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

This study has been completed.

First Received: January 17, 2006 Last Updated: February 22, 2007 History of Changes

Sponsored by:	Forbes Medi-Tech
Information provided by:	Forbes Medi-Tech
ClinicalTrials.gov Identifier:	NCT00293878

Purpose

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.

Condition	Intervention	Phase
Hypercholesterolemia	Drug: Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)	Phase II

Genetics Home Reference related topics: hypercholesterolemia

MedlinePlus related topics: Cholesterol

Drug Information available for: Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Effects on Lipids of 12 Weeks of 2 Doses of FM-VP4 in Subjects With Primary Hypercholesterolemia

Further study details as provided by Forbes Medi-Tech:

Primary Outcome Measures:

Percent change from baseline in LDL-C at 12 weeks

Secondary Outcome Measures:

Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks
Percent change from baseline in serum lipids at 2, 4 and 8 weeks
Safety

Estimated Enrollment:	150
Study Start Date:	November 2005

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00293878

Locations

United States, Alabama
Coastal Clinical Research
Mobile, Alabama, United States, 36608
United States, California
Radiant Research
San Diego, California, United States, 92123
United States, Florida
Radiant Research
Gainesville, Florida, United States, 32605
Radiant Research
Daytona Beach, Florida, United States, 32114
United States, Idaho
Radiant Research
Boise, Idaho, United States, 83704
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Indiana
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
PRA International Pharmacology Center
Lenexa, Kansas, United States, 66219
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97201
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Radiant Research
Dallas, Texas, United States, 75235
Research Across America
Dallas, Texas, United States, 75234
Radiant Research
Austin, Texas, United States, 78758

Sponsors and Collaborators

Forbes Medi-Tech

Investigators

Study Director:

Jean Warner, MD

Clinical Consultant

More Information

No publications provided

Study ID Numbers:	CL2005-001
Study First Received:	January 17, 2006
Last Updated:	February 22, 2007
ClinicalTrials.gov Identifier:	NCT00293878 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Metabolic Diseases
Hyperlipidemias
Metabolic Disorder

Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Metabolic Diseases
Hyperlipidemias
Hypercholesterolemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009