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

NCT07030101 | Not Yet Recruiting Phase 3

• 1 other identifier: TCA108-III-0124
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

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

  10 weeks

Secondary Outcomes (6)

• Proportion of participants with blood pressure <130/80 mmHg after 10 weeks of treatment

  10 weeks

• Proportion of participants with systolic blood pressure (SBP) <130 mmHg or a change from baseline SBP of at least a 10 mmHg decrease after 10 weeks of treatment

  10 weeks

• Mean change from baseline diastolic blood pressure (DBP) after 10 weeks of treatment

  10 weeks

• Proportion of participants with diastolic blood pressure (DBP) <80 mmHg or a change from baseline DBP of at least a 5 mmHg decrease after 10 weeks of treatment

  10 weeks

• Mean change in 24-hour ABPM (Ambulatory Blood Pressure Monitoring) SBP and DBP from baseline after 10 weeks of treatment

  10 weeks

Study Arms (3)

Bramicar HCT

ACTIVE COMPARATOR

The participants must take 1 tablet per day

Drug: Bramicar HCT

TCA108

EXPERIMENTAL

The participants must take 1 tablet per day

Drug: TCA108

Micardis Anlo

ACTIVE COMPARATOR

The participants must take 1 tablet per day

Drug: Micardis Anlo

Interventions

TCA108 DRUG

TCA108

TCA108

Bramicar HCT DRUG

Bramicar HCT

Bramicar HCT

Micardis Anlo DRUG

Micardis Anlo

Micardis Anlo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• d. Participants on dual antihypertensive therapy at a stable dose for at least four weeks prior to screening, meeting the following criterion:
• Receiving dual therapy with any antihypertensive agents at low or intermediate doses, or a dual combination in which only one of the drugs is at the maximum dose; except for dual therapy involving telmisartan combined with a thiazide diuretic or amlodipine, which will only be allowed when both drugs are at low doses.
• Participants who meet the above criteria at the screening visit must also meet criterion "e" at the randomization 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:
• 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).
• 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

You may not qualify if:

• 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.
• Current ventricular arrhythmia requiring treatment.
• Participants with prolonged corrected QT interval (QTc) \[male \> 450 ms, female \> 470 ms\] or tachyarrhythmia.
• Evidence of a secondary form of hypertension, including but not limited to: aortic coarctation, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease.
• Renal insufficiency with estimated glomerular filtration rate \[eGFR\] \< 30 mL/min (2021 Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] Creatinine Equation), end-stage renal disease requiring dialysis or kidney transplant.
• Serum potassium levels ≥ 5.5 mEq/L or ≤ 3.5 mEq/L.
• Alanine aminotransferase (ALT) \> 2.5 times the upper limit of normal (ULN), aspartate aminotransferase (AST) ≥ 2.5 × ULN, bilirubin \> 2 × ULN.
• Symptomatic hyperuricemia (history of gout or uric acid stones).

Sponsors & Collaborators

• EMS: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Alexandra F.D. Alves, MSc

CONTACT

+551938878917; pesquisa.clinica@ncfarma.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2025
• First Posted: June 19, 2025
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share