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

This study has been completed.
Sponsor:
Information provided by:
Forbes Medi-Tech
ClinicalTrials.gov Identifier:
NCT00293878
First received: January 17, 2006
Last updated: February 22, 2007
Last verified: February 2007
  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-Blind
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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Radiant Research
Dallas, Texas, United States, 75235
Research Across America
Dallas, Texas, United States, 75234
Sponsors and Collaborators
Forbes Medi-Tech
Investigators
Study Director: Jean Warner, MD Clinical Consultant
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00293878     History of Changes
Other Study ID Numbers: CL2005-001
Study First Received: January 17, 2006
Last Updated: February 22, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014