HypertensionNCT00849810
Comparing the Effects of Two Beta Blockers,Metoprolol and Nebivolol,on Ambulatory Blood Pressure and Basal Metabolic Rate
A study testing Metoprolol and Nebivolol in people with Hypertension, run by University of Mississippi Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Metoprolol and Nebivolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- diagnosed obstructive sleep apnea
- atrial fibrillation
- arm circumference >50 cm
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center
Jackson, Mississippi, 39216
About this study
Official title: Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study
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.
- Conditions
- Hypertension
- Being tested
- Metoprolol, Nebivolol
- Keywords
- Hypertension, Beta-blockers, Ambulatory blood pressure, Basal metabolic rate, Quality of life
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called Nebivolol is bystolic, Metoprolol is lopressor
Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks
NebivololDrug
5 - 20 mg daily, at a stable dose for 4 to 5 weeks
| Study group | Role | What they receive |
|---|---|---|
| Metoprolol to nebivolol | Experimental | 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. Receives: Drug: Metoprolol; Drug: Nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.
Measured: 4 weeks (pre- and post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Difficulty with recruiting willing participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Minor, University of Mississippi Medical Center
- Investigators
- Deborah Minor, PharmD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00849810
- Sponsor's protocol ID
- 2009-0002
- Status last verified
- Mar 2013
- First submitted
- 2 Feb 2009
- Last updated
- 19 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Nebivolol Versus Metoprolol on 24-hour Blood Pressures and Basal Metabolic Rate: An Open-Label Study
- ClinicalTrials.gov ID
- NCT00849810
- Acronym / sponsor ID
- 2009-0002
- Conditions
- Hypertension
- Keywords
- Hypertension, Beta-blockers, Ambulatory blood pressure, Basal metabolic rate, Quality of life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruiting willing participants.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 24 Feb 2009 (estimated)
- Results
- Posted 19 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metoprolol to nebivolol | Experimental | Drug: Metoprolol, Drug: Nebivololmetoprolol 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoprololAlso: Nebivolol is bystolic, Metoprolol is lopressorMetoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks | Drug | Metoprolol to nebivolol |
| Nebivolol5 - 20 mg daily, at a stable dose for 4 to 5 weeks | Drug | Metoprolol to nebivolol |
Primary outcome
Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure.
Time frame: 4 weeks (pre- and post-treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Minor, PharmD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoprolol and Nebivolol in people with Hypertension, run by University of Mississippi Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome is Pre- and Post-treatment Ambulatory Blood Pressure. (time frame: 4 weeks (pre- and post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2013.