Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179)

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.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Hyperlipidemic
On therapy for hyperlipidemia for >=3 months without achieving target lipid values

Exclusion criteria

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)

Treatment and study plan

lifestyle changes

Behavioral

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.

Hypolipemics

Drug

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Organon and Co

Industry

Registry information

Official study title

Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy

Important dates

Study start: 2008
Primary completion: 2013
Study completion: 2013
First posted: Sep 19, 2011
Registry last updated: Feb 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed