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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00293878

Enrollment

150

Registered

2006-02-20

Start date

2005-11-30

Completion date

Unknown

Last updated

2007-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief 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.

Interventions

DRUGDisodium Ascorbyl Phytostanol Phosphate (FM-VP4)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in LDL-C at 12 weeks	—

Secondary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026