- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01051947
Impact of Nebivolol on Central Aortic Pressure
July 29, 2011 updated by: Creighton University
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
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Omaha, Nebraska, United States, 68131
- The Cardiac Center at Creighton University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
43 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nebivolol
Nebivolol therapy for 2-6 weeks depending on blood pressure readings
|
10 mg by mouth daily for 2 weeks 20 mg by mouth daily for 2 weeks 40 mg by mouth daily for 2 weeks
|
Experimental: Metoprolol
Metoprolol therapy for 2-6 weeks depending on blood pressure readings
|
dosage prescribed prior to starting on study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Stable blood pressure
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jennifer Campbell, PharmD, Creighton University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2009
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
January 19, 2010
First Submitted That Met QC Criteria
January 19, 2010
First Posted (Estimate)
January 20, 2010
Study Record Updates
Last Update Posted (Estimate)
August 1, 2011
Last Update Submitted That Met QC Criteria
July 29, 2011
Last Verified
July 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Vasodilator Agents
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Adrenergic beta-Agonists
- Sympatholytics
- Adrenergic beta-1 Receptor Antagonists
- Adrenergic beta-1 Receptor Agonists
- Nebivolol
- Metoprolol
Other Study ID Numbers
- 08-15168
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Forest LaboratoriesCompletedHypertensionUnited States
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