Impact of Nebivolol on Central Aortic Pressure

This study has been withdrawn prior to enrollment.

(Similar study already published)

Sponsor:

Information provided by:

Creighton University

ClinicalTrials.gov Identifier:

NCT01051947

First received: January 19, 2010

Last updated: July 29, 2011

Last verified: July 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 19, 2010

Last Updated Date

July 29, 2011

Start Date ^ICMJE

December 2009

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Stable blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Subjects will be randomized to nebivolol or metoprolol. Their medication will be titrated so that their blood pressure is within 10% of their initial reading.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01051947 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Impact of Nebivolol on Central Aortic Pressure

Official Title ^ICMJE

Impact of Nebivolol on Central Aortic Pressure

Brief Summary

A randomized, cross-over, single-blind study to compare the effects of nebivolol and metoprolol on central aortic pressure and peripheral brachial pressure in patients with stable cardiovascular disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Central Aortic Pressure

Intervention ^ICMJE

Drug: Nebivolol
10 mg by mouth daily for 2 weeks 20 mg by mouth daily for 2 weeks 40 mg by mouth daily for 2 weeks
Drug: Metoprolol
dosage prescribed prior to starting on study

Study Arm (s)

Experimental: Nebivolol
Nebivolol therapy for 2-6 weeks depending on blood pressure readings

Intervention: Drug: Nebivolol
Experimental: Metoprolol
Metoprolol therapy for 2-6 weeks depending on blood pressure readings

Intervention: Drug: Metoprolol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

May 2010

Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Subjects with history of hypertension
Subjects who have received metoprolol for a minimum of 3 months

Exclusion Criteria:

Patients who have had an acute myocardial infarction, coronary revascularization or who have been hospitalized for heart failure or cardiac arrhythmia in the past 6 months

Gender

Both

Ages

45 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01051947

Other Study ID Numbers ^ICMJE

08-15168

Has Data Monitoring Committee

Responsible Party

Jennifer Campbell, PharmD, Creighton University

Study Sponsor ^ICMJE

Creighton University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jennifer Campbell, PharmD

Creighton University

Information Provided By

Creighton University

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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