HypertensionPACIFNCT07679828
Polypills Approach for Multiple Cardiovascular Risk Factors
A study testing Fixed-Dose Combination Strategy in people with Hypertension and Dyslipidemia, run by China Medical University, China at 15 sites in China.
Trial summary
The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years… Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Hypertension, Dyslipidemia, Diabetes
- What is being tested?
- Fixed-Dose Combination Strategy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,252 participants
- Where
- 15 sitesChina
- Study dates
- 11 Jul 2026to 1 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
China15 sites, 15 recruiting
- Recruiting
Affiliated Hospital of Chifeng University
Chifeng, Inner Mongolia
Xuchen Han, +86 15504766986, hanxuchen2004@163.com
- Not yet recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University
Jinan, Shandong
Xiaoming Zhou, +86 15168887283, sdslyy@yeah.net
- Recruiting
Central Hospital of Jinzhou
Jinzhou, Liaoning
Shuai Jiang, +86 13897854774, 13897854774@163.com
- Not yet recruiting
Kunshan Hospital of Chinese Medicine
Kunshan, Jiangsu
Hengshan Shen, +86 13962637574, 847658065@qq.com
- Not yet recruiting
Panjin Central Hospital
Panjin, Liaoning
Qiong Zhang, +86 15504272626, yoner6789@163.com
- Recruiting
First Hospital of China Medical University
Shenyang, Liaoning, 110001
Guozhe Sun, +86 15040292137, gzhsun66@163.com
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Anhua Wu, +86 18900925766, ahwu@cmu.edu.cn
- Not yet recruiting
Suzhou Wujiang District Hospital of Traditional Chinese Medicine
Suzhou, Jiangsu
Wangfeng Qian, +86 13771692578, wfss873@sina.com
- Not yet recruiting
The Fifth People's Hospital of Wujiang District
Suzhou, Jiangsu
Jun Li, +86 13913731272, lijun19801005@163.com
- Not yet recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Jijun Shi, +86 18934593776, shijijun2008@126.com
- Not yet recruiting
Taixing Second People's Hospital
Taizhou, Jiangsu
Ligong Ji, +86 13815979287, 420643682@qq.com
- Recruiting
Tieling Central Hospital
Tieling, Liaoning
Caixia Yang, +86 13704109696, 2624603253@qq.com
- Recruiting
Tiemei General Hospital of Liaoning Health Industry Group
Tieling, Liaoning
Geng Wang, +86 15542052188, 15542052188@163.com
- Not yet recruiting
Tongliao People's Hospital
Tongliao, Inner Mongolia
Kai Zheng, +86 15004963990, udbmnm2012@163.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan
Xincan Liu, +86 13203825657, Liuxincan103@163.com
About this study
Official title: Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial
The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1. Participants will be further followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and improves cognitive outcomes compared with usual care at Phase 2.
Read the detailed description
The overall objective of the PACIF Trial is to test a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and diabetes. This multicenter randomized controlled trial will evaluate whether a polypill-based approach, compared with usual care, improves cardiovascular risk factor control and reduces cardiovascular disease events among adults with multiple cardiovascular risk factors but without prior cardiovascular disease. The trial will recruit an estimated 8,252 participants aged 50 to <75 years who have hypertension, dyslipidemia, and type 2 diabetes. Participants will be randomly assigned to receive either a fixed-dose combination strategy or usual care.
In the intervention group, the study medication regimen will consist of eight prespecified fixed-dose formulations combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapies. These formulations include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe, and dapagliflozin, with indapamide included in selected formulations. Treatment will be adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. Additional open-label medications may be used according to guideline recommendations and clinical judgment if the prespecified treatment targets are not achieved with the fixed-dose combination strategy. Treatment targets are defined as blood pressure <130/80 mmHg, LDL cholesterol <1.8 mmol/L, and HbA1c <7.0%.
The primary outcome at Phase 1 is the ACC/AHA 10-year cardiovascular disease risk estimated by the PREVENT equations. In addition, changes in PREVENT-estimated 10-year ASCVD and heart failure risk, the proportions of participants achieving the prespecified blood pressure, lipid, and glycemic targets, and changes in individual cardiovascular risk factors will also be evaluated.
The primary outcome at Phase 2 is a composite cardiovascular disease outcome including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization. Cognitive outcomes will also be assessed, with incident all-cause dementia prespecified as a major secondary outcome.
- Conditions
- Hypertension, Dyslipidemia, Diabetes
- Being tested
- Fixed-Dose Combination Strategy
- Keywords
- Hypertension, Dyslipidemia, Diabetes, Polypill, Cardiovascular disease risk, Cardiovascular Diseases, Cognitive function, Randomized controlled trial
- Medical subject headings
- Hypertension, Dyslipidemias, Diabetes Mellitus, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-Dose Combination StrategyDrug
Also called Polypill Strategy
Participants assigned to the intervention group will receive a fixed-dose combination strategy for the integrated control of blood pressure, lipid, and glucose. Eight prespecified fixed-dose formulations will be used, differing in antihypertensive intensity and rosuvastatin dose. All formulations will include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe 10 mg, and dapagliflozin 10 mg, with indapamide 2.5 mg included in selected formulations. The olmesartan medoxomil/amlodipine dose will range from 5/1.25 mg to 20/5 mg, and the rosuvastatin dose will be either 5 mg or 10 mg. Treatment will be selected and adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. If the prespecified blood pressure, lipid, or glycemic targets are not achieved despite the highest fixed-dose regimen, additional open-label medications may be prescribed according to guideline recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Polypill intervention Receives: Drug: Fixed-Dose Combination Strategy |
| Control Group | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-year CVD risk
Changes in 10-year CVD risk estimated by the PREVENT equations
Measured: 12 months
Composite cardiovascular disease outcome
Record the occurrence of the composite cardiovascular disease outcome, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization
Measured: 36 months
Secondary outcomes (30)
Major secondary endpoint: All-cause dementia
Record the occurrence of all-cause dementia
Measured: 36 months
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Measured: 12 months
10-year ASCVD risk
Changes in 10-year ASCVD risk estimated by the PREVENT equations
Measured: 12 months
10-year HF risk
Changes in 10-year HF risk estimated by the PREVENT equations
Measured: 12 months
The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly
The proportions of participants achieving the prespecified targets for blood pressure (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg), LDL-C (<1.8 mmol/L), and HbA1c (<7.0%), individually and jointly
Measured: 12 months
Blood pressure, LDL-C, and HbA1c
Changes in systolic and diastolic blood pressure, LDL-C, and HbA1c
Measured: 12 months
Medication adherence
Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures
Measured: 12 months
Cost-effectiveness
Data on the costs of CVD risk assessment and management will be collected for both study groups. The cost-effectiveness analysis will estimate the incremental cost per unit reduction in estimated 10-year CVD risk in the intervention group compared with the control group.
Measured: 12 months
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Measured: 36 months
The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly
The proportions of participants achieving the prespecified targets for blood pressure (systolic blood pressure <130 mmHg and diastolic blood pressure <80 mmHg), LDL-C (<1.8 mmol/L), and HbA1c (<7.0%), individually and jointly
Measured: 36 months
Blood pressure, LDL-C, and HbA1c
Changes in systolic and diastolic blood pressure, LDL-C, and HbA1c
Measured: 36 months
Composite outcome of composite cardiovascular disease outcome or deaths
Record the occurrence of composite outcome of composite cardiovascular disease outcome or deaths
Measured: 36 months
Macrovascular outcome
Record the occurrence of any of the following: stroke, myocardial infarction, heart failure requiring hospitalization or treatment, aortic dissection, any cardiovascular revascularization procedures, or cardiovascular death
Measured: 36 months
Major coronary artery diseases
Record the occurrence of any of the following: myocardial infarction, revascularization of coronary arteries, or deaths due to coronary artery diseases
Measured: 36 months
Myocardial infarction
Record the occurrence of myocardial infarction
Measured: 36 months
Stroke
Record the occurrence of stroke
Measured: 36 months
Ischemic stroke
Record the occurrence of ischemic stroke
Measured: 36 months
Hemorrhagic stoke
Record the occurrence of hemorrhagic stroke
Measured: 36 months
Heart failure requiring hospitalization or treatment
Record the occurrence of heart failure requiring hospitalization or treatment
Measured: 36 months
Coronary revascularization
Record the occurrence of coronary revascularization
Measured: 36 months
Cardiovascular disease death
Record the occurrence of cardiovascular disease death
Measured: 36 months
All-cause death
Record the occurrence of all-cause death
Measured: 36 months
Microvascular outcomes
Record the occurrence of microvascular complications (e.g., diabetic kidney disease and diabetic peripheral neuropathy)
Measured: 36 months
New-onset chronic kidney disease or progression of chronic kidney disease
Record the occurrence of new-onset chronic kidney disease or progression of chronic kidney disease
Measured: 36 months
Mild cognitive impairment
Record the occurrence of mild cognitive impairment
Measured: 36 months
Composite outcome of dementia and mild cognitive impairment
Record the occurrence of the composite outcome of dementia and mild cognitive impairment
Measured: 36 months
Composite outcome of dementia and all-cause death
Record the occurrence of the composite outcome of dementia and all-cause death
Measured: 36 months
Medication adherence
Medication adherence assessed by participant self-report, pill count, or other prespecified adherence measures
Measured: 36 months
Health related quality of life
Health-related quality of life will be assessed by the Five-Level Version of the EQ-5D (EQ-5D-5L). In this questionnaire, 5 dimensions are measured in 5 items: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. A 5-point Likert scale ranging from "no problems" to "extreme problems" is used for every dimension, with higher scores reflecting more problems in a dimension. A VAS ranging from 0 to 100 (0 = "The best health you can imagine" to 100 = "The worst health you can imagine") is applied as well, with higher scores indicating a better health state as perceived by the patient.
Measured: 36 months
Cost-effectiveness
Cost-effectiveness assessed by the incremental cost-effectiveness ratio, expressed as the incremental cost per quality-adjusted life-year gained. Quality-adjusted life-years will be estimated from health utilities derived using the EQ-5D-5L questionnaire.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start11 Jul 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8,252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guozhe Sun, First Hospital of China Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679828
- Sponsor's protocol ID
- CMU-polypill
- Acronym
- PACIF
- Status last verified
- Sep 2026
- First submitted
- 21 Jun 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polypills Approach for Multiple Cardiovascular Risk Factors (PACIF) : a Multicentre, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07679828
- Acronym / sponsor ID
- PACIF / CMU-polypill
- Conditions
- Hypertension, Dyslipidemia, Diabetes
- Keywords
- Hypertension, Dyslipidemia, Diabetes, Polypill, Cardiovascular disease risk, Cardiovascular Diseases, Cognitive function, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8,252 participants (estimated)
- Lead sponsor
- China Medical University, ChinaUniversity, hospital or other
- Study start
- 11 Jul 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 1 Jul 2026 (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.
The Polypill Approach for Multiple Cardiovascular Risk Factors (PACIF) trial is a multicenter randomized controlled trial that will test the effectiveness and safety of a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and type 2 diabetes among adults aged 50 to 75 years without prior cardiovascular disease in China. The trial will evaluate whether a fixed-dose combination strategy improves the 10-year cardiovascular disease risk estimated using the PREVENT equations at Phase 1. Participants will be further followed to determine whether the fixed-dose combination strategy reduces major cardiovascular events and improves cognitive outcomes compared with usual care at Phase 2.
Detailed description
The overall objective of the PACIF Trial is to test a fixed-dose combination strategy for the integrated management of hypertension, dyslipidemia, and diabetes. This multicenter randomized controlled trial will evaluate whether a polypill-based approach, compared with usual care, improves cardiovascular risk factor control and reduces cardiovascular disease events among adults with multiple cardiovascular risk factors but without prior cardiovascular disease. The trial will recruit an estimated 8,252 participants aged 50 to <75 years who have hypertension, dyslipidemia, and type 2 diabetes. Participants will be randomly assigned to receive either a fixed-dose combination strategy or usual care.
In the intervention group, the study medication regimen will consist of eight prespecified fixed-dose formulations combining blood pressure-lowering, lipid-lowering, and glucose-lowering therapies. These formulations include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe, and dapagliflozin, with indapamide included in selected formulations. Treatment will be adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. Additional open-label medications may be used according to guideline recommendations and clinical judgment if the prespecified treatment targets are not achieved with the fixed-dose combination strategy. Treatment targets are defined as blood pressure <130/80 mmHg, LDL cholesterol <1.8 mmol/L, and HbA1c <7.0%.
The primary outcome at Phase 1 is the ACC/AHA 10-year cardiovascular disease risk estimated by the PREVENT equations. In addition, changes in PREVENT-estimated 10-year ASCVD and heart failure risk, the proportions of participants achieving the prespecified blood pressure, lipid, and glycemic targets, and changes in individual cardiovascular risk factors will also be evaluated.
The primary outcome at Phase 2 is a composite cardiovascular disease outcome including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization. Cognitive outcomes will also be assessed, with incident all-cause dementia prespecified as a major secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Fixed-Dose Combination StrategyPolypill intervention |
| Control Group | No intervention | –Usual care |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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%
Key exclusion criteria (17 listed)
- 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
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 |
|---|---|---|
| Fixed-Dose Combination StrategyAlso: Polypill StrategyParticipants assigned to the intervention group will receive a fixed-dose combination strategy for the integrated control of blood pressure, lipid, and glucose. Eight prespecified fixed-dose formulations will be used, differing in antihypertensive intensity and rosuvastatin dose. All formulations will include olmesartan medoxomil/amlodipine, rosuvastatin, ezetimibe 10 mg, and dapagliflozin 10 mg, with indapamide 2.5 mg included in selected formulations. The olmesartan medoxomil/amlodipine dose will range from 5/1.25 mg to 20/5 mg, and the rosuvastatin dose will be either 5 mg or 10 mg. Treatment will be selected and adjusted among the prespecified fixed-dose formulations according to participants' blood pressure levels, treatment targets, tolerability, and safety. If the prespecified blood pressure, lipid, or glycemic targets are not achieved despite the highest fixed-dose regimen, additional open-label medications may be prescribed according to guideline recommendations. | Drug | Experimental |
Primary outcome
10-year CVD risk
Time frame: 12 months
Changes in 10-year CVD risk estimated by the PREVENT equations
Composite cardiovascular disease outcome
Time frame: 36 months
Record the occurrence of the composite cardiovascular disease outcome, including cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, heart failure requiring hospitalization or treatment, and coronary revascularization
30 secondary outcomes
Major secondary endpoint: All-cause dementia
Time frame: 36 months
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Time frame: 12 months
10-year ASCVD risk
Time frame: 12 months
10-year HF risk
Time frame: 12 months
The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly
Time frame: 12 months
Blood pressure, LDL-C, and HbA1c
Time frame: 12 months
Medication adherence
Time frame: 12 months
Cost-effectiveness
Time frame: 12 months
Hierarchical composite of all-cause mortality, nonfatal cardiovascular events, and improvement in 10-year cardiovascular disease risk estimated by the PREVENT equations
Time frame: 36 months
The proportions of participants achieving the prespecified blood pressure, LDL-C, and HbA1c targets, individually and jointly
Time frame: 36 months
Blood pressure, LDL-C, and HbA1c
Time frame: 36 months
Composite outcome of composite cardiovascular disease outcome or deaths
Time frame: 36 months
Macrovascular outcome
Time frame: 36 months
Major coronary artery diseases
Time frame: 36 months
Myocardial infarction
Time frame: 36 months
Stroke
Time frame: 36 months
Ischemic stroke
Time frame: 36 months
Hemorrhagic stoke
Time frame: 36 months
Heart failure requiring hospitalization or treatment
Time frame: 36 months
Coronary revascularization
Time frame: 36 months
Cardiovascular disease death
Time frame: 36 months
All-cause death
Time frame: 36 months
Microvascular outcomes
Time frame: 36 months
New-onset chronic kidney disease or progression of chronic kidney disease
Time frame: 36 months
Mild cognitive impairment
Time frame: 36 months
Composite outcome of dementia and mild cognitive impairment
Time frame: 36 months
Composite outcome of dementia and all-cause death
Time frame: 36 months
Medication adherence
Time frame: 36 months
Health related quality of life
Time frame: 36 months
Cost-effectiveness
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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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.
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, China
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fixed-Dose Combination Strategy in people with Hypertension and Dyslipidemia, run by China Medical University, China at 15 sites in China.
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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
10-year CVD risk (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.