting groups
Overall Number of Baseline Participants 22 19 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
22
 100.0%
19
 100.0%
41
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants 19 participants 41 participants
47.7  (13.1) 46.1  (9.9) 46.9  (11.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants 19 participants 41 participants
Female
13
  59.1%
13
  68.4%
26
  63.4%
Male
9
  40.9%
6
  31.6%
15
  36.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants 19 participants 41 participants
22 19 41
1.Primary Outcome
Title Central Aortic Blood Pressure
Hide Description [Not Specified]
Time Frame Measured at baseline and 4 weeks.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carvedilol CR Atenolol
Hide Arm/Group Description:
Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.
Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
Overall Number of Participants Analyzed 22 19
Mean (Standard Error)
Unit of Measure: mmHg
-16.1  (10.4) -16.0  (18.7)
2.Secondary Outcome
Title Peripheral Blood Pressure
Hide Description [Not Specified]
Time Frame Measured at baseline, 2 weeks, and 4 weeks.
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carvedilol CR Atenolol
Hide Arm/Group Description Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two. Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
All-Cause Mortality
Carvedilol CR Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Carvedilol CR Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/19 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Carvedilol CR Atenolol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/22 (0.00%)   0/19 (0.00%) 
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: Dr. Benjamin J Epstein
Organization: University of Florida
Phone: 3523590945
EMail: epstein@cop.ufl.edu
Layout table for additonal information
Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00669279    
Other Study ID Numbers: 8COG11059
First Submitted: April 28, 2008
First Posted: April 30, 2008
Results First Submitted: December 5, 2011
Results First Posted: March 23, 2012
Last Update Posted: October 5, 2017