Status:
NOT_YET_RECRUITING
Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
Lead Sponsor:
Eurofarma Laboratorios S.A.
Conditions:
Essential Arterial Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 es...
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 es...
Eligibility Criteria
Inclusion
- 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%.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
November 30 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2029
Estimated Enrollment :
292 Patients enrolled
Trial Details
Trial ID
NCT06608472
Start Date
November 30 2026
End Date
October 30 2029
Last Update
November 27 2024
Active Locations (1)
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1
Eurofarma Laboratórios S.A
Itapevi, São Paulo, Brazil, 06696-000