Ezetimibe Reverse Cholesterol Transport (RCT) Pilot Study

This study has been completed.

Study NCT00701727 Information provided by Radiant Research

First Received on June 17, 2008. Last Updated on March 14, 2011 History of Changes

Results First Received: January 10, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypercholesterolemia
Interventions:	Drug: ezetimibe Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants recruited at a research clinic, Chicago, IL, from June 2008 to October 2008

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
61 subjects screened, 30 subjects excluded(8 failed inclusion criteria, 9 failed exclusion criteria, 3 had unsuitable veins, 5 failed a drug screen, 1 was lost-to-follow-up, 4 were excluded when enrollment was complete), 31 subjects randomized.

Reporting Groups

	Description
Ezetimibe First, Placebo Second	Ezetimibe first for 7 weeks, followed by placebo for 7 weeks
Placebo First, Ezetimibe Second	Placebo first for 7 weeks,followed by ezetimibe for 7 weeks

Participant Flow for 2 periods

Period 1: First Treatment Period

	Ezetimibe First, Placebo Second	Placebo First, Ezetimibe Second
STARTED	16	15
COMPLETED	15	13
NOT COMPLETED	1	2
Adverse Event	0	0
Withdrawal by Subject	1	0
sponsor decision	0	1
Lost to Follow-up	0	1

Period 2: Second Treatment Period

	Ezetimibe First, Placebo Second	Placebo First, Ezetimibe Second
STARTED	15	13
COMPLETED	13	13
NOT COMPLETED	2	0
Withdrawal by Subject	2	0

Baseline Characteristics

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Reporting Groups

	Description
Entire Study Population	Includes groups randomized to receive ezetimibe first and placebo first

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	31
Age [units: participants]
<=18 years	0
Between 18 and 65 years	27
>=65 years	4
Gender [units: participants]
Female	11
Male	20
Region of Enrollment [units: participants]
United States	31

Outcome Measures

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1. Primary:

Fecal Excretion of Plasma-derived Cholesterol [ Time Frame: 7 weeks ]

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2. Secondary:

Change From Baseline in Total Cholesterol, From Fasting Plasma Samples [ Time Frame: 7 weeks ]

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3. Secondary:

de Novo Cholesterol Synthesis (DNC) [ Time Frame: 7 weeks ]

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4. Secondary:

Cholesterol Efflux Rate (Ra Cholesterol) [ Time Frame: 7 weeks ]

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5. Secondary:

Triglycerides (TG) [ Time Frame: 7 weeks ]

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6. Secondary:

Low-density Lipoprotein (LDL); [ Time Frame: 7 weeks ]

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7. Secondary:

High-density Lipoprotein (HDL) [ Time Frame: 7 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Michael H Davidson, MD FACC
Organization: Radiant Research
phone: 312-494-2220
e-mail: michaeldavidson@radiantresearch.com

No publications provided

Responsible Party:	Michael H. Davidson, MD, FACC, Radiant Research
ClinicalTrials.gov Identifier:	NCT00701727 History of Changes
Other Study ID Numbers:	Ezetimibe RCT-001
Study First Received:	June 17, 2008
Results First Received:	January 10, 2011
Last Updated:	March 14, 2011
Health Authority:	United States: Food and Drug Administration