To Assess TOTUM-854 on Blood Pressure in Subjects With Moderately Elevated Blood Pressure

Not Applicable

Recruiting

• Conditions: Elevated Blood Pressure

• Registration Number: NCT05370625
• Lead Sponsor: Valbiotis

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 following 12 weeks of daily intake.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Study Start: 2022-05-30
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-17
• Last Update Posted: 2023-07-18
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure at V4	V4 (12 weeks of intervention)	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo

Secondary Outcome Measures

Name	Time	Method
Evolution of the fasting blood concentration of triglycerides	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Triglycerides (in g/L), TOTUM-854 vs placebo
Evolution of Systolic Blood Pressure	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of total cholesterol	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Total cholesterol (in g/L), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of LDL cholesterol	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	LDL cholesterol (in g/L, Friedewald method), TOTUM-854 vs placebo
Evolution of fasting blood concentration of hsCRP	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	hsCRP (in mg/L), TOTUM-854 vs placebo
Evolution of hip circumference	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Hip circumference (in cm), TOTUM-854 vs placebo
Evolution of cardiovascular disease risk	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Systematic Coronary Risk Estimation value from heartscore calculator, TOTUM-854 vs placebo
Evolution of Diastolic Blood Pressure	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Automated Office Blood Pressure (in mmHg), TOTUM-854 vs placebo
Evolution of fasting blood glycemia	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Glycemia (in mg/dL), TOTUM-854 vs placebo
Evolution of the fasting blood concentration of non-HDL cholesterol	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	non-HDL cholesterol (in g/L), TOTUM-854 vs placebo
Evolution of waist circumference	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Waist circumference (in cm), TOTUM-854 vs placebo
Evolution of waist hip Ratio	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Waist Hip Ratio, TOTUM-854 vs placebo
Evolution of the fasting blood concentration of HDL cholesterol	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	HDL cholesterol (in g/L), TOTUM-854 vs placebo
Evolution of body weight	V0 (inclusion), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Body weight (in kg), TOTUM-854 vs placebo
Delay of occurence of pharmacological treatment requirement for hypertension from V1	V1 (randomisation), V2 (4 weeks of intervention), V3 (8 weeks), V4 (12 weeks)	Dealy between V1 and the date at which the investigator will decide to withdraw the subject from the study because he needs a pharmacological treatment to treat his hypertension, TOTUM-854 vs placebo

Trial Locations

Locations (1)

BioTeSys; 🇩🇪 Esslingen, Germany