PrehypertensionPhase 2NCT02998840
A Prospective Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure
A Phase 2 study testing B244 in people with Prehypertension and Hypertension, Stage I, run by AOBiome LLC at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prehypertension, Hypertension, Stage I
- What is being tested?
- B244
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 10 sitesUnited States
- Study dates
- Nov 2016to 26 Jun 2017
- Phase
- Phase 2
- 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
- Male and female subjects ≥18 years of age
- In good general health as determined by a thorough medical history and physical examination, and vital signs
- Clinical diagnosis of elevated Blood Pressure defined as:
- Having systolic prehypertension measurements having systolic BP (mmHg) of 120-139 and Diastolic BP (mmHg) of 90
- OR
- Having systolic Stage 1 hypertension measurements having systolic BP (mmHg) of 140-159 and Diastolic BP (mmHg) of 100
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- Hypertension treatment naïve patients, defined as those patients who have never been treated with antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer.
- Willing to refrain from using any antihypertensive treatments, other than the investigational product, including herbal supplements, systemic use of steroids, chronic use of NSAIDS, any antihypertensive agents, such as beta-blockers, diuretics, ACE inhibitors, CA channel blockers, Alpha blockers, Central Acting agents and vasodilators.
- Ability to comprehend and comply with procedures
- Agree to commit to participate in the current protocol
- Provide written informed consent prior to any study procedure being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read)
Who cannot join
- Pregnant and/or lactating women
- Patients on treatment for Benign Prostatic Hyperplasia (BPH)
- Clinically significant history of cardiovascular disease (i. e. PCI, CABG MI (if event occurred 12 months), atrial fibrillation, frequent PAC, cardiac rhythm disorder, syncope, valve repair/replacement, heart transplantation, PTA, peripheral bypass surgery, endarterectomy, unstable angina, TIA, stroke and NYHF category II, II and IV heart failure.
- Patients with renal failure, significant kidney or renal disease defined as having creatinine level of mg/dL
- Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient's successful participation for the duration of the study
- History of migraines and/or anxiety, where patient is unable to refrain from the use of beta blockers
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- History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
- The participant has been previously randomized in this study
- Subjects with clinical diagnosis of Type I Diabetes
- Subjects with arm circumference of 42 cm
- Any condition that would prevent the subject from participating in the trial in the opinion of the evaluation physician
- The participant has received an investigational product within 30 days prior to randomization
- Prior use of any product containing B244 or Nitrosomonas eutropha
- Unable to lie flat or sit for 15 minutes
- Concurrent participation in other trials
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Central Research Associates
Birmingham, Alabama, 35205
ICCT Research International
Chicago, Illinois, 60611
AGA Clinical Trials
Hialeah, Florida, 33012
Research Trials WorldWide
Humble, Texas, 77338
MedPharmics
Metairie, Louisiana, 70006
Clinical Research Consulting
Milford, Connecticut, 06460
Elite Clinical Studies
Phoenix, Arizona, 85018
Alternative Primary Care (Einstein Clinical Research)
Silver Spring, Maryland, 20190
CHEAR Center
The Bronx, New York, 10459
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure
The purpose of this study is to evaluate and compare the efficacy of B244 in treating patients with hypertension.
Read the detailed description
This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle application on BP and inflammatory biomarkers.
- Conditions
- Prehypertension, Hypertension, Stage I
- Being tested
- B244, Vehicle
- Keywords
- elevated blood pressure
- Medical subject headings
- Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B244Biological
odorless suspension
VehicleBiological
odorless suspension
| Study group | Role | What they receive |
|---|---|---|
| B244 4 pumps applied to the face | Active comparator | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. Receives: Biological: B244 |
| B 244 8 Pumps applied to face and torso | Active comparator | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. Receives: Biological: B244 |
| Vehicle 4 pumps applied to the face | Sham comparator | 4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. Receives: Biological: Vehicle |
| Vehicle 8 pumps applied to face and torso | Sham comparator | 8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. Receives: Biological: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Measured: Baseline-6 weeks
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Measured: Baseline-Week 4
Secondary outcomes (2)
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
Clinical diastolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
Measured: Baseline-Week 4
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
An ambulatory blood pressure measurement (ABPM) device was placed on a subject's arm during the clinic visit to record 24-hour blood pressure and heart rate measurements.
Measured: Baseline-Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion25 Apr 2017
- Study completion26 Jun 2017
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 PrehypertensionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- AOBiome LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Responsible party
- Sponsor
- Investigators
- Larry Weiss, MD, Study director, Chief Medical Officer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02998840
- Sponsor's protocol ID
- AVB244-003
- Status last verified
- Aug 2022
- First submitted
- 22 Nov 2016
- Last updated
- 15 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized, Phase II Study of B244 Delivered as a Topical Spray to Determine Safety and Efficacy in Subjects With Elevated Blood Pressure
- ClinicalTrials.gov ID
- NCT02998840
- Acronym / sponsor ID
- AVB244-003
- Conditions
- Prehypertension, Hypertension, Stage I
- Keywords
- elevated blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- AOBiome LLCIndustry (pharma, biotech, devices)
- Collaborators
- Veristat, Inc.
- Study start
- Nov 2016 (actual)
- Primary completion
- 25 Apr 2017 (actual)
- Study completion
- 26 Jun 2017 (actual)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Posted 15 Aug 2022
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 evaluate and compare the efficacy of B244 in treating patients with hypertension.
Detailed description
This is a Prospective, Vehicle Controlled, Double Blinded, Multicenter, Randomized Phase II trial, comparing the effect of twice daily B244 application for 4 weeks vs vehicle application on BP and inflammatory biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| B244 4 pumps applied to the face | Active comparator | Biological: B2444 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. |
| B 244 8 Pumps applied to face and torso | Active comparator | Biological: B2448 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. |
| Vehicle 4 pumps applied to the face | Sham comparator | Biological: Vehicle4 pumps total of spray to saturate the entire face. Applications should occur in the morning and at night for 4 weeks. |
| Vehicle 8 pumps applied to face and torso | Sham comparator | Biological: Vehicle8 pumps total - 4 pumps of spray to saturate the entire face and 4 pumps to the torso Applications should occur in the morning and at night for 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male and female subjects ≥18 years of age
- In good general health as determined by a thorough medical history and physical examination, and vital signs
- Clinical diagnosis of elevated Blood Pressure defined as:
- Hypertension treatment naïve patients, defined as those patients who have never been treated with antihypertensive medications or have been off any hypertensive treatment for a period of 12 weeks or longer.
- Willing to refrain from using any antihypertensive treatments, other than the investigational product, including herbal supplements, systemic use of steroids, chronic use of NSAIDS, any antihypertensive agents, such as beta-blockers, diuretics, ACE inhibitors, CA channel blockers, Alpha blockers, Central Acting agents and vasodilators.
Key exclusion criteria (15 listed)
- Pregnant and/or lactating women
- Patients on treatment for Benign Prostatic Hyperplasia (BPH)
- Clinically significant history of cardiovascular disease (i. e. PCI, CABG MI (if event occurred 12 months), atrial fibrillation, frequent PAC, cardiac rhythm disorder, syncope, valve repair/replacement, heart transplantation, PTA, peripheral bypass surgery, endarterectomy, unstable angina, TIA, stroke and NYHF category II, II and IV heart failure.
- Patients with renal failure, significant kidney or renal disease defined as having creatinine level of mg/dL
- Presence of any condition (medical, psychological, social, or geographical), actual or anticipated, that the Investigator feels would restrict or limit the patient's successful participation for the duration of the study
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 |
|---|---|---|
| B244odorless suspension | Biological | B 244 8 Pumps applied to face and torso, B244 4 pumps applied to the face |
| Vehicleodorless suspension | Biological | Vehicle 4 pumps applied to the face, Vehicle 8 pumps applied to face and torso |
Primary outcome
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Baseline-6 weeks
Safety and tolerability endpoints will consist of all treatment related adverse events reporting during the study duration.
Difference in Mean in Clinic Systolic BP Between the Active and Vehicle Groups
Time frame: Baseline-Week 4
Clinical systolic blood pressure (BP) readings were obtained at every visit using a calibrated electronic sphygmomanometer. Three measurements were taken at each visit. The average of the second and third readings was documented. Data was analyzed using mixed-effects model repeated measures (MMRM). Difference was calculated as the change from Baseline to Day 28.
2 secondary outcomes
Difference in Mean in Clinic Diastolic BP Between the Active and Vehicle Group
Time frame: Baseline-Week 4
Difference in Mean Ambulatory Systolic and Diastolic Daytime Blood Pressure
Time frame: Baseline-Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Larry Weiss, MD study director
Chief Medical Officer
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing B244 in people with Prehypertension and Hypertension, Stage I, run by AOBiome LLC at 10 sites 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 11 inclusion and 15 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 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Aug 2022). 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?
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 (time frame: Baseline-6 weeks). The study lists 2 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 15 Sep 2022.