Essential HypertensionPhase 3NCT05385770

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

A Phase 3 study testing AZM X mg + AML Y mg, AZM X mg + AML Y' mg and AZM X' mg + AML Y mg in people with Essential Hypertension, run by Celltrion at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 19 to 75 years
Conditions the study is for: Essential Hypertension
What is being tested?: AZM X mg + AML Y mg, AZM X mg + AML Y' mg and AZM X' mg + AML Y mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 890 participants
Where: 1 siteSouth Korea
Study dates: 8 Jul 2022to 19 Jul 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Celltrion
Incheon

Other trials in South Korea

About this study

Official title: 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

Conditions: Essential Hypertension
Being tested: AZM X mg + AML Y mg, AZM X mg + AML Y' mg, AZM X' mg + AML Y mg, AZM X' mg + AML Y' mg, AZM X mg
Medical subject headings: Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AZM X mg + AML Y mgDrug
tablet, single dose, QD, oral administration
AZM X mg + AML Y' mgDrug
tablet, single dose, QD, oral administration
AZM X' mg + AML Y mgDrug
tablet, single dose, QD, oral administration
AZM X' mg + AML Y' mgDrug
tablet, single dose, QD, oral administration
AZM X mgDrug
tablet, single dose, QD, oral administration
AZM X' mgDrug
tablet, single dose, QD, oral administration
AML Y mgDrug
tablet, single dose, QD, oral administration
AML Y' mgDrug
tablet, single dose, QD, oral administration

Study groups in NCT05385770
Study group	Role	What they receive
AZM Xmg	Active comparator	1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg (8 weeks) Receives: Drug: AZM X mg
AZM X'mg	Active comparator	1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg (8 weeks) Receives: Drug: AZM X' mg
AML Ymg	Active comparator	1. AML Ymg (4 weeks) Non-responder -> AML Ymg (8 weeks) Receives: Drug: AML Y mg
AML Y'mg	Active comparator	1. AML Y'mg (4 weeks) Non-responder -> AML Y'mg (8 weeks) Receives: 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) Receives: Drug: AZM X mg + AML Y mg; Drug: AZM X mg; Drug: 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) Receives: Drug: AZM X' mg + AML Y mg; Drug: AZM X' mg; Drug: 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) Receives: Drug: AZM X mg + AML Y' mg; Drug: AZM X mg; Drug: 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) Receives: Drug: AZM X' mg + AML Y' mg; Drug: AZM X' mg; Drug: AML Y' mg

What is being measured

The primary outcome is the main question the study is designed to answer.

msitSBP
msitSBP change from baseline
Measured: after 8 weeks of treatment

Secondary outcomes (5)

msitDBP
msitDBP change from baseline
Measured: after 8 weeks of treatment
msitSBP
msitSBP change from baseline
Measured: after 4 weeks of treatment
msitDBP
msitDBP change from baseline
Measured: after 4 weeks of treatment
Proportion of subjects achieving msitSBP < 140 mmHg and/or ΔmsitSBP ≥ 20 mmHg
Measured: after 4, 8 weeks of treatment
Proportion of subjects achieving msitDBP < 90 mmHg and/or ΔmsitDBP ≥ 10 mmHg
Measured: after 4, 8 weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 202219 Jul 2024

First posted23 May 2022
Study start8 Jul 2022
Primary completion11 Jul 2024
Study completion19 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Essential HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 890 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05385770
Sponsor's protocol ID: CT-L05-301
Status last verified: Aug 2025
First submitted: 18 May 2022
Last updated: 11 Sep 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT05385770
Acronym / sponsor ID: CT-L05-301
Conditions: Essential Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 890 participants (actual)
Lead sponsor: CelltrionIndustry (pharma, biotech, devices)
Study start: 8 Jul 2022 (actual)
Primary completion: 11 Jul 2024 (actual)
Study completion: 19 Jul 2024 (actual)
First posted: 23 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
AZM Xmg	Active comparator	Drug: AZM X mg1. AZM Xmg (4 weeks) Non-responder -> AZM Xmg (8 weeks)
AZM X'mg	Active comparator	Drug: AZM X' mg1. AZM X'mg (4 weeks) Non-responder -> AZM X'mg (8 weeks)
AML Ymg	Active comparator	Drug: AML Y mg1. AML Ymg (4 weeks) Non-responder -> AML Ymg (8 weeks)
AML Y'mg	Active comparator	Drug: AML Y' mg1. AML Y'mg (4 weeks) Non-responder -> AML Y'mg (8 weeks)
AZM/AML X/Ymg	Active comparator	Drug: AZM X mg + AML Y mg, Drug: AZM X mg, Drug: AML Y mg1. 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)
AZM/AML X'/Ymg	Active comparator	Drug: AZM X' mg + AML Y mg, Drug: AZM X' mg, Drug: AML Y mg1. 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)
AZM/AML X/Y'mg	Active comparator	Drug: AZM X mg + AML Y' mg, Drug: AZM X mg, Drug: AML Y' mg1. 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)
AZM/AML X'/Y'mg	Active comparator	Drug: AZM X' mg + AML Y' mg, Drug: AZM X' mg, Drug: AML Y' mg1. 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)

Who may qualify

Ages: 19 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AZM X mg + AML Y mgtablet, single dose, QD, oral administration	Drug	AZM/AML X/Ymg
AZM X mg + AML Y' mgtablet, single dose, QD, oral administration	Drug	AZM/AML X/Y'mg
AZM X' mg + AML Y mgtablet, single dose, QD, oral administration	Drug	AZM/AML X'/Ymg
AZM X' mg + AML Y' mgtablet, single dose, QD, oral administration	Drug	AZM/AML X'/Y'mg
AZM X mgtablet, single dose, QD, oral administration	Drug	AZM Xmg, AZM/AML X/Y'mg, AZM/AML X/Ymg
AZM X' mgtablet, single dose, QD, oral administration	Drug	AZM X'mg, AZM/AML X'/Y'mg, AZM/AML X'/Ymg
AML Y mgtablet, single dose, QD, oral administration	Drug	AML Ymg, AZM/AML X'/Ymg, AZM/AML X/Ymg
AML Y' mgtablet, single dose, QD, oral administration	Drug	AML Y'mg, AZM/AML X'/Y'mg, AZM/AML X/Y'mg

Primary outcome

msitSBP
Time frame: after 8 weeks of treatment
msitSBP change from baseline

5 secondary outcomes

msitDBP
Time frame: after 8 weeks of treatment
msitSBP
Time frame: after 4 weeks of treatment
msitDBP
Time frame: after 4 weeks of treatment
Proportion of subjects achieving msitSBP < 140 mmHg and/or ΔmsitSBP ≥ 20 mmHg
Time frame: after 4, 8 weeks of treatment
Proportion of subjects achieving msitDBP < 90 mmHg and/or ΔmsitDBP ≥ 10 mmHg
Time frame: after 4, 8 weeks of treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.

Related trials for Essential Hypertension

Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
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Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing AZM X mg + AML Y mg, AZM X mg + AML Y' mg and AZM X' mg + AML Y mg in people with Essential Hypertension, run by Celltrion at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

msitSBP (time frame: after 8 weeks of treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05385770.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.