PrehypertensionPhase 1/2NCT01937754
Study of the Effects of an Oral Nitric Oxide Supplement on Blood Pressure in Prehypertensive Adults
A Phase 1/2 study testing Nitric Oxide supplement in people with Prehypertension, run by Neogenis Laboratories at 1 site in United States.
Trial summary
Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Prehypertension
- What is being tested?
- Nitric Oxide supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Sep 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults between the ages of 18 to 80 years
- Two blood pressure readings of >/=135/80 mmHg at rest, thus representing prehypertension
- Informed consent
Who cannot join
- Existence of any significant internal or cardiovascular disease;
- Current use of any antihypertensive medication.
- Inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.
Trial locations and contacts
1 site in 1 country.
United States1 site
California Medical Institute
Beverly Hills, California, 90211
About this study
Official title: Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.
- Conditions
- Prehypertension
- Being tested
- Nitric Oxide supplement, Placebo
- Keywords
- Prehypertension, Nitric Oxide, Blood Pressure, Functional Capacity, Quality of Life
- Medical subject headings
- Prehypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide supplementDietary supplement
Also called Neo40 Daily
Lozenge consisting of beetroot and 75 mg caffeine
PlaceboDietary supplement
Same form factor and flavor as test lozenge but contains no active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide supplement | Active comparator | Not described Receives: Dietary Supplement: Nitric Oxide supplement |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in Systolic and Diastolic Blood Pressure Readings
Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment.
Measured: 30 days
Secondary outcomes (1)
Improvement in Functional Capacity
Participant will take a six minute walk test at baseline and again after thirty days during the follow-up appointment. Achieved distances will be measured and recorded.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startJan 2013
- Primary completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neogenis Laboratories
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ernst Schwarz, Neogenis Laboratories
- Investigators
- Ernst Schwarz, MD, PhD, Principal investigator, California Medical Institute, Cedars Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937754
- Sponsor's protocol ID
- Neo-4085
- Status last verified
- Sep 2013
- First submitted
- 29 Aug 2013
- Last updated
- 10 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
- ClinicalTrials.gov ID
- NCT01937754
- Acronym / sponsor ID
- Neo-4085
- Conditions
- Prehypertension
- Keywords
- Prehypertension, Nitric Oxide, Blood Pressure, Functional Capacity, Quality of Life
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Neogenis LaboratoriesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2013 (estimated)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide supplement | Active comparator | Dietary Supplement: Nitric Oxide supplement |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between the ages of 18 to 80 years
- Two blood pressure readings of >/=135/80 mmHg at rest, thus representing prehypertension
- Informed consent
Key exclusion criteria (3 listed)
- Existence of any significant internal or cardiovascular disease;
- Current use of any antihypertensive medication.
- Inability to give informed consent, or fill out standard questionnaires or inability to follow up clinically.
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 |
|---|---|---|
| Nitric Oxide supplementAlso: Neo40 DailyLozenge consisting of beetroot and 75 mg caffeine | Dietary supplement | Nitric Oxide supplement |
| PlaceboSame form factor and flavor as test lozenge but contains no active ingredients | Dietary supplement | Placebo |
Primary outcome
Reduction in Systolic and Diastolic Blood Pressure Readings
Time frame: 30 days
Two blood pressure readings at rest will be taken at baseline and again after thirty days during the follow-up appointment.
1 secondary outcome
Improvement in Functional Capacity
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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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.
Ernst Schwarz, MD, PhD principal investigator
California Medical Institute, Cedars Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide supplement in people with Prehypertension, run by Neogenis Laboratories 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 10 Sep 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Results are not available in the source record.
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?
Reduction in Systolic and Diastolic Blood Pressure Readings (time frame: 30 days). 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 10 Sep 2013.