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

Launched by VALBIOTIS · May 6, 2022

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ClinConnect Summary

This clinical trial is studying a new treatment called TOTUM-854 to see if it can help lower blood pressure in people with moderately high blood pressure. Participants will take either a daily dose of 2.65 grams of TOTUM-854 or a placebo (a dummy treatment that looks like the real one but has no active ingredients) for 12 weeks. The main goal is to see if TOTUM-854 can effectively reduce systolic blood pressure, which is the top number in a blood pressure reading.

To be eligible for the trial, participants should be adults aged between 65 and 74 years, with a systolic blood pressure between 130 and 159 mmHg and a diastolic blood pressure less than 100 mmHg. They should have a stable weight and no significant changes in their diet or physical activity in the last three months. However, certain people, such as those with serious heart conditions or recent medical events like a heart attack or stroke, may not qualify for the study. Participants can expect regular check-ins and monitoring throughout the study to ensure their safety and gather information about how well the treatment is working.

Gender

ALL

Eligibility criteria

• Main 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