Ezetimibe Plus Simvastatin Versus Simvastatin in Untreated Subjects With High Cholesterol (P03435)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Collaborator:
Merck
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00653835
First received: April 1, 2008
Last updated: April 4, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolaemia Atherosclerosis |
Drug: Ezetimibe + Simvastatin Drug: Simvastatin |
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 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) |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
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 of subjects who achieve LDL-C ESC goal (ie, <3 mmol/L [115 mg/dL]) at endpoint. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- 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: | 153 |
| 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 + Simvastatin |
Drug: Ezetimibe + Simvastatin
oral tablets: ezetimibe 10 mg + simvastatin 20 mg once daily for 6 weeks
Other Names:
|
| Active Comparator: Simvastatin |
Drug: Simvastatin
oral tablets: simvastatin 20 mg + ezetimibe placebo once daily for 6 weeks
Other Name: Zocor
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| ClinicalTrials.gov Identifier: | NCT00653835 History of Changes |
| Other Study ID Numbers: | P03435 |
| Study First Received: | April 1, 2008 |
| Last Updated: | April 4, 2008 |
| 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 Simvastatin Ezetimibe Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 16, 2013