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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)
Sponsored by
Forbes Medi-Tech
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

Sites / Locations

  • Coastal Clinical Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Radiant Research
  • Midwest Institute for Clinical Research
  • PRA International Pharmacology Center
  • The Center for Pharmaceutical Research
  • Radiant Research
  • Coastal Carolina Research Center
  • Radiant Research
  • Research Across America
  • Radiant Research

Outcomes

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

Full Information

First Posted
January 17, 2006
Last Updated
February 22, 2007
Sponsor
Forbes Medi-Tech
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1. Study Identification

Unique Protocol Identification Number
NCT00293878
Brief Title
Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Forbes Medi-Tech

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)
Primary Outcome Measure Information:
Title
Percent change from baseline in LDL-C at 12 weeks
Secondary Outcome Measure Information:
Title
Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks
Title
Percent change from baseline in serum lipids at 2, 4 and 8 weeks
Title
Safety

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Warner, MD
Organizational Affiliation
Clinical Consultant
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Radiant Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Radiant Research
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Radiant Research
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Radiant Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83704
Country
United States
Facility Name
Radiant Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
Midwest Institute for Clinical Research
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
PRA International Pharmacology Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Radiant Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Coastal Carolina Research Center
City
Mount Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
Facility Name
Radiant Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
Research Across America
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Radiant Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

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

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