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New combo pill aims to tackle high blood pressure

NCT ID NCT05385770

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tested whether taking two blood pressure medications (AZM and AML) together works better than taking either one alone. About 890 adults with mild-to-moderate high blood pressure took part. The study lasted 8 weeks and compared different doses of the combination against single drugs.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZM and AML (blood pressure medications)
What this could lead to
If successful, this could offer a more effective two-drug combination for controlling high blood pressure with a single daily pill.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The combination may not be significantly better than each drug alone, and side effects could be higher.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

890 people

The number who actually took part.

Started

Jul 2022

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Celltrion

    Incheon, South Korea

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Other studies related to the condition(s) this trial covers.