Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercholesterolemia
Intervention: Ezetimibe (Drug); atorvastatin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Summary
Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin
in patients with hypercholesterolemia who have not reached LDL-cholesterol target with
HMG-CoA reductase inhibitors.
Clinical Details
Official title: Open-Label, Long-Term Study of Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia Who Have Not Reached LDL-Cholesterol Target With HMG-CoA Reductase Inhibitors
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Adverse events and adverse reactions
Secondary outcome: Laboratory test results and vital signs% change in LDL-cholesterol from before the start of treatment to the end of treatment Proportion of patients showing an LDL-cholesterol value reaching the lipid management target % change in serum lipids, serum lipoproteins, and hs-CRP
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
- Age: 20 years of age or older (at the time of obtaining informed consent)
- Sex: both males and females
- Inpatient/outpatient: Out-patient
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 CPK > 2x ULN measured at the start of the observation period or the
treatment period.
- Patients with serious hepatic disorder, or patients with ALT or 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 atorvastatin 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 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
Locations and Contacts
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 1, Okinawa 901-2132, Japan; Recruiting
Additional Information
Starting date: December 2007
Ending date: May 2009
Last updated: April 1, 2008
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