Last updated: July 31, 2023
Sponsor: Calroy Health Sciences
Overall Status: Completed
Phase
N/A
Condition
Stress
Williams Syndrome
Vascular Diseases
Treatment
Vascanox® HP
Clinical Study ID
NCT05928676
022-CalroyHS
Ages 25-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Mild hypertension defined as brachial artery blood pressure greater than or equal to 130 mm Hg systolic and less than or equal to 140 mm Hg systolic or greater than orequal to 85 mm Hg diastolic or less than 90 mm Hg diastolic while taking or not takingantihypertensive drugs.
- Not currently taking nitric oxide supplements, and not consuming nitric oxidesupplements for 14 days prior to screening.
- Ability to give written informed consent.
- Ability to adhere to study protocol directives and procedures.
Exclusion
Exclusion Criteria:
- Initiated or had a dose change of an antihypertensive agent less than 6 months priorto the enrollment date.
- A positive nitric oxide saliva test strip (result >2) on the day of Screening.
- A positive nitric oxide saliva test strip (result >2) on the day of Baseline/Visit 1.
- A high saliva NO3 test strip result (result >2) but a low NO test strip result.
- Current use of antibiotics.
- Chronic steroid use >15 mg daily.
- Previous myocardial infarction less than 2 years of enrollment date.
- Unstable angina.
- Previous stroke or transient ischemic attack (TIA) less than 2 years of enrollmentdate.
- Uncompensated congestive heart failure (CHF).
- Previous percutaneous transluminal coronary angioplasty (PTCA) or stent less than 2years of enrollment date.
- Previous coronary arterial bypass graft (CABG) less than 2 years of enrollment date.
- Known or previous cancer less than 5 years of enrollment date.
- Type 1 diabetes mellitus.
- Prescribed dosing with insulin, injectable or inhaled.
- Pregnant females.
- Females of child bearing age not on an accepted contraception control method.
- Allergy/sensitivity to study products or their ingredients.
- Current drug or alcohol use or dependence that, in the opinion of the principalinvestigator, would interfere with adherence to study requirements.
- Inability or unwillingness of individual to give written informed consent.
- Current or past participation within 30 calendar days in another clinical trial, aswarranted by the administration of this intervention.
Study Design
Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Vascanox® HP
Phase:
Study Start date:
June 24, 2023
Estimated Completion Date:
July 31, 2023
Connect with a study center
The Hypertension Institute
Nashville, Tennessee 37205
United StatesSite Not Available

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