Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia
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
1 other identifier
interventional
150
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 17, 2006
CompletedFirst Posted
Study publicly available on registry
February 20, 2006
CompletedFebruary 26, 2007
February 1, 2007
January 17, 2006
February 22, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from baseline in LDL-C at 12 weeks
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- Mild to moderate primary hypercholesterolemia
- Able to give informed consent and to comply with study procedures (including diet)
You may not qualify if:
- Homozygous familial hypercholesterolemia
- Age \<18 or \>75 years
- Pregnant women or women of child-bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Forbes Medi-Techlead
Study Sites (14)
Coastal Clinical Research
Mobile, Alabama, 36608, United States
Radiant Research
San Diego, California, 92123, United States
Radiant Research
Daytona Beach, Florida, 32114, United States
Radiant Research
Gainesville, Florida, 32605, United States
Radiant Research
Boise, Idaho, 83704, United States
Radiant Research
Chicago, Illinois, 60610, United States
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260, United States
PRA International Pharmacology Center
Lenexa, Kansas, 66219, United States
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114, United States
Radiant Research
Portland, Oregon, 97201, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464, United States
Radiant Research
Austin, Texas, 78758, United States
Research Across America
Dallas, Texas, 75234, United States
Radiant Research
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jean Warner, MD
Clinical Consultant
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 17, 2006
First Posted
February 20, 2006
Study Start
November 1, 2005
Last Updated
February 26, 2007
Record last verified: 2007-02