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

Forbes Medi-Tech150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Hypercholesterolemia

Interventions

Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (14)

Coastal Clinical Research

Mobile, Alabama, United States

Radiant Research

San Diego, California, United States

Radiant Research

Daytona Beach, Florida, United States

Outcomes

Primary Outcomes

Percent change from baseline in LDL-C at 12 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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