Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia (P05457)(COMPLETED)
This study has been completed.
Sponsor:
Schering-Plough
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00653523
First received: April 1, 2008
Last updated: August 12, 2010
Last verified: August 2010
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Purpose
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and simvastatin in patients with hypercholesterolemia who have not reached low density lipoprotein (LDL)-cholesterol target with 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Drug: Ezetimibe Drug: Simvastatin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-label, Long-term Study of Coadministration of Ezetimibe and Simvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-cholesterol Target With HMG-CoA Reductase Inhibitors |
Resource links provided by NLM:
Further study details as provided by Schering-Plough:
Primary Outcome Measures:
- Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ] [ Designated as safety issue: Yes ]
An adverse event is any unfavorable medical event occurring in a subject to whom an investigational product is administered, and a causal relationship between the administered investigational product and an adverse event is not always clarified.
That is, an adverse event is any unfavorable or unintended sign (including an abnormal change in laboratory test values), symptom, or disease, and a causal relationship to the relevant investigational product is not considered.
Any adverse event that was treatment-related was considered an adverse reaction.
| Enrollment: | 151 |
| Study Start Date: | December 2007 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Ezetimibe + Simvastatin
Ezetimibe 10 mg + Simvastatin 20 mg
|
Drug: Ezetimibe
Ezetimibe 10 mg once daily
Other Name: SCH 58235
Drug: Simvastatin
Simvastatin 20 mg daily
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients with hypercholesterolemia who satisfy the following criteria:
- Patients who have used any of the following HMG-CoA reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose LDL-cholesterol level during the treatment had not reached lipid management target indicated below
- Age: 20 years of age or older (at the time of obtaining informed consent)
- Sex: both males and females
- Inpatient/outpatient: Out-patients
Exclusion Criteria:
Patients for whom any of the following is applicable:
- Patients whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
- Patients with homozygous familial hypercholesterolemia
- Patients with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
- Patients with serious hepatic disorder, or patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period.
- Patients with a history of hypersensitivity to any ingredient of ezetimibe tablets or simvastatin tablets
- Pregnant, nursing women, women who may be pregnant, or patients wishing to be pregnant during the study.
- Patients who have discontinued use of serum lipid lowering agents for less than 4 weeks at the start of the treatment period (8 weeks in the case of probucol). (However, if the patient had taken a serum lipid lowering agent before the test conducted at the start of the observation period, a period of discontinuation of 27 days, or 55 days in the case of probucol, is allowed.)
- Patients who are using cyclosporine from after the start of the observation period
- Patients who are using any of the following drug from after the start of the observation period: itraconazole, miconazole, atazanavir, saquinavir mesilate
- Patients with a history of ezetimibe use
Patients with hyperlipidemia associated with the following diseases:
- Hypothyroidism
- Obstructive gall bladder or biliary disease
- Chronic renal failure
- Pancreatitis
- Patients with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
- Patients who have received an investigational drug within 4 weeks of the start of the observation period
- Other patients deemed not appropriate for study entry by the investigator
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: | NCT00653523 History of Changes |
| Other Study ID Numbers: | P05457 |
| Study First Received: | April 1, 2008 |
| Results First Received: | May 27, 2010 |
| Last Updated: | August 12, 2010 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Simvastatin Ezetimibe Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013