What side effects are associated with this type of intervention?

Common treatments for hypertension that involve vasodilation through nitric oxide production, such as nitrate-based therapies, can cause side effects including headaches, dizziness, hypotension, and gastrointestinal disturbances like nausea and vomiting. Chronic use may lead to tolerance, reducing their effectiveness. Other vasodilators, such as PDE-5 inhibitors, can also cause headaches, flushing, and hypotension, and should not be combined with nitrates due to the risk of severe hypotension.

What prior FDA approvals exist?

FDA-approved treatments for hypertension that utilize nitric oxide pathways or have similar vasodilatory effects include nitrates like nitroglycerin and isosorbide mononitrate. These drugs work by releasing nitric oxide, which relaxes blood vessels and lowers blood pressure. Additionally, phosphodiesterase-5 inhibitors (PDE-5 inhibitors) such as sildenafil, although primarily used for erectile dysfunction, have been studied for their vasodilatory effects in pulmonary hypertension. These treatments share a common mechanism with Neo40(TM) by promoting vasodilation through the nitric oxide pathway.

What other types of research exist?

Promising alternatives to Neo40(TM) for hypertension treatment include: 1) Beetroot juice, which is rich in inorganic nitrates and has shown efficacy in increasing nitric oxide levels and improving vascular function. 2) Soluble guanylate cyclase stimulators like vericiguat, which have shown potential benefits in heart failure patients and may improve vascular health. 3) Tetrahydrobiopterin (BH4) supplementation, which has been shown to restore endothelial function and improve nitric oxide bioactivity in smokers, suggesting potential benefits for hypertensive patients.

← Back to Search

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

Must not have

Existence of any significant internal or cardiovascular disease

Current use of any antihypertensive medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Summary

This trial is testing a lozenge called Neo40(TM) that contains nitrates. It aims to help healthy adults who have slightly high blood pressure. The lozenge works by widening blood vessels, which can lower blood pressure. Neo40(TM) lozenge contains nitrates, which have been shown to reduce blood pressure by converting to nitric oxide, a vasodilator.

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.

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).

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a serious heart or internal disease.

Select...

I am currently taking medication for high blood pressure.

Select...

I am able to give informed consent and follow up on my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Reduction in Systolic and Diastolic Blood Pressure Readings

Secondary study objectives

Improvement in Functional Capacity

Other study objectives

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

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for hypertension often focus on vasodilation to reduce blood pressure. Nitrate-based treatments, like Neo40(TM), work by increasing nitric oxide (NO) production, which relaxes blood vessels and improves blood flow. This mechanism is crucial for hypertension patients as it directly reduces vascular resistance and lowers blood pressure. Other common treatments include ACE inhibitors and ARBs, which block the effects of angiotensin II, a molecule that constricts blood vessels, and calcium channel blockers, which relax blood vessel muscles. These treatments are essential for managing hypertension and preventing complications such as stroke and heart disease.

Antihypertensive treatment and endothelium-dependent venodilation in sleep-disordered breathing.Nitric oxide and atherosclerotic lesion progression: an overview.[The activation of soluble guanylate cyclase by new NO donors as the basis of a directed search for new efficacious vasodilators and antiaggregants].