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NCT00293878 Clinical Trial

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

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00293878
Other study ID # CL2005-001
Secondary ID
Status Completed
Phase Phase 2
First received January 17, 2006
Last updated February 22, 2007
Start date November 2005

Study information
Verified date February 2007
Source Forbes Medi-Tech
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date
Est. primary completion date
Accepts healthy volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)

Locations
Country Name City State
United States Radiant Research Austin Texas
United States Radiant Research Boise Idaho
United States Radiant Research Chicago Illinois
United States Radiant Research Dallas Texas
United States Research Across America Dallas Texas
United States Radiant Research Daytona Beach Florida
United States Radiant Research Gainesville Florida
United States Midwest Institute for Clinical Research Indianapolis Indiana
United States The Center for Pharmaceutical Research Kansas City Missouri
United States PRA International Pharmacology Center Lenexa Kansas
United States Coastal Clinical Research Mobile Alabama
United States Coastal Carolina Research Center Mount Pleasant South Carolina
United States Radiant Research Portland Oregon
United States Radiant Research San Diego California

Sponsors (1)
Lead Sponsor Collaborator
Forbes Medi-Tech

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percent change from baseline in LDL-C at 12 weeks
Secondary Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks
Secondary Percent change from baseline in serum lipids at 2, 4 and 8 weeks
Secondary Safety
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