HypercholesterolemiaPhase 2NCT00293878
Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia
A Phase 2 study testing Disodium Ascorbyl Phytostanol Phosphate (FM-VP4) in people with Hypercholesterolemia, run by Forbes Medi-Tech at 14 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)
- How many people
- 150 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2005to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- Mild to moderate primary hypercholesterolemia
- Able to give informed consent and to comply with study procedures (including diet)
Who cannot join
- Homozygous familial hypercholesterolemia
- Age <18 or >75 years
- Pregnant women or women of child-bearing potential
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Radiant Research
Austin, Texas, 78758
Radiant Research
Boise, Idaho, 83704
Radiant Research
Chicago, Illinois, 60610
Research Across America
Dallas, Texas, 75234
Radiant Research
Dallas, Texas, 75235
Radiant Research
Daytona Beach, Florida, 32114
Radiant Research
Gainesville, Florida, 32605
Midwest Institute for Clinical Research
Indianapolis, Indiana, 46260
The Center for Pharmaceutical Research
Kansas City, Missouri, 64114
PRA International Pharmacology Center
Lenexa, Kansas, 66219
Coastal Clinical Research
Mobile, Alabama, 36608
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, 29464
Radiant Research
Portland, Oregon, 97201
Radiant Research
San Diego, California, 92123
About this study
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
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.
- Conditions
- Hypercholesterolemia
- Being tested
- Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Disodium Ascorbyl Phytostanol Phosphate (FM-VP4)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2006 (estimated)
- Study startNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- Forbes Medi-Tech
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jean Warner, MD, Study director, Clinical Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00293878
- Sponsor's protocol ID
- CL2005-001
- Status last verified
- Feb 2007
- First submitted
- 17 Jan 2006
- Last updated
- 26 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00293878
- Acronym / sponsor ID
- CL2005-001
- Conditions
- Hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- Forbes Medi-TechIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- First posted
- 20 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild to moderate primary hypercholesterolemia
- Able to give informed consent and to comply with study procedures (including diet)
Key exclusion criteria (3 listed)
- Homozygous familial hypercholesterolemia
- Age <18 or >75 years
- Pregnant women or women of child-bearing potential
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Disodium Ascorbyl Phytostanol Phosphate (FM-VP4) | Drug | – |
Primary outcome
Percent change from baseline in LDL-C at 12 weeks
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2007.
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Warner, MD study director
Clinical Consultant
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Disodium Ascorbyl Phytostanol Phosphate (FM-VP4) in people with Hypercholesterolemia, run by Forbes Medi-Tech at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in LDL-C at 12 weeks. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2007.