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CompletedNCT00293878Updated Feb 26, 2007

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

A Phase 2 interventional study of Disodium Ascorbyl Phytostanol Phosphate (FM-VP4) in Hypercholesterolemia, sponsored by Forbes Medi-Tech. Completed at 14 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-02-26.

Sponsored by Forbes Medi-Tech · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Hypercholesterolemia
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 150 is above the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

This is the only study on the registry with Forbes Medi-Tech as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Homozygous familial hypercholesterolemia
  • Age \<18 or >75 years
  • Pregnant women or women of child-bearing potential
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
150 participants

Interventions

  • DrugDisodium Ascorbyl Phytostanol Phosphate (FM-VP4)
06

What researchers measure

Primary outcomes

  1. Percent change from baseline in LDL-C at 12 weeks

Secondary outcomes

  1. Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks

  2. Percent change from baseline in serum lipids at 2, 4 and 8 weeks

  3. Safety

07

Study locations

14 sites
  • Coastal Clinical Research
    Mobile, Alabama 36608, United States
  • Radiant Research
    San Diego, California 92123, United States
  • Radiant Research
    Daytona Beach, Florida 32114, United States
  • Radiant Research
    Gainesville, Florida 32605, United States
  • Radiant Research
    Boise, Idaho 83704, United States
  • Radiant Research
    Chicago, Illinois 60610, United States
  • Midwest Institute for Clinical Research
    Indianapolis, Indiana 46260, United States
  • PRA International Pharmacology Center
    Lenexa, Kansas 66219, United States
  • The Center for Pharmaceutical Research
    Kansas City, Missouri 64114, United States
  • Radiant Research
    Portland, Oregon 97201, United States
  • Coastal Carolina Research Center
    Mount Pleasant, South Carolina 29464, United States
  • Radiant Research
    Austin, Texas 78758, United States
  • Research Across America
    Dallas, Texas 75234, United States
  • Radiant Research
    Dallas, Texas 75235, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00293878
Lead sponsor
Forbes Medi-Tech
First posted
Feb 20, 2006
Start date
Nov 2005
Last update
Feb 26, 2007

Study contacts

Jean Warner, MD
study director · Clinical Consultant
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2007. You cannot join it, but the record below documents what was studied.

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