A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolle… (NCT07030101) | Clinical Trial Compass
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 on treatment of hypertension.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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 ≤ 179 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.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a drug called TCA108 for uncontrolled high blood pressure — can you tell me anything about what this medication is and how it works differently from the blood pressure medications I'm already on or could try?
2The trial is Phase 3, which means it's a later-stage study — does that mean there's already some safety and effectiveness data from earlier studies that you could review with me before I consider this?
3The study measures changes in systolic blood pressure after 12 weeks — based on where my blood pressure is right now, do you think 12 weeks on a new treatment in a trial makes sense, or should we try adjusting my current medications first?
4Since this trial isn't recruiting yet, how long might it be before it actually opens, and is waiting for it a realistic option given how uncontrolled my blood pressure currently is?
5If I were to eventually enroll in this kind of trial, what would participation actually look like in terms of visits, monitoring, and any restrictions on other medications I might need to take?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean change from baseline systolic blood pressure (SBP) after 12 weeks of treatment
. 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.