Clinical trial NCT00653835: Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
Official title: SCH 58235: A Multicenter, Randomised, Parallel Groups, Placebo-Controlled Study Comparing The Efficacy, Safety, and Tolerability Of The Daily Co-Administration of Ezetimibe 10 mg With Simvastatin 20 mg vs Ezetimibe Placebo With Simvastatin 20 mg in Untreated Subjects With Primary Hypercholesterolaemia And Coronary Heart Disease (Protocol P03435)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolaemia
Atherosclerosis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2008-04-07
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess whether co-administration of ezetimibe 10 mg with simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in reducing LDL-C concentrations when administered for 6 weeks.


Eligibility criteria: Inclusion Criteria:

* \>=18 years and \<= 75 years of age
* LDL-C concentration \>= 3.3 mmol/L (130 mg/dL) to \<= 4.9 mmol/L (190 mg/dL) at baseline.
* Triglyceride concentration \<3.99 mmol/L (350 mg/dL) at baseline.
* Documented coronary heart disease (CHD), which will include one or more of the following features: documented stable angina (with evidence of ischemia on exercise testing); history of MI; history of PCI (primarily PTCA with or without stent replacement); symptomatic peripheral vascular disease; documented history of atherothrombotic cerebrovascular disease; and/or documented history of non-Q wave MI.
* Stable weight history for at least 4 weeks prior to entry into study at baseline.
* Female subjects of childbearing potential must be using an acceptable method of birth control or be surgically sterilized.

Exclusion Criteria:

* Body mass index (BMI) \>=35 kg/m\^2 at baseline.
* Subjects whose liver transaminases (ALT, AST) are \>1.5 times the upper limit of normal and with active liver diseases at baseline.
* Subjects with evidence of current myopathy (including subjects with CK\>1.5 times above the upper limit of normal) at baseline.
* Subjects with clinical laboratory tests (CBC, blood chemistries, urinalysis) outside the normal range that are clinically acceptable to the investigator at baseline.
* Subjects with Type II diabetes mellitus who are poorly controlled (HbA1c\>9%) or newly diagnosed (within 3 months) or who have had a change in anti-diabetic therapy within 3 months of baseline.
* Subjects with Type I diabetes mellitus who have not been on a stable insulin regimen for 3 months prior to baseline, or who have a recent history of repeated hypoglycaemia or unstable glycaemic control.
* Subjects who have known hypersensitivity to HMG-CoA reductase inhibitors.
* Female subjects who consume \>14 units and male subjects who consume \>21 units of alcohol per week.
* Female subjects who are pregnant or breast feeding.
* Subjects who have not observed the designated washout periods for any of the prohibited medications.

Primary outcomes:
measure: Percent change in LDL-C from baseline to endpoint.
timeFrame: 6 weeks
Secondary outcomes:
measure: Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.
timeFrame: 6 weeks
measure: Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.
timeFrame: 6 weeks
measure: Safety: adverse events, laboratory test results, vital signs.
timeFrame: Throughout study
Other outcomes:
Locations:
Study officials:
References:
citation: Patel JV, Hughes EA. Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. Int J Clin Pract. 2006 Aug;60(8):914-21. doi: 10.1111/j.1742-1241.2006.01023.x.