Study of Lipid Control in Hyperlipidemic Participants (MK-0653-179)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: September 15, 2011
Last updated: December 3, 2013
Last verified: December 2013
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.
||Observational Model: Cohort
Time Perspective: Prospective
||Non-Interventional Study In Hyperlipidemic Patients Who Do Not Reach Satisfactory Lipid Values With Existing Hypolipemic Therapy
Primary Outcome Measures:
- Percentage of Participants Achieving Target Lipid Values [ Time Frame: Baseline and Month 3 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2013 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||30 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Croatian participants with inadequately controlled hyperlipidemia being treated in the primary care setting
- On therapy for hyperlipidemia for >=3 months without achieving target lipid values
- 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)
No Contacts or Locations Provided
No publications provided
||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 15, 2011
|Results First Received:
||December 3, 2013
||December 3, 2013
||Croatia: Agency for Medicinal Products and Medical Devices
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Lipid Metabolism Disorders