Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
NCT ID: NCT06608472
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE3
292 participants
INTERVENTIONAL
2026-11-30
2029-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
N0877
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.
N0877
1 tablet of N0877 and 1 tablet of Placebo of Benicar HCT®
Benicar HCT®
in the test group will be required to take 1 tablet of the Benicar HCT®. 1 tablet a day for 56 days +/- 4 days.
Benicar HCT ® Tablets 40 mg/25 mg
1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
N0877
1 tablet of N0877 and 1 tablet of Placebo of Benicar HCT®
Benicar HCT ® Tablets 40 mg/25 mg
1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Age ≥ 18 years.
3. 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.
4. 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.
5. Compliance with run-in treatment ≥ 80% and ≤ 120%.
Exclusion Criteria
2. 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.
3. Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg.
4. Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing\'s syndrome).
5. Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and/or Chronic Kidney Disease stage IV or V.
6. History of hypertensive emergencies in the last 6 months.
7. 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.
8. Participant who is unwilling to switch from hypertension treatment to study medications.
9. 12-lead electrocardiogram (ECG) with any clinically significant abnormality.
10. Drug or alcohol abuse in the last 2 years.
11. Allergic or hypersensitivity reactions to angiotensin II receptor blockers, thiazide diuretics or medication excipients.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eurofarma Laboratorios S.A.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eurofarma Laboratórios S.A
Itapevi, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EF187
Identifier Type: -
Identifier Source: org_study_id