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

Launched by EMS · Jun 18, 2025

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ClinConnect Summary

This clinical trial is studying a new medicine called TCA108 to see if it is safe and effective for treating adults with high blood pressure (hypertension) that is not well controlled with their current medications. The goal is to find out if TCA108 can help lower blood pressure in people who have been taking two blood pressure medicines but still have readings that are higher than recommended.

To join the study, participants need to be 18 years or older, have a specific range of high blood pressure confirmed by tests, and already be on two stable blood pressure medicines (but not a certain combination). Women who can become pregnant must use reliable birth control and have negative pregnancy tests before joining. The study has several health-related requirements to ensure safety, so people with certain heart, kidney, or other serious health problems may not be eligible. Participants will be closely monitored for safety and blood pressure changes throughout the study. If you or a loved one have uncontrolled high blood pressure despite current treatment, this trial might be an option to consider, but it’s important to discuss eligibility and details with your healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be 18 years of age or older at the time of signing the informed consent.
• • 2. Participant with essential hypertension.
• • 3. Participant has SBP ≥140 mmHg and ≤170 mmHg and/or DBP ≥90 mmHg and ≤110 mmHg, confirmed by triplicate measurements from the reference arm at screening.
• • 4. Participant is currently on a stable dual antihypertensive therapy (excluding those on telmisartan plus a thiazide diuretic) for at least 4 weeks before screening.
• • 5. Participant has uncontrolled hypertension confirmed by ABPM during the screening period.
• • 6. Participant is male or female at birth.
• 7. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
• * Not a childbearing potential (CBP) participant as defined below:
• • surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy as confirmed by review of the participant's medical records, medical examination, or medical history interview), or postmenopausal (defined as no menses for 12 months).
• 8. 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:
• • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal)
• • progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable)
• • intrauterine device
• • intrauterine hormone-releasing system
• • bilateral tubal occlusion (if not recently performed, should be established, or confirmed if any doubt)
• • vasectomized partner (if not recently performed, should be established, or confirmed if any doubt)
• • complete sexual abstinence (only if this is within the patients preferred lifestyle).
• • 9. 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:
• • 1. Known contraindication or a history of hypersensitivity to any of the study intervention components telmisartan, chlorthalidone, amlodipine besylate and hydrochlorothiazide.
• • 2. Essential hypertension based on a DBP \>110mmHg and SBP \>170 mmHg.
• • 3. Previous acute coronary syndrome, unstable angina, myocardial infarction, or stroke within 6 months before screening.
• • 4. Body mass index \>45 kg/m2.
• • 5. Uncontrolled type 1 or 2 diabetes mellitus (glycated hemoglobin \>8.5%).
• • 6. Heart failure New York Heart Association Class IV.
• • 7. Coronary artery disease with planned percutaneous coronary intervention within the next 6 months.
• • 8. End-stage renal disease requiring dialysis or kidney transplant.
• • 9. Current ventricular arrhythmia requiring treatment.
• • 10. Patients with a prolonged corrected QT (QTc) interval \[male \>450 msec, female \>470 msec\] or tachyarrhythmia.
• • 11. Evidence of a secondary form of hypertension, including but not limited to any of the following: coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing disease, pheochromocytoma, polycystic kidney disease.
• • 12. Any chronic inflammatory condition needing chronic anti-inflammatory therapy.
• • 13. History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there was evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• • 14. Chronic disease of any nature that contraindicates the participant's participation according to the Investigator's judgment, in particular renal failure with an estimated glomerular filtration rate \<30 mL/min (Chronic Kidney Disease Epidemiology Collaboration \[CKD EPI\] Creatinine Equation 2021), serum potassium levels ≥5.5 mEq/L or ≤3.5 mEq/L, alanine aminotransferase \>2.5 times the upper limit of normal (ULN), aspartate aminotransferase ≥2.5 × ULN, bilirubin \>2 × ULN, and blood dyscrasias.
• 15. Currently taking any of the following concomitant medication(s) with the potential to interfere with the evaluation of efficacy, safety, and tolerability:
• • Oral corticosteroids within 3 months of screening. Long-term treatment with systemic corticosteroids is also prohibited during study participation. Short-term treatment (\<5 days) is acceptable during the treatment period.
• • Chronic stable or unstable use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid is prohibited. Chronic use is defined as one week of treatment. In addition, the intermittent use of NSAIDs is discouraged throughout the duration of this study. If intermittent treatment is required, NSAIDs must not be used for more than a total of one week. For all participants requiring analgesic or antipyretic agents, the use of paracetamol is recommended during study participation.
• • The use of short-acting oral nitrates (e.g., sublingual nitroglycerin) is permitted; however, participants should not take short-acting oral nitrates within 4 hours of screening or any subsequent study visit.
• • The use of long-acting oral nitrates (e.g., Isordil) is permitted; however, the dose must be stable for at least 2 weeks prior to screening and randomization.
• • The use of sympathomimetic decongestants is permitted; however, not within 1 day prior to any clinic visit/BP assessment.
• • The use of theophylline is permitted; however, the dose must be stable for at least 4 weeks prior to screening and throughout study participation.
• • The use of phosphodiesterase type V inhibitors is permitted; however, participants must refrain from taking these medications within 1 day of screening or any subsequent study visit.
• • The use of α-blockers is not permitted, with the exception of alfuzosin and tamsulosin for prostatic symptoms.
• • 16. Participation in a concurrent interventional medical investigation or pharmacologic clinical trial. Patients in observational, natural history or epidemiological studies not involving an intervention are eligible.
• • 17. Concomitant illness, physical impairment or mental condition which in the opinion of the study team / primary care physician could interfere with the conduct of the study including outcome assessments.
• • 18. Participant's responsible primary care or other responsible physician believes it is not appropriate for participant to switch current therapy.
• • 19. Female participants who are pregnant, breastfeeding or who want to become pregnant.
• • 20. History of drug or alcohol abuse within the last 2 years.
• • 21. Unwillingness or inability to give informed consent.