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

• ClinicalTrials.gov Identifier: NCT00654095
• Recruitment Status: Completed
• First Posted: April 7, 2008
• Results First Posted: October 5, 2010
• Last Update Posted: February 16, 2022
• Sponsor: Organon and Co
• Information provided by (Responsible Party): Organon and Co

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: Ezetimibe; Drug: atorvastatin	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 146 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: December 1, 2007
• Actual Primary Completion Date: June 1, 2009
• Actual Study Completion Date: June 1, 2009

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Number of Participants With Adverse Events and Adverse Reactions [ Time Frame: Throughout 1 year of study ]

   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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

No Contacts or Locations Provided

More Information

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT00654095
• Other Study ID Numbers: P05456
• First Posted: April 7, 2008
• Results First Posted: October 5, 2010
• Last Update Posted: February 16, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Atorvastatin; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors