Status:
UNKNOWN
To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure
Lead Sponsor:
Valbiotis
Collaborating Sponsors:
BioTeSys GmbH
Conditions:
Elevated Blood Pressure
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The main objective of the study will be to compare the efficacy of a 2.65 g/day dose of TOTUM-854 versus placebo in decreasing SBP in subjects with high-normal blood pressure and Grade I hypertension ...
Eligibility Criteria
Inclusion
- Main
- Office Systolic Blood Pressure between 130 and 159 mmHg and Diastolic Blood Pressure \< 100 mmHg
- Body Mass Index (BMI) between 18.5 and 35 kg/m²
- Weight stable within ± 5 % in the last three months
- No significant change in food habits or in physical activity in the 3 months prior to randomization and agreeing to keep them unchanged throughout the study
- Main
Exclusion
- Known or suspected secondary hypertension
- Known hypertensive retinopathy and/or hypertensive encephalopathy;
- History of spontaneous or drug-induced angioedema;
- Clinically significant valvular heart disease or severe aortic stenosis
- History of acute coronary syndrome (non-ST elevation myocardial infarction, ST elevation myocardial infarction, and unstable angina pectoris), stroke, or transient ischemic attack within 6 months prior to screening
- Suffering from a severe chronic disease or gastrointestinal disorders found to be inconsistent with the conduct of the study by the investigator
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT05370625
Start Date
May 30 2022
End Date
April 1 2024
Last Update
July 18 2023
Active Locations (1)
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1
BioTeSys
Esslingen am Neckar, Germany, 73728