NCT01937754UnknownPhase 1
Study of the Effects of an Oral Nitric Oxide Supplement on Functional Capacity and Blood Pressure in Healthy Adults With Prehypertension
Neogenis Laboratories2 sites in 1 country30 target enrollmentStarted: January 1, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Reduction in Systolic and Diastolic Blood Pressure Readings
Study Overview
Brief Summary
Oral supplementation of Neo40(TM), a nitrate lozenge, will reduce blood pressure in healthy adults with clinical prehypertension.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Improvement in Functional Capacity(30 days)
Investigators
Dr. Ernst Schwarz
Attending Cardiologist, Professor of Medicine
Neogenis Laboratories
Study Sites (2)
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