Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate

• Sponsor: University of Mississippi Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00849810
• Collaborator: (none)
• Enrollment: 1
• Location: 1
• Arm: 1
• Duration (Months): 22
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

The purpose of the study is to compare the effects of nebivolol and metoprolol on 24-hour ambulatory blood pressure characteristics and basal metabolic rates in patients with hypertension.

Condition or Disease	Intervention/Treatment	Phase
Hypertension	Drug: Metoprolol; Drug: Nebivolol	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study
• Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Metoprolol to nebivolol metoprolol 25-200mg at a stable daily dose for 4 weeks, then change to nebivolol at a comparable stable dose (5-20 mg) for 4 -5 weeks.	Drug: Metoprolol; Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks; Other Names: Nebivolol is bystolic Metoprolol is lopressor ; Drug: Nebivolol; 5 - 20 mg daily, at a stable dose for 4 to 5 weeks

Outcome Measures

Primary Outcome Measures

1. Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. [4 weeks (pre- and post-treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years old or older

• currently be treated at a University of MS Medical Center Internal Medicine Clinics

• currently taking metoprolol succinate for hypertension

• have their hypertension controlled (<140/90).

Exclusion Criteria:

• uncontrolled hypertension

• severe renal or moderate hepatic impairment

• currently taking CYP 2D6 inducers/inhibitors

• recent stroke (less than 6 months)

• recent myocardial infarction (less than 6 months)

• congestive heart failure

• diagnosed obstructive sleep apnea

• atrial fibrillation

• arm circumference >50 cm

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216

Sponsors and Collaborators

• University of Mississippi Medical Center

Investigators

• Principal Investigator: Deborah Minor, PharmD, University of Mississippi Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah Minor, Professor of Medicine, University of Mississippi Medical Center
• ClinicalTrials.gov Identifier: NCT00849810
• Other Study ID Numbers: 2009-0002
• First Posted: Feb 24, 2009
• Last Update Posted: Mar 19, 2013
• Last Verified: Mar 1, 2013

• Keywords provided by Deborah Minor, Professor of Medicine, University of Mississippi Medical Center: Hypertension; Beta-blockers; Ambulatory blood pressure; Basal metabolic rate; Quality of life
• Additional relevant MeSH terms: Hypertension; Metoprolol; Nebivolol

Study Results

Participant Flow

Recruitment Details	From 11/2008-4/2009, 472 patient were prescribed metoprolol succinate. During screening, metoprolol succinate was discontinued in 87 patients and 177 were excluded (obstacles to visits, competency issues). A national shortage of metoprolol succinate caused discontinuation in mant patients. One patient was enrolled and completed the study.

Arm/Group Title	Metoprolol to Nebivolol
Arm/Group Description	Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg.
Period Title: Overall Study
STARTED	1
COMPLETED	1
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Metoprolol to Nebivolol
Arm/Group Description	Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg.
Overall Participants	1
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	1 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	1 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	1 100%

Outcome Measures

1. Primary Outcome

Title	Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.
Time Frame	4 weeks (pre- and post-treatment)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metoprolol to Nebivolol
Arm/Group Description	Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg.
Measure Participants	1
SBP ABPM on metoprolol	122
DBP ABPM on metoprolol	72
SBP ABPM on nebivolol	122
DBP ABPM on nebivolol	71

Adverse Events

Arm/Group Title	Metoprolol to Nebivolol
Arm/Group Description	Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose. Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg.
All Cause Mortality
	Metoprolol to Nebivolol
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Metoprolol to Nebivolol
	Affected / at Risk (%)	# Events
Total	0/1 (0%)
Other (Not Including Serious) Adverse Events
	Metoprolol to Nebivolol
	Affected / at Risk (%)	# Events
Total	0/1 (0%)

Limitations/Caveats

[Not Specified]

More Information

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.