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

Atherosclerosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00653835
• Other study ID #: P03435
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2003
• Est. completion date: August 1, 2004

Study information

• Verified date: February 2022
• Source: Organon and Co
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: August 1, 2004
• Est. primary completion date: August 1, 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolaemia
• Hypercholesterolemia

Intervention

Drug:
• Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
• Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Organon and Co	Merck Sharp & Dohme Corp.

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in LDL-C from baseline to endpoint.		6 weeks
Secondary	Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.		6 weeks
Secondary	Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.		6 weeks
Secondary	Safety: adverse events, laboratory test results, vital signs.		Throughout study