HypercholesterolemiaREVORUTIONNCT00526721
Real-life EValuation Of High Dose RosUvastatin in High Risk Patients After TitraTION
An observational study of Hypercholesterolemia, run by AstraZeneca at 3 sites in South Korea.
Trial summary
To evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with high risk after high dose rosuvastatin(20mg/day) titration Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia
- How many people
- 1,482 participants
- Where
- 3 sitesSouth Korea
- Study dates
- May 2007to Apr 2008
- 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: Hypercholesteromia patients with high risk according to NCEP ATP III guideline in Korean tertiary care centers
Who may be able to join
- High-risk hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on the physician's clinical decision and fulfill the following criteria
- Over 18 years of age
- Have history of CHD or CHD risk equivalents, such as peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease (TIA or stroke of carotid origin or >50% obstruction of carotid artery), DM, and 2+ risk factors with 10-year risk CHD>20%
Who cannot join
- Patients already taking other hyperlipidemic agents
- Patients who do not fulfil the indication criteria for statin therapy
- Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
Research Site
Seoul, Jongro-gu
Research Site
Seoul, Kangnam-gu
Research Site
Seoul, Songpa-gu
About this study
Official title: An Observational, Non-interventional, Multi-center Study to Evaluate Efficacy and Tolerability of High Dose Rosuvastatin in High Risk Patients After Titration
To evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with high risk after high dose rosuvastatin(20mg/day) titration
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Crestor, LDL target goal, high risk patients, Naturalistic, Observational
- Medical subject headings
- Hypercholesterolemia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2007 (estimated)
- Study startMay 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,482 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyunah Caroline Choi, Study director, AstraZeneca Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00526721
- Sponsor's protocol ID
- NIS-CKR-CRE-2007/6
- Acronym
- REVORUTION
- Status last verified
- Mar 2012
- First submitted
- 5 Sep 2007
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Non-interventional, Multi-center Study to Evaluate Efficacy and Tolerability of High Dose Rosuvastatin in High Risk Patients After Titration
- ClinicalTrials.gov ID
- NCT00526721
- Acronym / sponsor ID
- REVORUTION / NIS-CKR-CRE-2007/6
- Conditions
- Hypercholesterolemia
- Keywords
- Hypercholesterolemia, Crestor, LDL target goal, high risk patients, Naturalistic, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,482 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 10 Sep 2007 (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 evaluate achievement ratio of treatment target goal in hypercholesterolemia patients with high risk after high dose rosuvastatin(20mg/day) titration
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hypercholesteromia patients with high risk according to NCEP ATP III guideline in Korean tertiary care centers
Key inclusion criteria (3 listed)
- High-risk hyperlipidemia patients who are prescribed with rosuvastatin 10mg, based on the physician's clinical decision and fulfill the following criteria
Key exclusion criteria (3 listed)
- Patients already taking other hyperlipidemic agents
- Patients who do not fulfil the indication criteria for statin therapy
- Patients who do not have baseline and/or follow-up lipid data to verify the efficacy data
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 20 Mar 2012.
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Not yet recruiting
Penn Family Screening for Familial Hypercholesterolemia (NHLBI R33) Trial 3
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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.
Hyunah Caroline Choi study director
AstraZeneca Korea
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by AstraZeneca at 3 sites in South Korea.
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 3 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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 20 Mar 2012.