Ezetimibe Plus Atorvastatin Versus Atorvastatin in Untreated Subjects With High Cholesterol (P03434)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00653796
First received: April 1, 2008
Last updated: April 28, 2014
Last verified: April 2014
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Merck Sharp & Dohme Corp.:

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
Experimental: Ezetimibe + Atorvastatin Drug: Ezetimibe + Atorvastatin
oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks
Other Names:
  • SCH 58235
  • Zetia
  • Lipitor
Active Comparator: Atorvastatin Drug: Atorvastatin
oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks
Other Name: Lipitor

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00653796     History of Changes
Other Study ID Numbers: P03434
Study First Received: April 1, 2008
Last Updated: April 28, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 29, 2014