NCT05385770

Study to Evaluate and Compare the Efficacy and Safety of AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects

A Multicentre, Randomized, Double-blind Study to Evaluate and Compare the Efficacy and Safety of 8-week Treatment With AZM and AML Combined and Alone in Mild-to-moderate Essential Hypertensive Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 890 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an 8-week, randomized, double-blind Phase 3, multicentre study to determine the optimal dose of AZM and AML in combination therapy and to compare efficacy and tolerability of the combined therapy to each of the monotherapy in essential hypertensive subjects who are not adequately controlled on AZM and AML monotherapy.

Conditions

• Essential Hypertension

Interventions

Type	Name	Description
DRUG	AZM X mg + AML Y mg	tablet, single dose, QD, oral administration
DRUG	AZM X mg + AML Y' mg	tablet, single dose, QD, oral administration
DRUG	AZM X' mg + AML Y mg	tablet, single dose, QD, oral administration
DRUG	AZM X' mg + AML Y' mg	tablet, single dose, QD, oral administration
DRUG	AZM X mg	tablet, single dose, QD, oral administration
DRUG	AZM X' mg	tablet, single dose, QD, oral administration
DRUG	AML Y mg	tablet, single dose, QD, oral administration
DRUG	AML Y' mg	tablet, single dose, QD, oral administration

Timeline

• Start date: 2022-07-08
• Primary completion: 2024-07-11
• Completion: 2024-07-19
• First posted: 2022-05-23
• Last updated: 2025-09-11

Locations

1 site across 1 country: South Korea