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

Completed

• Conditions: Dyslipidemia
• Interventions: Behavioral: Lifestyle Changes; Drug: Hypolipemics

• Registration Number: NCT01436253
• Lead Sponsor: Organon and Co

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2011-09-15
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-19
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Results First Submitted: 2013-12-03
• Results First Submitted QC: 2013-12-03
• Results First Posted: 2014-01-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Croatian participants with hyperlipidemia	Lifestyle Changes	Participants being treated in a physician's office for hyperlipidemia who have not achieved target lipid levels on their current hypolipemic therapy.
Croatian participants with hyperlipidemia	Hypolipemics	Participants being treated in a physician's office for hyperlipidemia who have not achieved target lipid levels on their current hypolipemic therapy.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Target Lipid Values	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	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.