Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)(COMPLETED)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolaemia; Atherosclerosis
Intervention: Ezetimibe + Simvastatin (Drug); Simvastatin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Schering-Plough
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.
Clinical Details
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 design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Percent change in LDL-C from baseline to endpoint.
Secondary outcome: Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. Safety: adverse events, laboratory test results, vital signs.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: September 2003
Ending date: August 2004
Last updated: April 4, 2008
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