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

NCT ID: NCT05385770

Last Updated: 2025-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 890 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-08
• Study Completion Date: 2024-07-19

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AZM Xmg

1\. AZM Xmg (4 weeks) Non-responder -\> AZM Xmg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AZM X mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM X'mg

1\. AZM X'mg (4 weeks) Non-responder -\> AZM X'mg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AZM X' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AML Ymg

1\. AML Ymg (4 weeks) Non-responder -\> AML Ymg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AML Y mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AML Y'mg

1\. AML Y'mg (4 weeks) Non-responder -\> AML Y'mg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AML Y' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM/AML X/Ymg

1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)

2. AML Ymg (4 weeks) Non-responder -> AZM Xmg + AML Ymg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AZM X mg + AML Y mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM X mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AML Y mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM/AML X'/Ymg

1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)

2. AML Ymg (4 weeks) Non-responder -> AZM X'mg + AML Ymg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AZM X' mg + AML Y mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM X' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AML Y mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM/AML X/Y'mg

1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)

2. AML Y'mg (4 weeks) Non-responder -> AZM Xmg + AML Y'mg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AZM X mg + AML Y' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM X mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AML Y' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM/AML X'/Y'mg

1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)

2. AML Y'mg (4 weeks) Non-responder -> AZM X'mg + AML Y'mg (8 weeks)

Group Type: ACTIVE_COMPARATOR

AZM X' mg + AML Y' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AZM X' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

AML Y' mg

Intervention Type: DRUG

tablet, single dose, QD, oral administration

Interventions

AZM X mg + AML Y mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AZM X mg + AML Y' mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AZM X' mg + AML Y mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AZM X' mg + AML Y' mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AZM X mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AZM X' mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AML Y mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

AML Y' mg

tablet, single dose, QD, oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subjects voluntarily agree to participate in the trial and signed the written ICF, after listening to the purpose, method, and effect of clinical trial
• Male or female adult subjects (Legal minimum age of adult requirement is country specific, and requirement of current country specific regulations will be applied) below the age of 75 years, inclusive
• Subjects with mild-to-moderate essential hypertension
• Subjects who are capable of understanding and complying with protocol requirements

Exclusion Criteria

• Subjects who have msitSBP >180 mmHg or msitDBP >110 mmHg; Subjects who have difference in the blood pressure between 3 measurements (confirmed by a second set of three measurements; 3 sitting systolic BP (sitSBP) measurements differing by more than 20 mmHg or 3 sitting diastolic BP (sitDBP) measurements differing by more than 10 mmHg)
• Secondary hypertension, Symptomatic orthostatic hypotension
• Clinically significant Electrocardiogram (ECG) abnormalities, Severe heart disease, Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically significant arrhythmia, Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve
• Severe cerebrovascular disease, Known moderate or malignant retinopathy within the past 6 months; History of unexplained syncope within the prior 2 years, or a known syncopal disorder
• Significant thyroid disease, Type 1 or 2 diabetes mellitus with poor glucose control, Wasting disease, Autoimmune diseases, Connective tissue disease
• Subjects who have clinically significant laboratory abnormalities : creatinine clearance < 30 mL/min, serum creatinine > 2 mg/dL or > 200 μmol/L, serum potassium <3.5 mmol/L or > 5.5mmol/L, alanine aminotransferase or aspartate aminotransferase > 3 × upper limit normal (ULN)
• Any surgical or medical condition of the gastrointestinal tract that might significantly alter the absorption, distribution, metabolism, or excretion of the drug
• Positive for HIV, HCV Ab, and/or HBsAg
• History of drug or alcohol abuse within the past 1 year
• Subjects who are pregnant or lactating women, women suspected of being pregnant, women who wish to be pregnant during the study, or women of child-bearing potential who are not using medically acceptable methods of contraception
• Any chronic inflammatory condition needing chronic anti-inflammatory therapy, A known hypersensitivity to any main excipients and components of the investigational drugs or other drugs in the same class, Subjects who have previously experienced symptoms characteristic of angioedema during treatment with angiotensin-converting enzyme inhibitors or angiotensin II subtype 1 receptor blocker
• Subjects who have received any investigational product within 28 days prior to screening or is currently participating in another investigational study
• Subjects who are required to take excluded medications at any point during the study

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celltrion

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Celltrion

Incheon, , South Korea

Countries

South Korea

Other Identifiers

CT-L05-301

Identifier Type: -

Identifier Source: org_study_id