Overview

This trial is active, not recruiting.

Condition prehypertension
Treatments nitric oxide supplement, placebo
Phase phase 1/phase 2
Sponsor Neogenis Laboratories
Start date January 2013
End date September 2013
Trial size 30 participants
Trial identifier NCT01937754, Neo-4085

Summary

Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Active Comparator)
nitric oxide supplement Neo40 Daily
Lozenge consisting of beetroot and 75 mg caffeine
(Placebo Comparator)
placebo
Same form factor and flavor as test lozenge but contains no active ingredients

Primary Outcomes

Measure
Reduction in Systolic and Diastolic Blood Pressure Readings
time frame: 30 days

Secondary Outcomes

Measure
Improvement in Functional Capacity
time frame: 30 days

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Adults between the ages of 18 to 80 years - Two blood pressure readings of >/=135/80 mmHg at rest, thus representing prehypertension - Informed consent Exclusion Criteria: - 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.

Additional Information

Official title Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Principal investigator Ernst Schwarz, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2013.
Information provided to ClinicalTrials.gov by Neogenis Laboratories.