NCT05385770

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
890

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 8, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 19, 2024

Completed
Last Updated

September 11, 2025

Status Verified

August 1, 2025

Enrollment Period

2 years

First QC Date

May 18, 2022

Last Update Submit

September 5, 2025

Conditions

Essential Hypertension

Outcome Measures

Primary Outcomes (1)

  • msitSBP

    msitSBP change from baseline

    after 8 weeks of treatment

Secondary Outcomes (5)

  • msitDBP

    after 8 weeks of treatment

  • msitSBP

    after 4 weeks of treatment

  • msitDBP

    after 4 weeks of treatment

  • Proportion of subjects achieving msitSBP < 140 mmHg and/or ΔmsitSBP ≥ 20 mmHg

    after 4, 8 weeks of treatment

  • Proportion of subjects achieving msitDBP < 90 mmHg and/or ΔmsitDBP ≥ 10 mmHg

    after 4, 8 weeks of treatment

Study Arms (8)

AZM Xmg

ACTIVE COMPARATOR

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

Drug: AZM X mg

AZM X'mg

ACTIVE COMPARATOR

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

Drug: AZM X' mg

AML Ymg

ACTIVE COMPARATOR

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

Drug: AML Y mg

AML Y'mg

ACTIVE COMPARATOR

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

Drug: AML Y' mg

AZM/AML X/Ymg

ACTIVE COMPARATOR

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)

Drug: AZM X mg + AML Y mgDrug: AZM X mgDrug: AML Y mg

AZM/AML X'/Ymg

ACTIVE COMPARATOR

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)

Drug: AZM X' mg + AML Y mgDrug: AZM X' mgDrug: AML Y mg

AZM/AML X/Y'mg

ACTIVE COMPARATOR

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)

Drug: AZM X mg + AML Y' mgDrug: AZM X mgDrug: AML Y' mg

AZM/AML X'/Y'mg

ACTIVE COMPARATOR

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)

Drug: AZM X' mg + AML Y' mgDrug: AZM X' mgDrug: AML Y' mg

Interventions

AZM X' mg + AML Y' mgDRUG

tablet, single dose, QD, oral administration

AZM/AML X'/Y'mg
AZM X' mgDRUG

tablet, single dose, QD, oral administration

AZM X'mgAZM/AML X'/Y'mgAZM/AML X'/Ymg
AML Y' mgDRUG

tablet, single dose, QD, oral administration

AML Y'mgAZM/AML X'/Y'mgAZM/AML X/Y'mg

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celltrion

Incheon, South Korea

Location

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Single-blind Run-in period, Double-blind Treatment period
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2022

First Posted

May 23, 2022

Study Start

July 8, 2022

Primary Completion

July 11, 2024

Study Completion

July 19, 2024

Last Updated

September 11, 2025

Record last verified: 2025-08

Locations

KR(1)