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One pill to tackle three heart risks: could a polypill cut cardiovascular disease?

NCT ID NCT07679828

Disease control Sponsor: China Medical University, China Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 01, 2026 · Last updated Sep 17, 2026 · Updated 3 times

Summary

This trial tests whether a single daily pill that combines treatments for high blood pressure, high cholesterol, and type 2 diabetes can lower the risk of heart disease and dementia. The study involves over 8,000 adults aged 50 to 75 in China who have all three conditions. Participants receive either the combination pill or their usual separate medications, and researchers track their heart health and cognitive function over time.

What this could mean

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

Active substance
Fixed-dose combination pill (olmesartan medoxomil/amlodipine, rosuvastatin, and glucose-lowering drugs)
What this could lead to
If successful, this simplified daily pill could make it easier for people with multiple risk factors to prevent heart attacks, strokes, and dementia.
What could go wrong
This is a large trial, but the combination pill may cause side effects or not work better than separate medications. Results may not apply to people outside China.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 8,252 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

50 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: * Men or women * Age ≥50 years and \<75 years * Systolic blood pressure ≥130 mmHg * LDL-C ≥1.8 mmol/L (70 mg/dL) * Type 2 diabetes with HbA1c ≥6.5% and \<12% * Willing to participate and able to sign informed consent Exclusion Criteria: * Known secondary cause of hypertension * Type 1 diabetes * Pancreatic insufficiency or diabetes secondary to pancreatitis * Triglycerides ≥5.65 mmol/L (500 mg/dL) * History of myocardial infarction, stroke, or heart failure * History of coronary, cerebrovascular, or peripheral arterial revascularization * Abnormal kidney function, defined as estimated glomerular filtration rate \<30 mL/min/1.73 m² or dialysis * Abnormal liver function, defined as alanine aminotransferase or aspartate aminotransferase \>3 times the upper limit of normal * Abnormal serum potassium, defined as serum potassium \>5.5 mmol/L or \<3.5 mmol/L * Contraindication to any of the components of the polypill * Currently living with another PACIF participant * Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control * Clinical diagnosis of dementia or treatment with medications for dementia * History of malignancy * Life expectancy \<3 years * Currently participating in another intervention study * Any factors judged by the clinic team to be likely to limit adherence to interventions

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diabetes mellitus Dyslipidemias hypertensive disorder inherited lipid metabolism disorder type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes Dyslipidemia Hypertension

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Chifeng University

    RECRUITING

    Chifeng, Inner Mongolia, China

  • Central Hospital of Jinzhou

    RECRUITING

    Jinzhou, Liaoning, China

  • First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110001, China

  • Kunshan Hospital of Chinese Medicine

    NOT_YET_RECRUITING

    Kunshan, Jiangsu, China

  • Panjin Central Hospital

    NOT_YET_RECRUITING

    Panjin, Liaoning, China

  • Shandong Provincial Hospital Affiliated to Shandong First Medical University

    NOT_YET_RECRUITING

    Jinan, Shandong, China

  • Shengjing Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • Suzhou Wujiang District Hospital of Traditional Chinese Medicine

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • Taixing Second People's Hospital

    NOT_YET_RECRUITING

    Taizhou, Jiangsu, China

  • The Fifth People's Hospital of Wujiang District

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Henan University of Chinese Medicine

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • The Second Affiliated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • Tieling Central Hospital

    RECRUITING

    Tieling, Liaoning, China

  • Tiemei General Hospital of Liaoning Health Industry Group

    RECRUITING

    Tieling, Liaoning, China

  • Tongliao People's Hospital

    NOT_YET_RECRUITING

    Tongliao, Inner Mongolia, China

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