HypertensionPhase 3TRÍADE-HANCT07030101
A Study to Investigate Efficacy and Safety of a TCA108 in Participants ≥18 Years With Uncontrolled Hypertension
A Phase 3 study testing TCA108, Bramicar HCT and Micardis Anlo in people with Hypertension, run by EMS.
Trial summary
The purpose of this study if to evaluate the efficacy and safety of TCA108 on treatment of hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- TCA108, Bramicar HCT and Micardis Anlo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
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- 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
- 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).
- 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.
Who cannot join
- 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 > 179 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%).
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- 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).
- Blood dyscrasias.
- Any chronic inflammatory condition requiring chronic anti-inflammatory therapy.
- Disease, physical impairment, or mental condition that, in the judgment of the principal investigator, may interfere with study conduct, including outcome assessments.
- History of malignancy in any organ system, treated or untreated, within the past 5 years, regardless of evidence of local recurrence or metastasis, except for localized basal cell carcinoma of the skin.
- Any chronic disease that contraindicates participation according to the investigator's judgment.
- Current treatment with any of the following concomitant medications that may interfere with the evaluation of efficacy, safety, and tolerability:
- Prolonged treatment (>15 days) with systemic corticosteroids within the 3 months prior to screening. Prolonged systemic corticosteroid use is also prohibited during study participation. Short-term treatment (<5 days) is acceptable during the study.
- Chronic stable or unstable use of nonsteroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid, with chronic use defined as ≥1 week of treatment. Intermittent NSAID use is discouraged throughout the study; if necessary, NSAIDs should not be used for more than one week in total. For participants requiring analgesic or antipyretic agents, acetaminophen is recommended during the study.
- Use of short-acting oral nitrates (e.g., sublingual nitroglycerin) is permitted; however, participants must not take short-acting oral nitrates within 4 hours prior to any study visit/BP assessment and within 4 hours prior to and during ABPM.
- 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 maintained throughout the study.
- Use of sympathomimetic decongestants is permitted; however, not within 1 day prior to any study visit/BP assessment and within 1 day prior to and during ABPM.
- Use of theophylline is permitted; however, the dose must be stable for at least 4 weeks prior to screening and maintained throughout the study.
- Use of phosphodiesterase type V inhibitors is permitted; however, participants must abstain from taking these medications within 1 day prior to screening or any subsequent study visit, as well as 1 day prior to and during ABPM.
- Use of α-blockers is not permitted, except for alfuzosin and tamsulosin for prostatic symptoms, provided the dose is stable for at least 4 weeks prior to screening and maintained throughout the study.
- Use of drugs acting on the central nervous system (such as antidepressants, antipsychotics, and antiepileptics) is permitted, provided the dose is stable for at least 3 months prior to screening and maintained throughout the study.
- Research participants who have participated in clinical trial protocols within the past 12 (twelve) months (Resolution CNS 251, August 7, 1997, item III, subitem J), unless the investigator determines that there may be direct benefit to the participant.
- Participants who do not have an indication for modification of current therapy, in the judgment of the principal investigator or another physician responsible for the participant.
- Participants who are pregnant, breastfeeding, or planning to become pregnant, or female participants of childbearing potential not using a reliable contraceptive method as described in section 13.2.
- History of drug or alcohol abuse within the past 2 years.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3 Double-blind, Multicenter, Randomized, Double-blind, Triple-dummy, Controlled Trial to Assess the Efficacy and Safety of a TCA108 in Participants ≥18 Years of Age With Uncontrolled Hypertension
The purpose of this study if to evaluate the efficacy and safety of TCA108 on treatment of hypertension.
- Conditions
- Hypertension
- Being tested
- TCA108, Bramicar HCT, Micardis Anlo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCA108Drug
TCA108
Bramicar HCTDrug
Bramicar HCT
Micardis AnloDrug
Micardis Anlo
| Study group | Role | What they receive |
|---|---|---|
| Bramicar HCT | Active comparator | The participants must take 1 tablet per day Receives: Drug: Bramicar HCT |
| TCA108 | Experimental | The participants must take 1 tablet per day Receives: Drug: TCA108 |
| Micardis Anlo | Active comparator | The participants must take 1 tablet per day Receives: Drug: Micardis Anlo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline systolic blood pressure (SBP) after 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (7)
Proportion of participants with blood pressure <130/80 mmHg after 4, 8 and 12 weeks of treatment
Measured: 12weeks
Proportion of participants with systolic blood pressure (SBP) <130 mmHg or a change from baseline SBP of at least a 10 mmHg decrease after 4, 8 and 12 weeks of treatment
Measured: 12 weeks
Mean change from baseline diastolic blood pressure (DBP) after 4, 8 and 12 weeks of treatment
Measured: 12 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 4, 8 and 12 weeks of treatment
Measured: 12 weeks
Mean change in 24-hour ABPM (Ambulatory Blood Pressure Monitoring) SBP and DBP from baseline after 12 weeks of treatment
Measured: 12 weeks
Evaluate the safety of TCA108 in the treatment of hypertension
The safety will be evaluated considering the incidence of adverse events (AEs) reported during the study period.
Measured: 12 weeks
Mean change from baseline systolic blood pressure (SBP) after 4 and 8 weeks of treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study startNov 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by EMSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EMS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030101
- Sponsor's protocol ID
- TCA108-III-0124
- Acronym
- TRÍADE-HA
- Status last verified
- Jul 2026
- First submitted
- 12 Jun 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Double-blind, Multicenter, Randomized, Double-blind, Triple-dummy, Controlled Trial to Assess the Efficacy and Safety of a TCA108 in Participants ≥18 Years of Age With Uncontrolled Hypertension
- ClinicalTrials.gov ID
- NCT07030101
- Acronym / sponsor ID
- TRÍADE-HA / TCA108-III-0124
- Conditions
- Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- EMSIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 19 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study if to evaluate the efficacy and safety of TCA108 on treatment of hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bramicar HCT | Active comparator | Drug: Bramicar HCTThe participants must take 1 tablet per day |
| TCA108 | Experimental | Drug: TCA108The participants must take 1 tablet per day |
| Micardis Anlo | Active comparator | Drug: Micardis AnloThe participants must take 1 tablet per day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- 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 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.
Key exclusion criteria (34 listed)
- 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 > 179 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCA108TCA108 | Drug | TCA108 |
| Bramicar HCTBramicar HCT | Drug | Bramicar HCT |
| Micardis AnloMicardis Anlo | Drug | Micardis Anlo |
Primary outcome
Mean change from baseline systolic blood pressure (SBP) after 12 weeks of treatment
Time frame: 12 weeks
7 secondary outcomes
Proportion of participants with blood pressure <130/80 mmHg after 4, 8 and 12 weeks of treatment
Time frame: 12weeks
Proportion of participants with systolic blood pressure (SBP) <130 mmHg or a change from baseline SBP of at least a 10 mmHg decrease after 4, 8 and 12 weeks of treatment
Time frame: 12 weeks
Mean change from baseline diastolic blood pressure (DBP) after 4, 8 and 12 weeks of treatment
Time frame: 12 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 4, 8 and 12 weeks of treatment
Time frame: 12 weeks
Mean change in 24-hour ABPM (Ambulatory Blood Pressure Monitoring) SBP and DBP from baseline after 12 weeks of treatment
Time frame: 12 weeks
Evaluate the safety of TCA108 in the treatment of hypertension
Time frame: 12 weeks
Mean change from baseline systolic blood pressure (SBP) after 4 and 8 weeks of treatment
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TCA108, Bramicar HCT and Micardis Anlo in people with Hypertension, run by EMS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra F.D. Alves, MSc (+551938878917, pesquisa.clinica@ncfarma.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline systolic blood pressure (SBP) after 12 weeks of treatment (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.