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Completed

NCT Number: NCT00293878

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Coastal Clinical Research, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)

Drug

Primary outcomes

  1. Percent change from baseline in LDL-C at 12 weeks

Secondary outcomes

  1. Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks

  2. Percent change from baseline in serum lipids at 2, 4 and 8 weeks

  3. Safety

Sponsors and collaborators

Lead sponsor

Forbes Medi-Tech

Industry

Registry information

Official study 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

Important dates

Study start
2005
First posted
Feb 20, 2006
Registry last updated
Feb 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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