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

Dyslipidemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436253
• Other study ID #: 0653-179
• Status: Completed
• Start date: December 2008
• Est. completion date: February 2013

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 hypolipemic therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2196
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias

Intervention

Behavioral:
• Lifestyle Changes
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.

Drug:
• Hypolipemics
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Organon and Co

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and Month 3
Primary	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.	Baseline and Month 3