Trial Outcomes & Findings for Vascular Effects of Carvedilol Versus Metoprolol in Hypertensive Patients With Type 2 Diabetes (NCT NCT00123604)

Last Updated: 2014-11-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

change from baseline to 5 months

Results posted on

2014-11-18

Participant Flow

Recruitment occured at medical clinics.

Participant milestones

Participant milestones
Measure	Metoprolol Metoprolol, orally, 200 mg, once daily	Carvedilol Carvedilol, orally, 25 mg, once daily
Overall Study STARTED	19	17
Overall Study COMPLETED	18	16
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoprolol n=19 Participants Metoprolol, orally, 200mg, twice daily for five months	Carvedilol n=17 Participants Carvedilol, orally, 25mg, twice daily for five months	Total n=36 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants	16 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	61.9 years STANDARD_DEVIATION 9.9 • n=5 Participants	60.9 years STANDARD_DEVIATION 8.5 • n=7 Participants	61.4 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants	17 participants n=7 Participants	36 participants n=5 Participants

PRIMARY outcome

Timeframe: change from baseline to 5 months

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.

Outcome measures

Outcome measures
Measure	Carvedilol n=16 Participants Carvedilol, orally, 25mg, once daily	Metoprolol n=18 Participants Metoprolol, orally, 200mg, once daily
Flow Mediated Dilation	6.2 percentage of change in dilation Standard Deviation 3.9	4.1 percentage of change in dilation Standard Deviation 3.4

Adverse Events

Metoprolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Carvedilol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Aaron S. Kelly, Ph.D.

University of Minnesota

Phone: 612-626-3492

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place