NCT06608472WithdrawnPhase 3
Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension
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
Source: ClinicalTrials.gov · Last updated 26 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 19 Sept 2024
- Start date
- 30 Jan 2027
- Primary completion date
- 30 Apr 2028
- Lead sponsor
- Eurofarma Laboratorios S.A.
- Diseases
- High blood pressure
- NCT number
- NCT06608472
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant presence of Coronary Artery Disease, Congestive Heart Failure, Liver Failure and/or Chronic Kidney Disease stage IV or V.
- Drug or alcohol abuse in the last 2 years.
Other illness
- Resistant hypertension or secondary hypertension of any etiology (including renovascular disease, pheochromocytoma and Cushing\'s syndrome).
- 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.
- Allergic or hypersensitivity reactions to angiotensin II receptor blockers, thiazide diuretics or medication excipients.
Age
- 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.
Other
- Pregnant or lactating women.
- Medical office blood pressure with SBP ≥ 180 mm Hg or DBP ≥ 110 mm mmHg.
- 12-lead electrocardiogram (ECG) with any clinically significant abnormality.
Who the study is looking for
- 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%.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.