Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)

NCT00653835 | Completed Phase 4

• 1 other identifier: P03435
• Study Type: interventional
• Target: 153
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypercholesterolaemia; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (3)

• Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.

  6 weeks

• 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 + Simvastatin

EXPERIMENTAL

Drug: Ezetimibe + Simvastatin

Simvastatin

ACTIVE COMPARATOR

Drug: Simvastatin

Interventions

Ezetimibe + Simvastatin DRUG

oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks

Also known as: SCH 58235, Zetia, Zocor

Ezetimibe + Simvastatin

Simvastatin DRUG

oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks

Also known as: Zocor

Simvastatin

Eligibility Criteria

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

You may qualify if:

• \>=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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Related Publications (1)

• Patel JV, Hughes EA. Efficacy, safety and LDL-C goal attainment of ezetimibe 10 mg-simvastatin 20 mg vs. placebo-simvastatin 20 mg in UK-based adults with coronary heart disease and hypercholesterolaemia. Int J Clin Pract. 2006 Aug;60(8):914-21. doi: 10.1111/j.1742-1241.2006.01023.x.

  PMID: 16893434 RESULT

MeSH Terms

Conditions

Hypercholesterolemia; Atherosclerosis

Interventions

Ezetimibe, Simvastatin Drug Combination; Ezetimibe; Simvastatin

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)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Azetidines; Azetines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

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