Fixed-dose Combination of an Angiotensin Receptor Blocker and Thiazide Diuretic for Essential Hypertension

NCT06608472 | Not Yet Recruiting Phase 3

• 1 other identifier: EF187
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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 established efficacy on systolic blood pressure (SBP) in the sitting position in the medical office in patients with SAH after 8 weeks of treatment.

Conditions

Essential Arterial Hypertension

Keywords

hypertension; blood pressure

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Study Arms (2)

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.

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.

Drug: Benicar HCT ® Tablets 40 mg/25 mg

Interventions

N0877 DRUG

1 tablet of N0877 and 1 tablet of Placebo of Benicar HCT®

N0877

Benicar HCT ® Tablets 40 mg/25 mg DRUG

1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877

Benicar HCT®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (1)

Eurofarma Laboratórios S.A

Itapevi, São Paulo, 06696-000, Brazil

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Gleyce Lima

CONTACT

+55 11 50908411; gleyce.lima@eurofarma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 23, 2024
• Study Start (Estimated): November 30, 2026
• Primary Completion (Estimated): April 30, 2028
• Study Completion (Estimated): October 30, 2029
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

BR (1)