Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia

NCT ID: NCT00293878

Last Updated: 2007-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4 administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.

Detailed Description

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Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mild to moderate primary hypercholesterolemia
* Able to give informed consent and to comply with study procedures (including diet)

Exclusion Criteria

* Homozygous familial hypercholesterolemia
* Age \<18 or \>75 years
* Pregnant women or women of child-bearing potential
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forbes Medi-Tech

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jean Warner, MD

Role: STUDY_DIRECTOR

Clinical Consultant

Locations

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Coastal Clinical Research

Mobile, Alabama, United States

Site Status

Radiant Research

San Diego, California, United States

Site Status

Radiant Research

Daytona Beach, Florida, United States

Site Status

Radiant Research

Gainesville, Florida, United States

Site Status

Radiant Research

Boise, Idaho, United States

Site Status

Radiant Research

Chicago, Illinois, United States

Site Status

Midwest Institute for Clinical Research

Indianapolis, Indiana, United States

Site Status

PRA International Pharmacology Center

Lenexa, Kansas, United States

Site Status

The Center for Pharmaceutical Research

Kansas City, Missouri, United States

Site Status

Radiant Research

Portland, Oregon, United States

Site Status

Coastal Carolina Research Center

Mt. Pleasant, South Carolina, United States

Site Status

Radiant Research

Austin, Texas, United States

Site Status

Research Across America

Dallas, Texas, United States

Site Status

Radiant Research

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CL2005-001

Identifier Type: -

Identifier Source: org_study_id

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