Back to resultsEzetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
Primary Purpose
Hypercholesterolaemia, Atherosclerosis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ezetimibe + Simvastatin
Simvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolaemia
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ezetimibe + Simvastatin
Simvastatin
Arm Description
Outcomes
Primary Outcome Measures
Percent change in LDL-C from baseline to endpoint.
Secondary Outcome Measures
Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.
Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.
Safety: adverse events, laboratory test results, vital signs.
Full Information
NCT ID
NCT00653835
First Posted
April 1, 2008
Last Updated
February 7, 2022
Sponsor
Organon and Co
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00653835
Brief Title
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
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)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2003 (Actual)
Primary Completion Date
August 1, 2004 (Actual)
Study Completion Date
August 1, 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolaemia, Atherosclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
153 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ezetimibe + Simvastatin
Arm Type
Experimental
Arm Title
Simvastatin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ezetimibe + Simvastatin
Other Intervention Name(s)
SCH 58235, Zetia, Zocor
Intervention Description
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Simvastatin
Other Intervention Name(s)
Zocor
Intervention Description
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Primary Outcome Measure Information:
Title
Percent change in LDL-C from baseline to endpoint.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Percent of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint.
Time Frame
6 weeks
Title
Percent change from baseline to endpoint in total cholesterol, HDL-C and triglycerides.
Time Frame
6 weeks
Title
Safety: adverse events, laboratory test results, vital signs.
Time Frame
Throughout study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Citations:
PubMed Identifier
16893434
Citation
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.
Results Reference
result
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)
We'll reach out to this number within 24 hrs