HyperlipidemiaCRE NISNCT00781560
Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and Rate of Patients Achieving the Treatment Goal
An observational study of Hyperlipidemia, run by AstraZeneca at 15 sites in China.
Trial summary
This study is designed to survey the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists; To survey the control rate of the patients with dyslipidemia in "real world"; and to evaluate the percentage of hyperlipidemia patients who achieved target LDL-C level according to the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemia
- How many people
- 2,575 participants
- Where
- 15 sitesChina
- Study dates
- Oct 2008to Jul 2009
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who has been diagnosed as hypercholesterolemia and decided by physician to use Crestor® 5mg or 10mg or other regimens (TLC or other lipid-lowering agents)
Who may be able to join
- Diagnosed as dyslipidemia by doctors
- Having lipids test and record within one months
- Diagnosed as hypercholesterolemia or mixed dyslipidaemias and has been prescribed Crestor® 5mg or 10mg
Who cannot join
- Unable or unwilling to provide the Inform Consent
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Research Site
Beijing, Beijing Municipality
Research Site
Chengdu, Sichuan
Research Site
Chenzhen, Guangdong
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Harbin, Heilongjiang
Research Site
Jinan, Shandong
Research Site
Nanjing, Jiangsu
Reseearch Site
Ningbo, Zhejiang
Research Site
Qingdao, Shandong
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Tianjin, Tianjin Municipality
Research Site
Xi’an, Shanxi
Research Site
Zhengzhou, Henan
About this study
Official title: A Cross-sectional Study to Survey the Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and the Rate of Patients (on Treatment) Achieving the Hyperlipidaemia Treatment Goal With Crestor 5mg to 10mg for 8 Weeks
This study is designed to survey the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists; To survey the control rate of the patients with dyslipidemia in "real world"; and to evaluate the percentage of hyperlipidemia patients who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007) following 8-week treatment by Crestor® 5mg or 10mg
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, Chinese National Adult Lipid Treatment Guideline (2007), Crestor®
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | patients being diagnosed as dyslipidemia but not receiving Crestor® | |
| 2 | hypercholesterolemia or mixed dyslipidemia and have been initiated treatment with Crestor® |
What is being measured
The primary outcome is the main question the study is designed to answer.
the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists
Measured: 1 time
the control rate of patients reaching target LDL-C level
Measured: 8 weeks
Secondary outcomes (2)
the percent change from baselines in TC, TG, HDL-C
Measured: 8 weeks
the percentage of hyperlipidemia patients in different risk categories who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startOct 2008
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,575 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Karen Atkin, Study director, Astrazeneca China R&DZhu Junren, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781560
- Sponsor's protocol ID
- NIS-CCN-CRE-2008/1
- Acronym
- CRE NIS
- Status last verified
- Aug 2009
- First submitted
- 28 Oct 2008
- Last updated
- 7 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study to Survey the Awareness of Chinese National Adult Lipid Treatment Guideline (2007) and the Rate of Patients (on Treatment) Achieving the Hyperlipidaemia Treatment Goal With Crestor 5mg to 10mg for 8 Weeks
- ClinicalTrials.gov ID
- NCT00781560
- Acronym / sponsor ID
- CRE NIS / NIS-CCN-CRE-2008/1
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, Chinese National Adult Lipid Treatment Guideline (2007), Crestor®
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,575 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Study completion
- Jul 2009 (actual)
- First posted
- 29 Oct 2008 (estimated)
- 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 survey the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists; To survey the control rate of the patients with dyslipidemia in "real world"; and to evaluate the percentage of hyperlipidemia patients who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007) following 8-week treatment by Crestor® 5mg or 10mg
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –patients being diagnosed as dyslipidemia but not receiving Crestor® |
| 2 | – | –hypercholesterolemia or mixed dyslipidemia and have been initiated treatment with Crestor® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who has been diagnosed as hypercholesterolemia and decided by physician to use Crestor® 5mg or 10mg or other regimens (TLC or other lipid-lowering agents)
Key inclusion criteria (3 listed)
- Diagnosed as dyslipidemia by doctors
- Having lipids test and record within one months
- Diagnosed as hypercholesterolemia or mixed dyslipidaemias and has been prescribed Crestor® 5mg or 10mg
Key exclusion criteria (1 listed)
- Unable or unwilling to provide the Inform Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists
Time frame: 1 time
the control rate of patients reaching target LDL-C level
Time frame: 8 weeks
2 secondary outcomes
the percent change from baselines in TC, TG, HDL-C
Time frame: 8 weeks
the percentage of hyperlipidemia patients in different risk categories who achieved target LDL-C level according to the Chinese National Adult Lipid Treatment Guideline (2007)
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2009.
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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.
Karen Atkin study director
Astrazeneca China R&D
Zhu Junren principal investigator
Fudan University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemia, run by AstraZeneca 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 7 Aug 2009. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the awareness rate of Chinese National Adult Lipid Treatment Guideline (2007) by cardiologists (time frame: 1 time). 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 7 Aug 2009.