New combo pill aims to tackle high blood pressure
NCT ID NCT05385770
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
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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
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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 Hide 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.
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