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Dietary Supplement
Nitric Oxide Supplement for Prehypertension
Phase 1 & 2
Waitlist Available
Led By Ernst Schwarz, MD, PhD
Research Sponsored by Neogenis Laboratories
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Study Summary
This trial found that taking Neo40, a nitrate supplement in the form of a lozenge, will reduce blood pressure in adults who have prehypertension.
Who is the study for?
This trial is for adults aged 18-80 with prehypertension, which means their blood pressure readings are at or above 135/80 mmHg. Participants must be able to give informed consent and follow the study's procedures. Those with serious internal or heart diseases, using blood pressure meds, or unable to consent are excluded.Check my eligibility
What is being tested?
The study tests if Neo40(TM), a nitric oxide supplement taken orally as a lozenge, can lower blood pressure in prehypertensive adults compared to a placebo (a dummy pill).See study design
What are the potential side effects?
Potential side effects of the nitric oxide supplement may include headaches, dizziness due to low blood pressure, possible stomach upset or changes in heart rate. Placebo effects should have no active side effects but can cause similar symptoms due to psychological factors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction in Systolic and Diastolic Blood Pressure Readings
Secondary outcome measures
Improvement in Functional Capacity
Other outcome measures
Improvement in Quality of Life
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Nitric Oxide supplementActive Control1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Neogenis LaboratoriesLead Sponsor
5 Previous Clinical Trials
164 Total Patients Enrolled
2 Trials studying Hypertension
109 Patients Enrolled for Hypertension
Ernst Schwarz, MD, PhDPrincipal InvestigatorCalifornia Medical Institute, Cedars Sinai Medical Center
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your blood pressure is consistently at or above 135/80 mmHg when you are resting.I have a serious heart or internal disease.I am currently taking medication for high blood pressure.I am able to give informed consent and follow up on my treatment.I am between 18 and 80 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Nitric Oxide supplement
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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