Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
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 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.
Drug: Ezetimibe + Simvastatin
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||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)
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 of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- 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 + Simvastatin
Drug: Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
Active Comparator: Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Other Name: Zocor
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- >=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.
- 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.
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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 September 18, 2014
Lipid Metabolism Disorders
Arterial Occlusive Diseases
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors