Coadministration of Ezetimibe and Atorvastatin in Patients With Primary Hypercholesterolemia (P05456)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00654095
First received: April 1, 2008
Last updated: July 1, 2014
Last verified: July 2014
  Purpose

Evaluate the safety of the long-term (1 year) coadministration of ezetimibe and atorvastatin in participants 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: atorvastatin
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 Atorvastatin 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 Merck Sharp & Dohme Corp.:

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 considered treatment-related was considered an adverse reaction.



Enrollment: 146
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 + Atorvastatin
Ezetimibe 10 mg + Atorvastatin 20 mg
Drug: Ezetimibe
Ezetimibe 10 mg once daily
Other Name: SCH 58235
Drug: atorvastatin
atorvastatin 20 mg once daily

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants with hypercholesterolemia who satisfy the following criteria:

    • Participants who have used any of the following 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (hereinafter referred to as "statins") for 4 weeks or longer before the start of the observation period and whose low density lipoprotein (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:

  • Participants for whom any of the following is applicable:

    • Participants whose fasted triglyceride level measured at the start of the observation period or the treatment period exceeds 500 mg/dL
    • Participants with homozygous familial hypercholesterolemia
    • Participants with creatine phosphokinase (CPK) > 2x upper limit of normal (ULN) measured at the start of the observation period or the treatment period.
    • Participants with serious hepatic disorder, or participants with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2x ULN measured at the start of the observation period or the treatment period.
    • Participants with a history of hypersensitivity to any ingredient of ezetimibe tablets or atorvastatin tablets
    • Pregnant, nursing women, women who may be pregnant, or participants wishing to be pregnant during the study.
    • Participants 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 participant 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.)
    • Participants who are using cyclosporine from after the start of the observation period
    • Participants with a history of ezetimibe use
    • Participants with hyperlipidemia associated with the following diseases:

      • Hypothyroidism
      • Obstructive gall bladder or biliary disease
      • Chronic renal failure
      • Pancreatitis
    • Participants with hyperlipidemia associated with concomitant use of drugs having adverse effect on serum lipids, etc
    • Participants who have received an investigational drug within 4 weeks of the start of the observation period
    • Other participants deemed not appropriate for study entry by the investigator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00654095     History of Changes
Other Study ID Numbers: P05456
Study First Received: April 1, 2008
Results First Received: May 27, 2010
Last Updated: July 1, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Ezetimibe
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014