A Phase 4 interventional study of Carvedilol CR and Atenolol in Hypertension, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-10-05.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
The purpose of this research study is to determine whether atenolol or controlled release carvedilol lower blood pressure in the body as effectively as in the arm. Blood pressure measured in the aorta, a large blood vessel carrying blood away from the heart, may be a better measure of the harmful effects of high blood pressure on the body's organs. In the past, blood pressure has only been measured in the arms. However, blood pressure in the arms may not accurately reflect the blood pressure in the aorta and thus may mislead doctors treating high blood pressure. For this reason, we are testing whether two different medications for blood pressure, both in a class called beta blockers, have similar effects on blood pressure in the arm and aorta.
Carvedilol reduces aortic wave reflection and improves left ventricular/vascular coupling: a comparison with atenolol (CENTRAL Study) is a prospective, open-label, comparative, randomized control trial that evaluated brachial and central hemodynamic profiles in patients taking atenolol or controlled-release carvedilol.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 41 is below the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Carvedilol CR
Drug: Atenolol
Dose titration of 20mg by mouth once daily for 1 week, then 40mg by mouth once daily for 1 week, then 80mg by mouth once daily for 2 weeks
Also known as: Coreg CR
Dose titration of 25mg by mouth once daily for 1 week, then 50mg by mouth once daily for 1 week, then 100mg by mouth once daily for 2 weeks
Also known as: Tenormin
Central Aortic Blood Pressure
Time frame: Measured at baseline and 4 weeks.
Peripheral Blood Pressure
Time frame: Measured at baseline, 2 weeks, and 4 weeks.
| Milestone | Carvedilol CR | Atenolol |
|---|---|---|
| Started | 22 | 19 |
| Completed | 22 | 19 |
| Not completed | 0 | 0 |
| mmHg | Carvedilol CR | Atenolol |
|---|---|---|
| Central Aortic Blood Pressure | -16.1 ± 10.4 | -16.0 ± 18.7 |
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Carvedilol CR | — | 0/22 (0%) | 0/22 (0%) |
| Atenolol | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Carvedilol CR | Atenolol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 22 | 19 | 41 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Carvedilol CR | Atenolol | Total |
|---|---|---|---|
| Mean | 47.7 ± 13.1 | 46.1 ± 9.9 | 46.9 ± 11.5 |
| Sex: Female, Male(Participants) | Carvedilol CR | Atenolol | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 9 | 6 | 15 |
| Region of Enrollment(participants) | Carvedilol CR | Atenolol | Total |
|---|---|---|---|
| United States | 22 | 19 | 41 |
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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