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

NCT01436253 | Completed Results

• 1 other identifier: 0653-179
• Study Type: observational
• Target: 2,196
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving Target Lipid Values

  Target total cholesterol value was \<4.5 mmol/L and target low densisty lipoprotein (LDL) value was \<2.5 mmol/L

  Baseline and Month 3

• Percentage of Participants With Reduced Cardiovascular Risk

  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.

  Baseline and Month 3

Study Arms (1)

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; Drug: Hypolipemics

Interventions

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.

Croatian participants with hyperlipidemia

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.

Croatian participants with hyperlipidemia

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Hyperlipidemic
• On therapy for hyperlipidemia for \>=3 months without achieving target lipid values

You may not qualify if:

• 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)

Sponsors & Collaborators

• Organon and Co: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2011
• First Posted: September 19, 2011
• Study Start: December 1, 2008
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 9, 2022
• Results First Posted: January 22, 2014

Record last verified: 2022-02