DyslipidemiasPhase 4NCT03418974
Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia
A Phase 4 study testing Pitavastatin, Atorvastatin and Rosuvastatin in people with Dyslipidemias, run by Fudan University at 2 sites in China.
Trial summary
This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- Pitavastatin, Atorvastatin and Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Nov 2017to 31 Dec 2021
- Phase
- Phase 4
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
- ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
- Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.
Who cannot join
- Patients with any allergy to statins;
- ACS patients in acute stage；
- Patients with severe liver disease or biliary obstruction；
- Patients taking cyclosporine；
- Patients who have being treated with statins currently or in the past;
- Pregnant or lactating women and those women who planning to be pregnant;
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- Immunodeficiency or Immunocompromised patients;
- Patients with hypothyroidism (expect those patients whose thyroid function returned to normal level after drug therapy);
- Patients using systemic hormone drug;
- Researchers decided that the patients who was not suitable to participate in the study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Heart Center of Peking University People's Hospital
Beijing, Beijing Municipality, 100044
School of Public Health, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study
This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.
Read the detailed description
Study Objective:
- The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population;
- The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients.
Study Design: The study was an open-label, multi-center network register-based follow-up study.
The total sample size: 10000 participants.
- Conditions
- Dyslipidemias
- Being tested
- Pitavastatin, Atorvastatin, Rosuvastatin
- Keywords
- Dyslipidemia, Cardiovascular Diseases, Hypertension, LDL-C
- Medical subject headings
- Dyslipidemias, Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PitavastatinDrug
Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
AtorvastatinDrug
Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
RosuvastatinDrug
Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Pitavastatin treatment | Experimental | The drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd.. Receives: Drug: Pitavastatin |
| Atorvastatin treatment | Experimental | The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified. Receives: Drug: Atorvastatin |
| Rosuvastatin treatment | Experimental | The drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified. Receives: Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C target achieving rate
To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate.
Measured: 3 months
Secondary outcomes (10)
Blood lipid parameters
The levels of total cholesterol (TC) in mmol/L
Measured: 3 months
Blood lipid parameters
The levels of triglyceride (TG) in mmol/L
Measured: 3 months
Blood lipid parameters
The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L
Measured: 3 months
Blood glucose levels
To measure the level of glycosylated hemoglobin (HbA1) in percent (%)
Measured: 1 year
Fasting blood glucose
The levels of fasting blood glucose (FBG) in mmol/L
Measured: 1 year
Blood lipid parameters
The levels of total cholesterol (TC) in mmol/L
Measured: 1 year
Blood lipid parameters
The levels of triglyceride (TG) in mmol/L
Measured: 1 year
Blood lipid parameters
The levels of low density lipoprotein cholesterol (LDL-C) in mmol/L
Measured: 1 year
Blood lipid parameters
The levels of High density lipoprotein cholesterol (HDL-C) in mmol/L
Measured: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To evaluate the safety and tolerability of the three statins, the incidence of treatment-emergent adverse events should be recorded though the study.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study start1 Nov 2017
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital, Jiangsu Wanbang Medicine Marketing Co., Ltd.
- Responsible party
- Principal investigator, Jinming Yu, Fudan University
- Investigators
- Yuming Jin, Professor, Principal investigator, School of Public Health，Fudan UniversityDayi Hu, Professor, Principal investigator, Director of Department of Cardiology, Peking University People's Hospital; Director of Institute of Cardiovascular Disease, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03418974
- Sponsor's protocol ID
- BZ1701
- Status last verified
- Jan 2018
- First submitted
- 14 Jan 2018
- Last updated
- 1 Feb 2018
- 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 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Statins for Chinese Patients With Dyslipidemia: A Network Register-based Follow-up Study
- ClinicalTrials.gov ID
- NCT03418974
- Acronym / sponsor ID
- BZ1701
- Conditions
- Dyslipidemias
- Keywords
- Dyslipidemia, Cardiovascular Diseases, Hypertension, LDL-C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Peking University People's Hospital, Jiangsu Wanbang Medicine Marketing Co., Ltd.
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 1 Feb 2018 (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.
This study is designed to verify the clinical efficacy and safety of different statins in dyslipidemia patients, and explore the effects on glycometabolic in patients with impaired glucose regulation.
Detailed description
Study Objective:
- The main Objective: To explore the effects of different statins lipid-lowering treatment on glucose metabolism in patients with impaired glucose regulation in a large sample of Chinese population;
- The secondary Objective: To obtain real-world evidence of the clinical efficacy and safety of statins lipid-lowering therapy in Chinese patients.
Study Design: The study was an open-label, multi-center network register-based follow-up study.
The total sample size: 10000 participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants are assigned to one of two or more groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Pitavastatin treatment | Experimental | Drug: PitavastatinThe drug pitavastatin is given to the patient according to the doctor's order and restricted to BangZhi produced by Jiangsu Wanbang Medicine Marketing Co., Ltd.. |
| Atorvastatin treatment | Experimental | Drug: AtorvastatinThe drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified. |
| Rosuvastatin treatment | Experimental | Drug: RosuvastatinThe drug atorvastatin is given to the patient according to the doctor's order and the drug band is unspecified. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a clinical diagnosis of ASCVD (Acute coronary syndrome, Stable coronary heart disease, Postoperative revascularization, Ischemic cardiomyopathy, Ischemic stroke, Transient ischemic attack, Peripheral atherosclerotic disease).
- ASCVD overall risk assessment for high-risk groups: Diabetic patients with LDL-C≥1.8mmol/L（70mg/dl）and age was equal or greater than 40 years old;
- Patients with hypertension, LDL-C > 2.6mmol/L (100mg/dL) and combined with at least two risk factors. Risk factors include smoking, low HDL-C (HDL-C<1mmol/L, 40mg/dL), male aged over 45 years old or female aged over 55 years old; *** The above (1)-(3) are juxtapositions, patients can be included into the group if only they are satisfied with at least one of the inclusion criteria.
Key exclusion criteria (10 listed)
- Patients with any allergy to statins;
- ACS patients in acute stage；
- Patients with severe liver disease or biliary obstruction；
- Patients taking cyclosporine；
- Patients who have being treated with statins currently or in the past;
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 |
|---|---|---|
| PitavastatinCapsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks. | Drug | Pitavastatin treatment |
| AtorvastatinCapsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks. | Drug | Atorvastatin treatment |
| RosuvastatinCapsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks. | Drug | Rosuvastatin treatment |
Primary outcome
LDL-C target achieving rate
Time frame: 3 months
To measure the levels of LDL-C in mmol/L and calculate the LDL-C target achieving rate.
10 secondary outcomes
Blood lipid parameters
Time frame: 3 months
Blood lipid parameters
Time frame: 3 months
Blood lipid parameters
Time frame: 3 months
Blood glucose levels
Time frame: 1 year
Fasting blood glucose
Time frame: 1 year
Blood lipid parameters
Time frame: 1 year
Blood lipid parameters
Time frame: 1 year
Blood lipid parameters
Time frame: 1 year
Blood lipid parameters
Time frame: 1 year
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- 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. This study is not recruiting at the moment.
Yuming Jin, Professor principal investigator
School of Public Health，Fudan University
Dayi Hu, Professor principal investigator
Director of Department of Cardiology, Peking University People's Hospital; Director of Institute of Cardiovascular Disease, Peking University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Pitavastatin, Atorvastatin and Rosuvastatin in people with Dyslipidemias, run by Fudan University at 2 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
LDL-C target achieving rate (time frame: 3 months). 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 1 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.