N/A
N=1,682
Effect of Ezetimibe Treatment on Low-density Lipoprotein Cholesterol (LDL-C) Levels in Participants With Coronary Heart Disease (CHD) Already Treated With a Statin (MK-0653A-205 AM1)
Hypercholesterolemia
Bottom Line
View on ClinicalTrials.gov: NCT01381679 ↗Enrolled (actual)
1,682
Serious AEs
0.2%
Results posted
Mar 2012
Primary outcome: Primary: Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level — 678 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ezetimibe (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Organon and Co
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Achieving Individual LDL Cholesterol (LDL-C) Target Level |
678 | — |
| SECONDARY Change From Baseline in Total Cholesterol (TC) at Month 3 |
-46.6 | — |
| SECONDARY Change From Baseline in TC at Month 12 |
-54.5 | — |
| SECONDARY Change From Baseline in LDL-C at Month 3 |
-41.7 | — |
| SECONDARY Change From Baseline in LDL-C at Month 12 |
-49.3 | — |
| SECONDARY Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C) at Month 3 |
2.8 | — |
| SECONDARY Change From Baseline in HDL-C at Month 12 |
4.0 | — |
| SECONDARY Change From Baseline in Triglycerides (TG) at Month 3 |
-33.8 | — |
| SECONDARY Change From Baseline in TG at Month 12 |
-43.9 | — |
Summary
This non-interventional longitudinal study is a follow-up of the Austrian Cholesterol Screening and Treatment project (ACT I), which assessed the cholesterol status, including achievement of the target levels applicable at that time (LDL levels <100 mg/dL), in participants with coronary heart disease (CHD) already being treated with a statin. In this study, participants without adequate LDL-cholesterol reduction with a statin underwent extension of therapy with ezetimibe with the goal of achieving target levels.
Eligibility Criteria
Inclusion criteria
- Participants in whom LDL-cholesterol target levels have not been achieved.
- Participants in whom a decision has been made by the physician to initiate treatment
with ezetimibe (longitudinal analyses). The treatment decision will be made prior to
and independent from inclusion of participants into this study.
- Participants with LDL cholesterol levels ≤113 mg/dl and a very high risk, which led to case-by-case approval of medication may be documented.
Exclusion criteria
- Any condition which, in the opinion of the treating physician, precludes treatment with ezetimibe.
- In order not to interfere with data collection it is recommended not to include participants currently in a clinical trial.
- Previous and ongoing treatment with ezetimibe.
Data sourced from ClinicalTrials.gov (NCT01381679). 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.