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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01436253
First received: September 15, 2011
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

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 Intervention
Dyslipidemia
Behavioral: Lifestyle Changes
Drug: Hypolipemics

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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.


Enrollment: 2196
Study Start Date: December 2008
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Croatian participants with inadequately controlled hyperlipidemia being treated in the primary care setting

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01436253     History of Changes
Other Study ID Numbers: 0653-179
Study First Received: September 15, 2011
Results First Received: December 3, 2013
Last Updated: August 7, 2014
Health Authority: Croatia: Agency for Medicinal Products and Medical Devices

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on September 14, 2014