DyslipidemiaNCT01436253
Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179)
An observational study of Dyslipidemia, run by Organon and Co.
Trial summary
This study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- Lifestyle Changes and Hypolipemics
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 2,196 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to Feb 2013
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Croatian participants with inadequately controlled hyperlipidemia being treated in the primary care setting
Who may be able to join
- Hyperlipidemic
- On therapy for hyperlipidemia for >=3 months without achieving target lipid values
Who cannot join
- Hypersensitivity or intolerance to hypolipemics
- Significant myopathy or rhabdomiolysis probably caused by hypolipemics
- Uncontrolled endocrine or metabolic disease which is known to affect lipid or lipoprotein values (for example, hypothyroidism and hyperthyroidism)
About this study
Official title: Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy
This study is being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.
- Conditions
- Dyslipidemia
- Being tested
- Lifestyle Changes, Hypolipemics
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle ChangesBehavioural
Diet, increased physical activity, and weight reduction as per European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology were encouraged in addition to pharmacological measures at the discretion of the treating physician.
HypolipemicsDrug
Pharmacological measures at the discretion of the treating physician and in accordance with the respective authorized label and European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology.
| Study group | Role | What they receive |
|---|---|---|
| Croatian participants with hyperlipidemia | Participants being treated in a physician's office for hyperlipidemia who have not achieved target lipid levels on their current hypolipemic therapy. Receives: Behavioral: Lifestyle Changes; Drug: Hypolipemics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Target Lipid Values
Target total cholesterol value was <4.5 mmol/L and target low densisty lipoprotein (LDL) value was <2.5 mmol/L
Measured: Baseline and Month 3
Percentage of Participants With Reduced Cardiovascular Risk
Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; >=17 total points for men, and >=25 total points for women indicates a >=30% risk of developing cardiovascular disease.
Measured: Baseline and Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2011 (estimated)
- Study startDec 2008
- Primary completionFeb 2013
- Study completionFeb 2013
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.
- Other trials for DyslipidemiaStudies 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
- 2,196 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
- NCT01436253
- Sponsor's protocol ID
- 0653-179
- Status last verified
- Feb 2022
- First submitted
- 15 Sep 2011
- Last updated
- 9 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy
- ClinicalTrials.gov ID
- NCT01436253
- Acronym / sponsor ID
- 0653-179
- Conditions
- Dyslipidemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,196 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 19 Sep 2011 (estimated)
- Results
- Posted 22 Jan 2014
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 being done to see whether dietary and medicinal measures compliant with hyperlipidemia treatment guidelines will result in achieving target lipid values and to evaluate the total risk of cardiovascular disease in study participants who have not reached satisfactory lipid levels with their current hypolipemic therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Croatian participants with hyperlipidemia | – | Behavioral: Lifestyle Changes, Drug: HypolipemicsParticipants being treated in a physician's office for hyperlipidemia who have not achieved target lipid levels on their current hypolipemic therapy. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Croatian participants with inadequately controlled hyperlipidemia being treated in the primary care setting
Key inclusion criteria (2 listed)
- Hyperlipidemic
- On therapy for hyperlipidemia for >=3 months without achieving target lipid values
Key exclusion criteria (3 listed)
- Hypersensitivity or intolerance to hypolipemics
- Significant myopathy or rhabdomiolysis probably caused by hypolipemics
- Uncontrolled endocrine or metabolic disease which is known to affect lipid or lipoprotein values (for example, hypothyroidism and hyperthyroidism)
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 |
|---|---|---|
| Lifestyle ChangesDiet, increased physical activity, and weight reduction as per European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology were encouraged in addition to pharmacological measures at the discretion of the treating physician. | Behavioural | Croatian participants with hyperlipidemia |
| HypolipemicsPharmacological measures at the discretion of the treating physician and in accordance with the respective authorized label and European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology. | Drug | Croatian participants with hyperlipidemia |
Primary outcome
Percentage of Participants Achieving Target Lipid Values
Time frame: Baseline and Month 3
Target total cholesterol value was <4.5 mmol/L and target low densisty lipoprotein (LDL) value was <2.5 mmol/L
Percentage of Participants With Reduced Cardiovascular Risk
Time frame: Baseline and Month 3
Cardiovascular risk assessment to determine the 10-year risk for developing cardiovascular disease was done using Framingham risk scoring; categories scored are age, high density lipoprotein (HDL) cholesterol value, total cholesterol value, history of cigarette smoking, and systolic blood pressure. The total of all the points for each risk factor is used to assign a percentage of risk for the occurence of cardiovascular disease within 10 years. Total points for men range from -9 to +37 and for women from -8 to +46; >=17 total points for men, and >=25 total points for women indicates a >=30% risk of developing cardiovascular disease.
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.
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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 Dyslipidemia, 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 2 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 Jan 2014). 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?
Percentage of Participants Achieving Target Lipid Values (time frame: Baseline and Month 3). 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 9 Feb 2022.