HealthyNCT00680082
Observational Usage Study of Statins in Primary Care in France
An observational study of Healthy, run by AstraZeneca at 25 sites in China.
Trial summary
To describe the way statins are used in France in primary care, that is to determine patients profile (particularly CV risk factors), to determine the way statins are initiated by general practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 2,100 participants
- Where
- 25 sitesChina
- Study dates
- Feb 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients recruited by a GP, community sample
Who may be able to join
- Patients to whom a statin was initiated or switched between 3 and 6 months before consultation
Who cannot join
None listed.
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Research Site
Changsha, Hunan
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Fuzhou, Fujian
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Hefei, Anhui
Research Site
Jinan, Shandong
Research Site
Kunming, Yunnan
Research Site
Nanchang, Jiangxi
Research Site
Nanjing, Jiangsu
Research Site
Ningbo, Zhejiang
Research Site
Qingdao, Shandong
Research Site
Rui’an, Zhejiang
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenzhen, Guangdong
Research Site
Suzhou, Jiangsu
Research Site
Taiyuan, Shanxi
Research Site
Wenzhou, Zhejiang
Research Site
Wuhan, Hubei
Research Site
Wuxi, Jiangsu
Research Site
Xi’an, Shanxi
Research Site
Xiamen, Guangdong
Research Site
Zhengzhou, Henan
Research Site
Zhongshan, Guangdong
About this study
To describe the way statins are used in France in primary care, that is to determine patients profile (particularly CV risk factors), to determine the way statins are initiated by general practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin
- Conditions
- Healthy
- Keywords
- statins, rosuvastatin, cross sectional study, France, CV risk factors
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 to whom a statin was initiated or switched between 3 and 6 months before consultation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startFeb 2008
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 2,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Francois Morand, Principal investigator, Cegedim Strategic Data - Boulogne Billancourt - FranceJean Dallongeville, Study chair, Institut Pasteur - Inserm U744 - Lille -France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680082
- Sponsor's protocol ID
- NIS-CFR-CRE-2007/2
- Status last verified
- Dec 2010
- First submitted
- 15 May 2008
- Last updated
- 2 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Usage Study of Statins in Primary Care in France
- ClinicalTrials.gov ID
- NCT00680082
- Acronym / sponsor ID
- NIS-CFR-CRE-2007/2
- Conditions
- Healthy
- Keywords
- statins, rosuvastatin, cross sectional study, France, CV risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,100 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 19 May 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.
To describe the way statins are used in France in primary care, that is to determine patients profile (particularly CV risk factors), to determine the way statins are initiated by general practitioners, to evaluate aftercare and to assess patients treated by rosuvastatin
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients to whom a statin was initiated or switched between 3 and 6 months before consultation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients recruited by a GP, community sample
Key inclusion criteria (1 listed)
- Patients to whom a statin was initiated or switched between 3 and 6 months before consultation
Key exclusion criteria (0 listed)
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
Not reported in the source record.
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 2 Dec 2010.
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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.
Francois Morand principal investigator
Cegedim Strategic Data - Boulogne Billancourt - France
Jean Dallongeville study chair
Institut Pasteur - Inserm U744 - Lille -France
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by AstraZeneca at 25 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 1 inclusion and 0 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 2 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 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.
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 2 Dec 2010.