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

NCT05385770 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 890

Last updated 2025-09-11

No results posted yet for this study

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

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-08
Primary Completion
2024-07-11
Completion
2024-07-19

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385770 on ClinicalTrials.gov