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

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ClinicalTrials.gov Identifier: NCT01436253
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : January 22, 2014
Last Update Posted : April 16, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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.

Condition or disease Intervention/treatment
Dyslipidemia Behavioral: Lifestyle Changes Drug: Hypolipemics

Study Type : Observational
Actual Enrollment : 2196 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy
Study Start Date : December 2008
Primary Completion Date : February 2013
Study Completion Date : February 2013

Group/Cohort Intervention/treatment
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.
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.

Primary Outcome Measures :
  1. 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

  2. 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.

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Croatian participants with inadequately controlled hyperlipidemia being treated in the primary care setting

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)

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01436253     History of Changes
Other Study ID Numbers: 0653-179
First Posted: September 19, 2011    Key Record Dates
Results First Posted: January 22, 2014
Last Update Posted: April 16, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases