NCT06608472

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 292 (estimated)
• Sponsor: Eurofarma Laboratorios S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	N0877	1 tablet of N0877 and 1 tablet of Placebo of Benicar HCT®
DRUG	Benicar HCT ® Tablets 40 mg/25 mg	1 tablet of Benicar HCT® and 1 tablet of Placebo of N0877

Timeline

• Start date: 2026-11-30
• Primary completion: 2028-04-30
• Completion: 2029-10-30
• First posted: 2024-09-23
• Last updated: 2024-11-27

Locations

1 site across 1 country: Brazil