HypercholesterolemiaACT IINCT01381679
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
An observational study of Hypercholesterolemia, run by Organon and Co.
Trial summary
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Ezetimibe
- How many people
- 1,682 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Dec 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants without adequate LDL-cholesterol reduction with a statin, representative cross-section across all regions/parts of Austria (federal provinces, urban/rural areas, office-based internists/general practitioners)
Who may be able to join
- Participants in whom LDL-cholesterol target levels have not been achieved.
- Participants in whom a decision has been made by the physician to initiate treatment
- with ezetimibe (longitudinal analyses). The treatment decision will be made prior to
- and independent from inclusion of participants into this study.
- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.
Who cannot join
- Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.
- In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.
- Previous and ongoing treatment with ezetimibe.
About this study
Official title: Austrian Cholesterol Screening And Treatment II (ACT II)
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EzetimibeDrug
Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.
| Study group | Role | What they receive |
|---|---|---|
| All participants | Participants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen. Receives: Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively
Measured: Up to 12 months
Secondary outcomes (8)
Change From Baseline in Total Cholesterol (TC) at Month 3
Measured: Baseline and Month 3
Change From Baseline in TC at Month 12
Measured: Baseline and Month 12
Change From Baseline in LDL-C at Month 3
Measured: Baseline and Month 3
Change From Baseline in LDL-C at Month 12
Measured: Baseline and Month 12
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3
Measured: Baseline and Month 3
Change From Baseline in HDL-C at Month 12
Measured: Baseline and Month 12
Change From Baseline in Triglycerides (TG) at Month 3
Measured: Baseline and Month 3
Change From Baseline in TG at Month 12
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startMay 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypercholesterolemiaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,682 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381679
- Sponsor's protocol ID
- 0653A-205
- Acronym
- ACT II
- Status last verified
- Feb 2022
- First submitted
- 23 Jun 2011
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pichler M, Lautsch D, Adler C, Bogl K, Drexel H, Eber B, Fauer C, Fochterle J, Foger B, Gansch K, Grafinger P, Lechleitner M, Ludvik B, Maurer G, Morz R, Paulweber B, Pfeiffer KP, Prager R, Stark G, Toplak H, Traindl O, Weitgasser R. Are there differences in LDL-C target value attainment in Austrian federal states? Yes! Wien Med Wochenschr. 2013 Dec;163(23-24):528-35. doi: 10.1007/s10354-013-0219-z. Epub 2013 Aug 27.
PubMed 23979353Eber B, Lautsch D, Fauer C, Drexel H, Pfeiffer KP, Traindl O, Pichler M. Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II. Curr Med Res Opin. 2012 Sep;28(9):1447-54. doi: 10.1185/03007995.2012.717919. Epub 2012 Aug 16.
PubMed 22856551
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Austrian Cholesterol Screening And Treatment II (ACT II)
- ClinicalTrials.gov ID
- NCT01381679
- Acronym / sponsor ID
- ACT II / 0653A-205
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,682 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 22 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants | – | Drug: EzetimibeParticipants in whom LDL-C target levels have not been achieved and for whom ezetimibe therapy has been chosen. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants without adequate LDL-cholesterol reduction with a statin, representative cross-section across all regions/parts of Austria (federal provinces, urban/rural areas, office-based internists/general practitioners)
Key inclusion criteria (5 listed)
- Participants in whom LDL-cholesterol target levels have not been achieved.
- Participants in whom a decision has been made by the physician to initiate treatment
- with ezetimibe (longitudinal analyses). The treatment decision will be made prior to
- and independent from inclusion of participants into this study.
- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.
Key exclusion criteria (3 listed)
- Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.
- In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.
- Previous and ongoing treatment with ezetimibe.
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 |
|---|---|---|
| EzetimibeEzetimibe was not mandatory and was prescribed as per routine prescription by physician. | Drug | All participants |
Primary outcome
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level
Time frame: Up to 12 months
Individual LDL-C target values were set according to the Austrian Cholesterol Consensus (ACC) 2007 for patients for patients suffering from coronary heart disease (CHD) or CHD equivalent in an office-based, routine medical care setting. Participants were categorized as either high-risk or very high-risk based on ACC criteria. The LDL-C target levels for each category were 100 mg/dL and 70 mg/dL, respectively
8 secondary outcomes
Change From Baseline in Total Cholesterol (TC) at Month 3
Time frame: Baseline and Month 3
Change From Baseline in TC at Month 12
Time frame: Baseline and Month 12
Change From Baseline in LDL-C at Month 3
Time frame: Baseline and Month 3
Change From Baseline in LDL-C at Month 12
Time frame: Baseline and Month 12
Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3
Time frame: Baseline and Month 3
Change From Baseline in HDL-C at Month 12
Time frame: Baseline and Month 12
Change From Baseline in Triglycerides (TG) at Month 3
Time frame: Baseline and Month 3
Change From Baseline in TG at Month 12
Time frame: Baseline and Month 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23979353Pichler M, Lautsch D, Adler C, Bogl K, Drexel H, Eber B, Fauer C, Fochterle J, Foger B, Gansch K, Grafinger P, Lechleitner M, Ludvik B, Maurer G, Morz R, Paulweber B, Pfeiffer KP, Prager R, Stark G, Toplak H, Traindl O, Weitgasser R. Are there differences in LDL-C target value attainment in Austrian federal states? Yes! Wien Med Wochenschr. 2013 Dec;163(23-24):528-35. doi: 10.1007/s10354-013-0219-z. Epub 2013 Aug 27.
- Derived from this study: PubMed 22856551Eber B, Lautsch D, Fauer C, Drexel H, Pfeiffer KP, Traindl O, Pichler M. Can LDL-cholesterol targets be achieved in a population at high risk? Results of the non-interventional study ACT II. Curr Med Res Opin. 2012 Sep;28(9):1447-54. doi: 10.1185/03007995.2012.717919. Epub 2012 Aug 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Organon and Co.
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 5 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 22 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01381679, which also lists 2 linked publications.
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 9 Feb 2022.