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

NCT00653796 | Completed Phase 4

• 1 other identifier: P03434
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypercholesterolemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Percent change in LDL-C from baseline to endpoint.

  6 weeks

Secondary Outcomes (2)

• Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.

  6 weeks

• Safety: adverse events, laboratory test results, vital signs.

  Throughout study

Study Arms (2)

Ezetimibe + Atorvastatin

EXPERIMENTAL

Drug: Ezetimibe + Atorvastatin

Atorvastatin

ACTIVE COMPARATOR

Drug: Atorvastatin

Interventions

Ezetimibe + Atorvastatin DRUG

oral tablets: ezetimibe 10 mg + atorvastatin 10 mg once daily for 6 weeks

Also known as: SCH 58235, Zetia, Lipitor

Ezetimibe + Atorvastatin

Atorvastatin DRUG

oral tablets: atorvastatin 10 mg + ezetimibe placebo once daily for 6 weeks

Also known as: Lipitor

Atorvastatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Organon and Co: lead
• Merck Sharp & Dohme LLC: collaborator

Related Publications (1)

• Blagden MD, Chipperfield R. Efficacy and safety of ezetimibe co-administered with atorvastatin in untreated patients with primary hypercholesterolaemia and coronary heart disease. Curr Med Res Opin. 2007 Apr;23(4):767-75. doi: 10.1185/030079907x182059.

  PMID: 17407633 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe; Atorvastatin

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrroles; Azoles; Heptanoic Acids; Fatty Acids; Lipids

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 7, 2008
• Study Start: September 1, 2003
• Primary Completion: August 1, 2004
• Study Completion: August 1, 2004
• Last Updated: August 15, 2024

Record last verified: 2022-02