Pre-hypertensionPhase 4NCT01202175
Effects of the Beta-blocker Nebivolol (Bystolic) on Subjects With High Normal Blood Pressure and/or a Family History of Hypertension
A Phase 4 study testing Nebivolol in people with Pre-hypertension and Hypertension, run by University of California, San Diego at 1 site in United States.
Trial summary
The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Pre-hypertension, Hypertension
- What is being tested?
- Nebivolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Jun 2013
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Prehypertensive male and female subjects with SBP =120-139 or DBP =80-89 with at least one known family member (must be diagnosed prior to the age of 60) with essential hypertension (confirmation may be sought).
- All ethnicities
- Non-smokers and non-drug abusers, no current smoking or illicit drug use in the prior 3 months.
- Aged 18-40 years
- No known serious medical conditions requiring close monitoring from physicians- such as liver impairment, chronic kidney disease, or diabetes mellitus
- Subjects will need to remain in the San Diego area for the duration of the study (10 weeks) and be accessible by telephone or email.
- Female subjects must be willing to use a birth control method, such as abstinence, birth control pills, diaphragm, condom, or intrauterine device to prevent pregnancy during the study.
Who cannot join
- Subjects with SBP >140 or SBP<120 or DBP >90 and DBP<80
- We will exclude subjects whose family members have known secondary etiologies for hypertension such as hyperaldosteronism or Cushing's Disease.
- Subjects cannot have a chronic medical condition that is actively treated by a physician, such as liver impairment, diabetes, or kidney disease
- History of bronchial asthma or chronic obstructive pulmonary disease
- Subjects cannot be on any anti-hypertensive medications for any reason.
- Subjects may not have previous intolerance, hypersensitivity, or allergy to any beta blocker therapy or may have contraindications to beta blocker therapy such as asthma, bradycardia, etc.
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- Subjects may not be taking medications which may affect the metabolism of nebivolol, such as those that inhibit CYP2D6 (such as fluoxetine or cimetidine)
- Nursing women, pregnant women, or those that plan to become pregnant in the study period will also be excluded. (Pregnancy tests will be performed on all female subjects at the start of the study)
- Subjects with pulse rate consistently <60 beats per minute or evidence of arrythmias including atrioventricular block.
- Those that have smoked or used illicit drugs within the past 3 months
- Female subjects that are not willing to use a birth control method, such as abstinence, birth control pills, diaphragm, condom, or intrauterine device to prevent pregnancy during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
La Jolla, California, 92093
About this study
Official title: Effects of the Novel Beta-adrenergic Antagonist Nebivolol (Bystolic) on Prehypertensive Subjects at Genetic Risk of Hypertension: Implications for Inflammation, Endothelial Dysfunction, and Oxidative Stress.
The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to investigate whether these subjects have the same markers (such as microscopic protein in the urine or C-reactive protein in the blood) in the blood and urine that people with high blood pressure have, and whether they are improved before and after taking the beta-blocker nebivolol.
- Conditions
- Pre-hypertension, Hypertension
- Being tested
- Nebivolol
- Keywords
- Genetic risk of hypertension
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NebivololDrug
Also called Bystolic
Oral nebivolol 2.5-5mg once daily
| Study group | Role | What they receive |
|---|---|---|
| Nebivolol | Experimental | Not described Receives: Drug: Nebivolol |
| Sugar pill | Placebo comparator | Not described Receives: Drug: Nebivolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aortic Systolic Blood Pressure (SBP)
Measured: Basline (visit 1) and 8 weeks (visit 2)
Aortic Diastolic Blood Pressure (DBP)
Measured: Basline (visit 1) and 8 weeks (visit 2)
Aortic Mean Arterial Pressure (MAP)
Measured: Basline (visit 1) and 8 weeks (visit 2)
Aortic Pulse Pressure
Measured: Basline (visit 1) and 8 weeks (visit 2)
Aortic Augmentation Pressure
Measured: Basline (visit 1) and 8 weeks (visit 2)
Aortic Augmentation Index for Heart Rate
Measured: Basline (visit 1) and 8 weeks (visit 2)
Pulse Wave Velocity
Measured: Basline (visit 1) and 8 weeks (visit 2)
Heart Rate, Beats Per a Minute
Measured: Basline (visit 1) and 8 weeks (visit 2)
Secondary outcomes (4)
Urinary Nitric Oxide Excretion
Measured: Basline (visit 1) and 8 weeks (visit 2)
Urinary Isoprostane Excretion
Measured: Basline (visit 1) and 8 weeks (visit 2)
Urinary Hydrogen Peroxide Excretion
Measured: Baseline (visit 1) and 8 Weeks (visit 2)
Plasma Interleukin Levels
Measured: Basline (visit 1) and 8 weeks (visit 2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2010 (estimated)
- Study startJul 2010
- Primary completionJun 2012
- Study completionJun 2013
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 Pre-hypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- Forest Laboratories
- Responsible party
- Principal investigator, Joachim H. Ix, University of California, San Diego
- Investigators
- Daniel O'Connor, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01202175
- Sponsor's protocol ID
- 100353
- Status last verified
- Jul 2019
- First submitted
- 24 Jun 2010
- Last updated
- 21 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Novel Beta-adrenergic Antagonist Nebivolol (Bystolic) on Prehypertensive Subjects at Genetic Risk of Hypertension: Implications for Inflammation, Endothelial Dysfunction, and Oxidative Stress.
- ClinicalTrials.gov ID
- NCT01202175
- Acronym / sponsor ID
- 100353
- Conditions
- Pre-hypertension, Hypertension
- Keywords
- Genetic risk of hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- Forest Laboratories
- Study start
- Jul 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 15 Sep 2010 (estimated)
- Results
- Posted 21 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to evaluate subjects at high risk of future development of hypertension, those with a family history of hypertension and/or that already have high normal(SBP 120-139 mmHg or DBP 80-89 mmHg) blood pressure. The investigators plan to investigate whether these subjects have the same markers (such as microscopic protein in the urine or C-reactive protein in the blood) in the blood and urine that people with high blood pressure have, and whether they are improved before and after taking the beta-blocker nebivolol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nebivolol | Experimental | Drug: Nebivolol |
| Sugar pill | Placebo comparator | Drug: Nebivolol |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- • Prehypertensive male and female subjects with SBP =120-139 or DBP =80-89 with at least one known family member (must be diagnosed prior to the age of 60) with essential hypertension (confirmation may be sought).
Key exclusion criteria (11 listed)
- Subjects with SBP >140 or SBP<120 or DBP >90 and DBP<80
- We will exclude subjects whose family members have known secondary etiologies for hypertension such as hyperaldosteronism or Cushing's Disease.
- Subjects cannot have a chronic medical condition that is actively treated by a physician, such as liver impairment, diabetes, or kidney disease
- History of bronchial asthma or chronic obstructive pulmonary disease
- Subjects cannot be on any anti-hypertensive medications for any reason.
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: BystolicOral nebivolol 2.5-5mg once daily | Drug | Nebivolol, Sugar pill |
Primary outcome
Aortic Systolic Blood Pressure (SBP)
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Aortic Diastolic Blood Pressure (DBP)
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Aortic Mean Arterial Pressure (MAP)
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Aortic Pulse Pressure
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Aortic Augmentation Pressure
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Aortic Augmentation Index for Heart Rate
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Pulse Wave Velocity
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Heart Rate, Beats Per a Minute
Time frame: Basline (visit 1) and 8 weeks (visit 2)
4 secondary outcomes
Urinary Nitric Oxide Excretion
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Urinary Isoprostane Excretion
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Urinary Hydrogen Peroxide Excretion
Time frame: Baseline (visit 1) and 8 Weeks (visit 2)
Plasma Interleukin Levels
Time frame: Basline (visit 1) and 8 weeks (visit 2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
- 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.
Daniel O'Connor, MD principal investigator
University of California, San Diego
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 Pre-hypertension and Hypertension, run by University of California, San Diego 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 21 Aug 2019. 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. Some participants in this study may receive a placebo. 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 21 Aug 2019). 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?
Aortic Systolic Blood Pressure (SBP) (time frame: Basline (visit 1) and 8 weeks (visit 2)). The study lists 8 primary outcomes in all. 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 21 Aug 2019.