Not Yet RecruitingPhase 3

A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension

400 participantsStarted 2026-11

Plain-language summary

The purpose of this study if to evaluate the efficacy and safety of TCA108 in the treatment of hypertension.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Participant must be 18 years of age or older at the time of signing the informed consent.
✓. Participants with a diagnosis of arterial hypertension presenting with SBP ≥ 140 mmHg and ≤ 170 mmHg and DBP ≥ 90 mmHg and ≤ 110 mmHg, confirmed by triplicate measurements from the reference arm at the screening visit.
✓. Participants with uncontrolled hypertension, confirmed by ambulatory blood pressure monitoring (ABPM) performed during the screening period, defined as SBP ≥ 130 mmHg and DBP ≥ 80 mmHg.
✓. Participant is male or female at birth.
✓. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
✓. If the participant is a female of childbearing potential, they must have a negative urine pregnancy test at the screening visit and the randomization visit and they must be willing to use any of the following highly effective acceptable forms of contraception for the course of the study:
✓. Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

✕. Any clinical observation (clinical/physical assessment) or laboratory condition interpreted by the investigator as posing a risk to the participant's involvement in the clinical trial, or the presence of uncontrolled chronic disease(s).
✕. Known contraindication or history of hypersensitivity or intolerance to any components of the medications used during the clinical trial.
✕. Essential hypertension with DBP \> 110 mmHg and/or SBP \> 170 mmHg.
✕. Participants who have experienced any cardiovascular event (acute myocardial infarction, unstable angina, newly diagnosed stable angina, stroke, unstable congestive heart failure requiring treatment adjustment), undergone revascularization procedure, or vascular surgery within the 6 (six) months prior to screening.
✕. Body mass index (BMI) \> 45 kg/m².
✕. Uncontrolled type 1 or type 2 diabetes mellitus (glycated hemoglobin \[HbA1c\] \> 8.5%).
✕. Known heart failure, New York Heart Association (NYHA) Classes III and IV.
✕. Coronary artery disease with planned percutaneous intervention within the next 6 months.

Mean change from baseline systolic blood pressure (SBP) after 10 weeks of treatment

Timeframe: 10 weeks

NCT IDNCT07030101

SponsorEMS

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-05

Alexandra F.D. Alves, MSc

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Participant must be 18 years of age or older at the time of signing the informed consent.
✓. Participants with a diagnosis of arterial hypertension presenting with SBP ≥ 140 mmHg and ≤ 170 mmHg and DBP ≥ 90 mmHg and ≤ 110 mmHg, confirmed by triplicate measurements from the reference arm at the screening visit.
✓. Participants with uncontrolled hypertension, confirmed by ambulatory blood pressure monitoring (ABPM) performed during the screening period, defined as SBP ≥ 130 mmHg and DBP ≥ 80 mmHg.
✓. Participant is male or female at birth.
✓. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
✓. If the participant is a female of childbearing potential, they must have a negative urine pregnancy test at the screening visit and the randomization visit and they must be willing to use any of the following highly effective acceptable forms of contraception for the course of the study:
✓. Participant is capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

✕. Any clinical observation (clinical/physical assessment) or laboratory condition interpreted by the investigator as posing a risk to the participant's involvement in the clinical trial, or the presence of uncontrolled chronic disease(s).
✕. Known contraindication or history of hypersensitivity or intolerance to any components of the medications used during the clinical trial.
✕. Essential hypertension with DBP \> 110 mmHg and/or SBP \> 170 mmHg.
✕. Participants who have experienced any cardiovascular event (acute myocardial infarction, unstable angina, newly diagnosed stable angina, stroke, unstable congestive heart failure requiring treatment adjustment), undergone revascularization procedure, or vascular surgery within the 6 (six) months prior to screening.
✕. Body mass index (BMI) \> 45 kg/m².
✕. Uncontrolled type 1 or type 2 diabetes mellitus (glycated hemoglobin \[HbA1c\] \> 8.5%).
✕. Known heart failure, New York Heart Association (NYHA) Classes III and IV.
✕. Coronary artery disease with planned percutaneous intervention within the next 6 months.