Coronary Heart DiseaseNCT00723723
Compliance With LDL-Lowering Therapy (Study P05467)(COMPLETED)
An observational study of Coronary Heart Disease and Hypercholesterolemia, run by Organon and Co.
Trial summary
This observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease, Hypercholesterolemia, Hyperlipidemia
- What is being tested?
- Statin
- How many people
- 555 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Jun 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 being treated with a statin for secondary prevention of coronary heart disease
Who may be able to join
- willingness to participate in the study
- 18 years of age or more
- clinically established cardiovascular disease to be considered as patients in secondary prevention
- prior therapy with any statin without achieving goal (2.5 mmol/L of LDL cholesterol) at last lipid check performed
Who cannot join
- None
About this study
Official title: Compliance With LDL-Lowering Therapy For Secondary Prevention of Coronary Heart Disease in Real Life Practice
This observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. Both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.
- Conditions
- Coronary Heart Disease, Hypercholesterolemia, Hyperlipidemia
- Being tested
- Statin
- Medical subject headings
- Coronary Disease, Hypercholesterolemia, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StatinDrug
Statin
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary heart disease | Patients being treated with a statin for secondary prevention of coronary heart disease Receives: Drug: Statin |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients reaching target LDL levels
Measured: 6-8 weeks after first visit and 28-32 weeks after first visit
Secondary outcomes (1)
measure patient compliance to treatment as assessed by counting returned tablets
Measured: 6-8 weeks after first visit and 28-32 weeks after first visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies 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
- 555 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00723723
- Sponsor's protocol ID
- P05467
- Status last verified
- Feb 2022
- First submitted
- 25 Jul 2008
- Last updated
- 16 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance With LDL-Lowering Therapy For Secondary Prevention of Coronary Heart Disease in Real Life Practice
- ClinicalTrials.gov ID
- NCT00723723
- Acronym / sponsor ID
- P05467
- Conditions
- Coronary Heart Disease, Hypercholesterolemia, Hyperlipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 555 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 29 Jul 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 observational study is being conducted in patients receiving statin treatment as secondary prevention of coronary heart disease under the current standard of care in compliance with European guidelines. The purpose of the study is to evaluate the percentage of these patients that reach target LDL levels. Additionally this study will measure the patient's compliance to treatment as assessed by counting the returned tablets. Both assessments will be made at visits conducted 6-8 weeks after the first visit and 28-32 weeks after the first visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary heart disease | – | Drug: StatinPatients being treated with a statin for secondary prevention of coronary heart disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients being treated with a statin for secondary prevention of coronary heart disease
Key inclusion criteria (4 listed)
- willingness to participate in the study
- 18 years of age or more
- clinically established cardiovascular disease to be considered as patients in secondary prevention
- prior therapy with any statin without achieving goal (2.5 mmol/L of LDL cholesterol) at last lipid check performed
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| StatinStatin | Drug | Patients with coronary heart disease |
Primary outcome
percentage of patients reaching target LDL levels
Time frame: 6-8 weeks after first visit and 28-32 weeks after first visit
1 secondary outcome
measure patient compliance to treatment as assessed by counting returned tablets
Time frame: 6-8 weeks after first visit and 28-32 weeks after first visit
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 16 Feb 2022.
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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 Coronary Heart Disease and 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 4 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 16 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?
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?
percentage of patients reaching target LDL levels (time frame: 6-8 weeks after first visit and 28-32 weeks after first visit). 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 16 Feb 2022; AzTrials last refreshed its copy on 29 Oct 2026.