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Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00123604
Recruitment Status : Completed
First Posted : July 25, 2005
Results First Posted : November 18, 2014
Last Update Posted : November 18, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aaron S. Kelly, Ph.D., St. Paul Heart Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions Hypertension
Type 2 Diabetes Mellitus
Interventions Drug: Carvedilol
Drug: Metoprolol
Enrollment 36
Recruitment Details Recruitment occured at medical clinics.
Pre-assignment Details  
Arm/Group Title Metoprolol Carvedilol
Hide Arm/Group Description Metoprolol, orally, 200 mg, once daily Carvedilol, orally, 25 mg, once daily
Period Title: Overall Study
Started 19 17
Completed 18 16
Not Completed 1 1
Arm/Group Title Metoprolol Carvedilol Total
Hide Arm/Group Description Metoprolol, orally, 200mg, twice daily for five months Carvedilol, orally, 25mg, twice daily for five months Total of all reporting groups
Overall Number of Baseline Participants 19 17 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
18
  94.7%
16
  94.1%
34
  94.4%
>=65 years
1
   5.3%
1
   5.9%
2
   5.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 17 participants 36 participants
61.9  (9.9) 60.9  (8.5) 61.4  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 17 participants 36 participants
Female
6
  31.6%
4
  23.5%
10
  27.8%
Male
13
  68.4%
13
  76.5%
26
  72.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 17 participants 36 participants
19 17 36
1.Primary Outcome
Title Flow Mediated Dilation
Hide Description Flow mediated dilation is a measure of endothelial function. It is measured by the percent change in artery diameter (i.e. dilation), pre and post manual artery occlusion.
Time Frame change from baseline to 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carvedilol Metoprolol
Hide Arm/Group Description:
Carvedilol, orally, 25mg, once daily
Metoprolol, orally, 200mg, once daily
Overall Number of Participants Analyzed 16 18
Mean (Standard Deviation)
Unit of Measure: percentage of change in dilation
6.2  (3.9) 4.1  (3.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Metoprolol Carvedilol
Hide Arm/Group Description Metoprolol, orally, 200mg, once daily Carvedilol, orally, 25 mg, once daily
All-Cause Mortality
Metoprolol Carvedilol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Metoprolol Carvedilol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Metoprolol Carvedilol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/17 (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: Aaron S. Kelly, Ph.D.
Organization: University of Minnesota
Phone: 612-626-3492
EMail: kelly105@umn.edu
Layout table for additonal information
Responsible Party: Aaron S. Kelly, Ph.D., St. Paul Heart Clinic
ClinicalTrials.gov Identifier: NCT00123604     History of Changes
Other Study ID Numbers: GSK101598
First Submitted: July 21, 2005
First Posted: July 25, 2005
Results First Submitted: June 29, 2012
Results First Posted: November 18, 2014
Last Update Posted: November 18, 2014