Hypercholesterolemia
Conditions
Brief summary
In the context of australian general practice, to determine the efficacy and safety of ezetimibe 10mg/statin 40mg coadministration in patients with uncontrolled cholesterol receiving statin 40mg or more.
Interventions
DRUGMK0653, ezetimibe / Duration of Treatment: 6 Weeks
Sponsors
Organon and Co
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who will remain on a stable statin dose of 40mg or more, for the duration of the study * Patients with coronary heart disease or diabetes mellitus whose cholesterol levels remain above the initial threshold for government subsidy after at least 3 months of treatment at a daily dose of 40mg or greater of a statin
Exclusion criteria
* Illnesses such as congestive heart failure nyha class iii or iv * Uncontrolled hypertension * Myocardial infarction * Coronary bypass surgery or angioplasty with or without stent within 3 months of the enrolment visit * Unstable angina pectoris or unstable or severe peripheral vascular disease * Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins, ex: type i or type ii diabetes mellitus that is poorly controlled * Serum creatinine \>0.18mmol/l at enrolment or active renal disease with significant proteinuria * Disorders of the haematologic, digestive (including malabsorptive disorders) * Central nervous system including cerebrovascular disease and degenerative diseases that would limit study evaluation or participation * Active acute or chronic hepatobiliary disease * Patients taking the following medication: medications known to interact with statin medication including antifungal azoles, macrolide antibiotics, telithromycin; nefazodone; protease inhibitors; amiodarone; danazol and verapamil; fibrates; cyclosporin * Tg \>4.0mmol/l while using a statin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent (%) reduction in plasma low-density lipoprotein cholesterol (ldl-c) concentration after 6 weeks of treatment | — |
Outcome results
None listed