NCT00762229

Brief Summary

The purpose of this study is to compare the effect on LDL cholesterol levels of converting patients who are receiving the cholesterol absorption inhibitor Zetia at a dose of 10 milligrams to 5 milligrams, when prescribed as a split 10 milligram tablet.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

June 14, 2013

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

September 29, 2008

Results QC Date

April 17, 2013

Last Update Submit

June 12, 2013

Conditions

Hypercholesterolemia

Keywords

CholesterolEzetimibe

Outcome Measures

Primary Outcomes (1)

  • LDL Cholesterol

    LDL cholesterol

    4 weeks

Secondary Outcomes (1)

  • Total Cholesterol

    4 weeks

Study Arms (2)

Ezetimibe 10 mg

ACTIVE COMPARATOR

A whole ezetimibe 10 mg tablet

Drug: Ezetimibe 10 mg

Ezetimibe 5 mg

EXPERIMENTAL

Ezetimibe 5 mg, "formulated" by splitting a 10 mg ezetimibe tablet in half

Drug: Ezetimibe 5 mg

Interventions

Ezetimibe 10 mgDRUG

Ezetimibe 10 mg daily for 4 weeks

Also known as: Zetia
Ezetimibe 10 mg
Ezetimibe 5 mgDRUG

Ezetimibe 5 mg daily for 4 weeks, "formulated" as a 10 mg tablet split in half

Also known as: Zetia
Ezetimibe 5 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects receiving ezetimibe 10 mg
  • Subjects who have demonstrated compliance with ezetimibe as evidenced by the following Proportions of Days Covered patterns (which represent a PDC of more than 75%):
  • day prescriptions: Filled a ezetimibe prescription within the previous 4 months
  • day prescriptions: Filled a ezetimibe prescription within the previous 2.5 months
  • day prescriptions: Filled a ezetimibe prescription within the previous 1.5 months
  • Patients willing and able to provide signed informed consent

You may not qualify if:

  • Patients not receiving ezetimibe
  • Patients receiving ezetimibe 5 milligrams
  • Patients with a history of being titrated from ezetimibe 5 to 10 mg. Stroke,TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within the 3 months
  • Cancer undergoing active treatment
  • Participation in any clinical study within the last 30 days
  • Drug addiction or alcohol abuse within the past 6 months
  • Patients unwilling or unable to provide informed consent
  • Patients with poor compliance
  • Women of childbearing potential

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bronx VA Medical Center

The Bronx, New York, 10468, United States

Location

Related Publications (1)

  • Baruch L, Agarwal S, Gupta B, Haynos A, Eng C. Effect on serum lipid levels of switching dose of ezetimibe from 10 to 5 mg. Am J Cardiol. 2009 Jun 1;103(11):1568-71. doi: 10.1016/j.amjcard.2009.01.365. Epub 2009 Apr 22.

    PMID: 19463517RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

Ezetimibe

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AzetidinesAzetinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Lawrence Baruch
Organization
Bronx VA Medical Center
lawrence.baruch@va.gov
718-584-9000

Study Officials

  • Lawrence Baruch, MD

    Bronx VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff physician

Study Record Dates

First Submitted

September 29, 2008

First Posted

September 30, 2008

Study Start

July 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

June 14, 2013

Results First Posted

June 14, 2013

Record last verified: 2013-06

Locations

US(1)