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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00293878
First Posted: February 20, 2006
Last Update Posted: February 26, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forbes Medi-Tech
  Purpose
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.

Condition Intervention Phase
Hypercholesterolemia Drug: Disodium Ascorbyl Phytostanol Phosphate (FM-VP4) Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Forbes Medi-Tech:

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

Estimated Enrollment: 150
Study Start Date: November 2005
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00293878


Locations
United States, Alabama
Coastal Clinical Research
Mobile, Alabama, United States, 36608
United States, California
Radiant Research
San Diego, California, United States, 92123
United States, Florida
Radiant Research
Daytona Beach, Florida, United States, 32114
Radiant Research
Gainesville, Florida, United States, 32605
United States, Idaho
Radiant Research
Boise, Idaho, United States, 83704
United States, Illinois
Radiant Research
Chicago, Illinois, United States, 60610
United States, Indiana
Midwest Institute for Clinical Research
Indianapolis, Indiana, United States, 46260
United States, Kansas
PRA International Pharmacology Center
Lenexa, Kansas, United States, 66219
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, Oregon
Radiant Research
Portland, Oregon, United States, 97201
United States, South Carolina
Coastal Carolina Research Center
Mount Pleasant, South Carolina, United States, 29464
United States, Texas
Radiant Research
Austin, Texas, United States, 78758
Research Across America
Dallas, Texas, United States, 75234
Radiant Research
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Forbes Medi-Tech
Investigators
Study Director: Jean Warner, MD Clinical Consultant
  More Information

ClinicalTrials.gov Identifier: NCT00293878     History of Changes
Other Study ID Numbers: CL2005-001
First Submitted: January 17, 2006
First Posted: February 20, 2006
Last Update Posted: February 26, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases