Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
First received: April 1, 2008
Last updated: April 28, 2014
Last verified: April 2014
This study was designed to assess whether co-administration of ezetimibe 10 mg with atorvastatin 10 mg in treatment naïve subjects would be more effective than treatment with atorvastatin 10 mg alone for reducing LDL-concentrations.
Drug: Ezetimibe + Atorvastatin
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||SCH 58235: A Multicentre, Randomised, Parallel Group, Placebo-Controlled Study Comparing the Efficacy, Safety, And Tolerability of the Daily Co-Administration of Ezetimibe 10 mg With Atorvastatin 10 mg vs. Ezetimibe Placebo With Atorvastatin 10 mg in Untreated Subjects With Primary Hypercholesterolaemia and Coronary Heart Disease
Primary Outcome Measures:
- Percent change in LDL-C from baseline to endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Safety: adverse events, laboratory test results, vital signs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2004 (Final data collection date for primary outcome measure)
Experimental: Ezetimibe + Atorvastatin
Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
Active Comparator: Atorvastatin
oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
Other Name: Lipitor
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Male and non-pregnant female subjects, who demonstrated willingness to participate and comply with procedures by signing informed consent, and who were >=18 years and <=75 years of age, were eligible to participate if they had: a baseline LDL-C concentration >=3.3 mmol/L (130 mg/dL) to <=4.9 mmol/L (190 mg/dL); a baseline triglyceride concentration of <3.99 mmol/L (350 mg/dL); a documented history of coronary heart disease (CHD); a stable weight history for 4 weeks prior to baseline; completion of the designated washout periods for all prohibited medications; and did not fulfill any of the exclusion criteria for the study.
- Body Mass Index of >=30 kg/m^2 at baseline (increased to 35 kg/m^2 in protocol amendment 1
- Liver transaminase (ALT, AST) >1.5 times the upper limit of normal and with no active liver disease at baseline
- Evidence of current myopathy (excluding subjects with CK >1.5 times above the upper limit of normal at baseline
- Clinical lab tests (CBC, blood chemistries, urinalysis) results outside the normal range or unacceptable to the investigator at baseline
- Type II diabetes mellitus that was poorly controlled (HbA1c>9%), newly diagnosed, or changed their anti-diabetic therapy within 3 months of baseline
- Type I diabetes mellitus and not on a stable insulin regimen for 3 months prior to baseline or who had a recent history of repeated hypoglycaemia or unstable glycaemic control
- Known hypersensitivity to HMG-CoA reductase inhibitors
- Alcohol consumption >14 units (women)/21 units (men) (unit = 0.5 pint of beer or wine, or single measure of spirits)
- Pregnancy, lactation, or any condition or situation which, in the opinion of the investigator, posed a risk to the subject or interfered with participation in this study.
- Any of the following medical conditions: HIV positive; congestive heart failure defined by NYHA as Class III or IV; uncontrolled cardiac arrhythmia; MI, acute coronary insufficiency, CABG, or angioplasty within 3 months of baseline; unstable or severe peripheral artery disease within 3 months of baseline; newly diagnosed or unstable angina pectoris at baseline; uncontrolled hypertension with systolic blood pressure >100 mm Hg at baseline; uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins; impaired renal function or nephritic syndrome at baseline; disorders of the hematological, gastrointestinal, or central nervous systems; diseases other than hyperlipidaemia or coronary heart disease that would have interfered with study evaluations; and cancer.
- Drug abuse or emotional or intellectual problems;
- Use of certain drugs, food, or other agents known to alter cholesterol levels or to cause pharmacokinetic interactions with either ezetimibe or atorvastatin
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||Merck Sharp & Dohme Corp.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 1, 2008
||April 28, 2014
||United Kingdom: Medicines and Healthcare Products Regulatory Agency
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 23, 2014
Arterial Occlusive Diseases
Lipid Metabolism Disorders
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action