Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)(COMPLETED) - Full Text View

Sponsor:	Schering-Plough
Collaborator:	Merck
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00653835

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolaemia Atherosclerosis	Drug: Ezetimibe + Simvastatin Drug: Simvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Simvastatin Ezetimibe

U.S. FDA Resources

Further study details as provided by Schering-Plough:

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 ]

Enrollment:	153
Study Start Date:	September 2003
Study Completion Date:	August 2004
Primary Completion Date:	August 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Ezetimibe + Simvastatin: Experimental	Drug: Ezetimibe + Simvastatin oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
Simvastatin: Active Comparator	Drug: Simvastatin oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers:	P03435
Study First Received:	April 1, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00653835 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:

Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Simvastatin
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors

Ezetimibe
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on November 25, 2009