Trial Outcomes & Findings for Effect of Carvedilol Controlled-Release (CR) and Atenolol on Central Blood Pressure (NCT NCT00669279)

NCT ID: NCT00669279

Last Updated: 2017-10-05

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: Measured at baseline and 4 weeks.
• Results posted on: 2017-10-05

Participant Flow

Participant milestones

Measure	Carvedilol CR Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.	Atenolol Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
Overall Study STARTED	22	19
Overall Study COMPLETED	22	19
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Carvedilol CR n=22 Participants Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.	Atenolol n=19 Participants Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.	Total n=41 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	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	47.7 years STANDARD_DEVIATION 13.1 • n=5 Participants	46.1 years STANDARD_DEVIATION 9.9 • n=7 Participants	46.9 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	19 participants n=7 Participants	41 participants n=5 Participants

PRIMARY outcome

Timeframe: Measured at baseline and 4 weeks.

Outcome measures

Measure	Carvedilol CR n=22 Participants Controlled-release carvedilol 20 mg - Forced titration occurred in carvedilol to 40 mg at week one, and to 80 mg at week two.	Atenolol n=19 Participants Atenolol 25 mg once daily - Forced titration occurred in atenolol to 50 mg at week one, and to 100 mg at week two.
Central Aortic Blood Pressure	-16.1 mmHg Standard Error 10.4	-16.0 mmHg Standard Error 18.7

SECONDARY outcome

Timeframe: Measured at baseline, 2 weeks, and 4 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Carvedilol CR

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Atenolol

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

Dr. Benjamin J Epstein

University of Florida

Phone: 3523590945

Email: epstein@cop.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place