Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)
Phase 3
Completed
- Conditions
- Hypercholesterolemia
- Registration Number
- NCT00092157
- Lead Sponsor
- Organon and Co
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of two approved drugs in lowering high cholesterol when taken together, compared to taking only one of the drugs.
- Detailed Description
The duration of treatment is 12 weeks.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 571
Inclusion Criteria
- Elevated cholesterol level
Exclusion Criteria
- Liver disease
- Known allergies to study drugs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Fasting triglyceride levels at 12 weeks.
- Secondary Outcome Measures
Name Time Method Total Cholesterol, LDL-C, HDL-C, VLDL-C, VLDL-TG, Apo A-I, and Apo B, CRP, PAI-1, fibrinogen, fasting plasma glucose, and fasting insulin
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What are the molecular mechanisms by which simvastatin and fenofibrate synergistically lower LDL-C and increase HDL-C in combined hyperlipidemia?
How does the SAFARI trial compare the efficacy of simvastatin-fenofibrate combination to other statin-fibrate therapies in phase 3 trials?
Which lipid-related biomarkers predict differential response to simvastatin monotherapy versus combination therapy in NCT00092157?
What are the potential adverse event profiles of simvastatin-fenofibrate combination therapy versus monotherapy in hyperlipidemic patients?
How does the simvastatin-fenofibrate regimen in NCT00092157 compare to ezetimibe-based combination therapies for mixed dyslipidemia?