HypertensionPhase 4NCT01206439
An Advanced Echocardiographic Evaluation of Nebivolol
A Phase 4 study testing nebivolol in people with Hypertension, run by Jack Rubinstein at 1 site in United States.
Trial summary
The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Hypertension
- What is being tested?
- nebivolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2012
- Phase
- Phase 4
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of hypertension
- Written informed consent before initiation of any study related procedure
- Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy.
- Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.
Who cannot join
- Physical limitations resulting in a limited ability to walk on treadmill for stress echo
- Intolerance to beta blockers
- On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
- Currently pregnant or breast feeding.
- LFT > 3 X ULN
- HgA1C > 7
Show all 12Show fewer
- Participation in other clinical research studies involving the evaluation of other investigational drugs or devices within past 30 days of enrollment
- Unwilling to follow protocol or return for study related procedures.
- Any of the following conditions:
- Coronary artery disease Heart failure Valvular heart disease Ischemic heart disease Atrial fibrillation Pacemaker ICD Hyperlipidemia Diabetes Mellitus Stroke/TIA Anemia COPD Asthma Renal failure requiring dialysis Liver failure Cirrhosis Thyroid dysfunction
- Any other medical condition that in the PI's opinion could affect myocardial function.
- Current ETOH or illicit drug abuse -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.
Read the detailed description
Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.
- Conditions
- Hypertension
- Being tested
- nebivolol
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nebivololDrug
Also called Bystolic
nebivolol 5 or 10 mg oral, daily
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol 5 or 10 mg, oral, daily | Experimental | Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. Receives: Drug: nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic and Diastolic Myocardial Function
Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.
Measured: Baseline to day 180
Secondary outcomes (1)
Exercise Tolerance
Changes in exercise tolerance and time from baseline to 180 days.
Measured: Baseline to day 180.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Slow enrollment
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jack Rubinstein
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Sponsor-investigator, Jack Rubinstein, University of Cincinnati
- Investigators
- Jack Rubinstein, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01206439
- Sponsor's protocol ID
- UC- 09-12-31-04
- Status last verified
- Feb 2018
- First submitted
- 2 Apr 2010
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Advanced Echocardiographic Evaluation of Nebivolol
- ClinicalTrials.gov ID
- NCT01206439
- Acronym / sponsor ID
- UC- 09-12-31-04
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Jack RubinsteinUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Sep 2010 (estimated)
- Results
- Posted 25 Nov 2015
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 this study is to determine if Nebivolol has any effect on heart function determined by changes in echocardiographic data or exercise tolerance.
Detailed description
Subjects will be given either 5 or 10 mg daily of oral Nebivolol for blood pressure control. They will undergo stress echocardiography at baseline, day 14, 90 and 180.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nebivolol 5 or 10 mg, oral, daily | Experimental | Drug: nebivololSubject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of hypertension
- Written informed consent before initiation of any study related procedure
- Baseline Blood pressure > 140 systolic or >90 diastolic if on no antihypertensive therapy.
- Currently taking one antihypertensive or one antihypertensive and one diuretic for the treatment of hypertension.
Key exclusion criteria (12 listed)
- Physical limitations resulting in a limited ability to walk on treadmill for stress echo
- Intolerance to beta blockers
- On more than one medication for the treatment of hypertension unless the second medication is a diuretic.
- Currently pregnant or breast feeding.
- LFT > 3 X ULN
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 |
|---|---|---|
| nebivololAlso: Bystolicnebivolol 5 or 10 mg oral, daily | Drug | Nebivolol 5 or 10 mg, oral, daily |
Primary outcome
Change in Systolic and Diastolic Myocardial Function
Time frame: Baseline to day 180
Cannot report as only 1 patient was evaluated and data will not be able to remain anonymous.
1 secondary outcome
Exercise Tolerance
Time frame: Baseline to day 180.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- 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.
Jack Rubinstein, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing nebivolol in people with Hypertension, run by Jack Rubinstein 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 12 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 15 Feb 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2015). 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?
Change in Systolic and Diastolic Myocardial Function (time frame: Baseline to day 180). 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 15 Feb 2018.