Essential Arterial HypertensionPhase 3ATHESANCT06608472
Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
A Phase 3 study testing N0877 and Benicar HCT ® Tablets 40 mg/25 mg in people with Essential Arterial Hypertension, run by Eurofarma Laboratorios S.A..
Trial summary
This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Arterial Hypertension
- What is being tested?
- N0877 and Benicar HCT ® Tablets 40 mg/25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2027to 30 Oct 2029
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Ability to confirm voluntary participation and agree to all purposes of the study, signing and dating the Informed Consent Form in two copies.
- Age ≥ 18 years.
- Medical office blood pressure with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg without pharmacological treatment or which is not adequately controlled with monotherapy or with a combination of two drugs in which at least one of the drugs is not at the maximum dose.
- Uncontrolled arterial hypertension (medical office BP with SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg) after at least two (02) weeks of run-in treatment.
- Compliance with run-in treatment ≥ 80% and ≤ 120%.
Who cannot join
- Pregnant or lactating women.
- Women in the reproductive age or of childbearing potential who do not agree to use a proven effective contraceptive method, unless they are surgically sterile or expressly declare themselves to be free from the risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.
- Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg.
- Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing\'s syndrome).
- Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and/or Chronic Kidney Disease stage IV or V.
- History of hypertensive emergencies in the last 6 months.
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- Moderate to severe cardiovascular (acute myocardial infarction or unstable angina, unstable or life-threatening arrhythmia) and/or cerebrovascular events within the last 6 months or any other disorder that in the opinion of the investigator excludes the participant from the study.
- Participant who is unwilling to switch from hypertension treatment to study medications.
- 12-lead electrocardiogram (ECG) with any clinically significant abnormality.
- Drug or alcohol abuse in the last 2 years.
- Allergic or hypersensitivity reactions to angiotensin II receptor blockers, thiazide diuretics or medication excipients.
About this study
Official title: A Phase III, Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, Efficacy and Safety Study of a New Fixed-dose Combination of an Angiotensin Receptor Blocker and a Thiazide Diuretic for the Treatment of Essential (Primary) Arterial Hypertension
This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.
Read the detailed description
This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy (olmesartan 40 mg + hydrochlorothiazide 25 mg) in individuals with stage 2 primary arterial hypertension (SBP ≥ 160 ≤ 179 mm Hg or DBP ≥ 100 ≤ 109 mm Hg). This study will be used to support the registration of the new FDC of Eurofarma Laboratórios S.A.
The randomized treatment period aims to demonstrate the non-inferiority of the new combination compared to its comparator on the SBP in patients with SAH in 8 weeks of treatment after randomization.
Throughout the study, the participant must attend to four (04) in-person visits to the research site, being one Screening Visit (VS/V1) throughout the run-in period, one Randomization Visit (VR/V2), one follow-up visit after four (04) weeks (V3), and one Final Visit (VF/V4) after eight (08) weeks of randomized treatment, this being the visit to assess the primary endpoint of the study
- Conditions
- Essential Arterial Hypertension
- Being tested
- N0877, Benicar HCT ® Tablets 40 mg/25 mg
- Keywords
- hypertension, blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N0877Drug
1 tablet of N0877 and 1 tablet of Placebo of Benicar HCT®
Benicar HCT ® Tablets 40 mg/25 mgDrug
1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877
| Study group | Role | What they receive |
|---|---|---|
| N0877 | Experimental | in the test group will be required to take 1 tablet of the test drug N0877. 1 tablet a day for 56 days +/- 4 days. Receives: Drug: N0877 |
| Benicar HCT® | Active comparator | in the test group will be required to take 1 tablet of the Benicar HCT®. 1 tablet a day for 56 days +/- 4 days. Receives: Drug: Benicar HCT ® Tablets 40 mg/25 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline
To demonstrate the non-inferiority of the N0877 to double combination with an already established profile (olmesartan 40 mg + hydrochlorothiazide 25 mg) on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 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 posted23 Sep 2024
- Study start30 Jan 2027 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Why it stopped: Strategic change in development priorities.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential Arterial HypertensionStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06608472
- Sponsor's protocol ID
- EF187
- Acronym
- ATHESA
- Status last verified
- Oct 2026
- First submitted
- 19 Sep 2024
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-blind, Double-dummy, Active-controlled, Multicenter, Efficacy and Safety Study of a New Fixed-dose Combination of an Angiotensin Receptor Blocker and a Thiazide Diuretic for the Treatment of Essential (Primary) Arterial Hypertension
- ClinicalTrials.gov ID
- NCT06608472
- Acronym / sponsor ID
- ATHESA / EF187
- Conditions
- Essential Arterial Hypertension
- Keywords
- hypertension, blood pressure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Strategic change in development priorities.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eurofarma Laboratorios S.A.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2027 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 23 Sep 2024 (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.
This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.
Detailed description
This is a phase III, non-inferiority, randomized, double-blind, double-dummy, active-controlled, multicenter study to compare the efficacy and safety of N0877 versus double combination with already established efficacy (olmesartan 40 mg + hydrochlorothiazide 25 mg) in individuals with stage 2 primary arterial hypertension (SBP ≥ 160 ≤ 179 mm Hg or DBP ≥ 100 ≤ 109 mm Hg). This study will be used to support the registration of the new FDC of Eurofarma Laboratórios S.A.
The randomized treatment period aims to demonstrate the non-inferiority of the new combination compared to its comparator on the SBP in patients with SAH in 8 weeks of treatment after randomization.
Throughout the study, the participant must attend to four (04) in-person visits to the research site, being one Screening Visit (VS/V1) throughout the run-in period, one Randomization Visit (VR/V2), one follow-up visit after four (04) weeks (V3), and one Final Visit (VF/V4) after eight (08) weeks of randomized treatment, this being the visit to assess the primary endpoint of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| N0877 | Experimental | Drug: N0877in the test group will be required to take 1 tablet of the test drug N0877. 1 tablet a day for 56 days +/- 4 days. |
| Benicar HCT® | Active comparator | Drug: Benicar HCT ® Tablets 40 mg/25 mgin the test group will be required to take 1 tablet of the Benicar HCT®. 1 tablet a day for 56 days +/- 4 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to confirm voluntary participation and agree to all purposes of the study, signing and dating the Informed Consent Form in two copies.
- Age ≥ 18 years.
- Medical office blood pressure with SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg without pharmacological treatment or which is not adequately controlled with monotherapy or with a combination of two drugs in which at least one of the drugs is not at the maximum dose.
- Uncontrolled arterial hypertension (medical office BP with SBP ≥ 140 mm Hg or DBP ≥ 90 mm Hg) after at least two (02) weeks of run-in treatment.
- Compliance with run-in treatment ≥ 80% and ≤ 120%.
Key exclusion criteria (11 listed)
- Pregnant or lactating women.
- Women in the reproductive age or of childbearing potential who do not agree to use a proven effective contraceptive method, unless they are surgically sterile or expressly declare themselves to be free from the risk of pregnancy because they do not engage in sexual practices or engage in them in a non-reproductive manner.
- Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg.
- Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing\'s syndrome).
- Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and/or Chronic Kidney Disease stage IV or V.
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 |
|---|---|---|
| N08771 tablet of N0877 and 1 tablet of Placebo of Benicar HCT® | Drug | N0877 |
| Benicar HCT ® Tablets 40 mg/25 mg1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877 | Drug | Benicar HCT® |
Primary outcome
Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline
Time frame: 8 weeks
To demonstrate the non-inferiority of the N0877 to double combination with an already established profile (olmesartan 40 mg + hydrochlorothiazide 25 mg) on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N0877 and Benicar HCT ® Tablets 40 mg/25 mg in people with Essential Arterial Hypertension, run by Eurofarma Laboratorios S.A..
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 5 inclusion and 11 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: withdrawn, as of the sponsor's last update on 26 Oct 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in SBP in the sitting position at medical office at week 8 after randomization from baseline (time frame: 8 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 26 Oct 2026.