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

NCT01436253 — Completed, 2196 participants, Organon and Co

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

RegistryNCT01436253
StatusCompleted
Study typeObservational
Enrollment2196 (Actual)
SponsorOrganon and Co (Industry)
ConditionsDyslipidemia
InterventionsLifestyle Changes, Hypolipemics (Behavioral, drug)
Datesstart 2008-12-01, primary completion 2013-02-01, completion 2013-02-01, first posted 2011-09-19, last updated 2022-02-09

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-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.

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+Arms and interventions

ArmTypeInterventionsDescription
Croatian participants with hyperlipidemiaBehavioral: Lifestyle Changes; Drug: HypolipemicsParticipants being treated in a physician's office for hyperlipidemia who have not achieved target lipid levels on their current hypolipemic therapy.
  • 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.

+Outcome measures

Primary outcomes

  • 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.

+Eligibility

Sex: All, ages: 30 Years to any

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)

+Posted results

Participant flow

MilestoneAll Participants
Started2196
Completed1897
Not completed299

Outcome results

  • Percentage of Participants Achieving Target Lipid Values (Primary), Number, Percentage of participants: All Participants 46.8 (44.6 to 49.0)
  • Percentage of Participants With Reduced Cardiovascular Risk (Primary), Number, Percentage of participants: All Participants 51.1

Adverse events

Time frame: Adverse events were collected for up to 3 months, starting with the first visit and ending with the final visit to the Physician's office.

ArmDeathsSerious adverse eventsOther adverse events
All Participants00/2196 (0.0%)0/2196 (0.0%)

My Notes