Phase 4
N=229
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT00442897 ↗Enrolled (actual)
229
Serious AEs
2.4%
Results posted
Nov 2009
Primary outcome: Primary: Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment — 89; 63 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- simvastatin (+) ezetimibe (Drug); Comparator: atorvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reaching the LDL-C (Low Density Lipoprotein-Cholesterol) Goal (< 100 mg/dl) After 6 Weeks of Treatment |
89; 63 | — |
| SECONDARY Number of Participants Reaching the LDL-C Goal (< 100 mg/dl) After 12 Weeks of Treatment |
85; 63 | — |
Summary
Evaluate the proportion of hyperlipaemic persons with known coronary heart disease achieving ldl-c goal as defined by the national cholesterol education program (NCEP) adult treatment panel (ATP) III guidelines
Eligibility Criteria
Inclusion Criteria
- Patients who are naïve to lowering lipid agent
- Patients who are treated with lowering lipid agents and had a wash-out period for 4 weeks.
Exclusion Criteria
- Impaired kidney function
- Increased liver enzyme levels
- Pregnant women
- Hypersensitivity to ezetimibe and other statin agents
Data sourced from ClinicalTrials.gov (NCT00442897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.