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Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)
This study has been completed.
First Received: April 1, 2008   Last Updated: April 4, 2008   History of Changes
Sponsors and Collaborators: Schering-Plough
Merck
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00653796
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Atherosclerosis
Drug: Ezetimibe + Atorvastatin
Drug: Atorvastatin
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 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

Resource links provided by NLM:


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 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: 148
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 + Atorvastatin: Experimental Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
Atorvastatin: Active Comparator Drug: Atorvastatin
oral tablets: atorvastatin 10 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:

  • 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.

Exclusion Criteria:

  • 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
  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: P03434
Study First Received: April 1, 2008
Last Updated: April 4, 2008
ClinicalTrials.gov Identifier: NCT00653796     History of Changes
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:
Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Heart Diseases
Hyperlipidemias
Metabolic Diseases
Antilipemic Agents
Vascular Diseases
Ezetimibe
Anticholesteremic Agents
Arteriosclerosis
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Coronary Disease
Hypercholesterolemia
Metabolic Disorder
Atorvastatin
Coronary Artery Disease
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Antimetabolites
Atherosclerosis
Arterial Occlusive Diseases
Hyperlipidemias
Metabolic Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Vascular Diseases
Enzyme Inhibitors
Ezetimibe
Arteriosclerosis
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Cardiovascular Diseases
Hypercholesterolemia
Dyslipidemias
Atorvastatin
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009