Familial HypercholesterolemiaPhase 2NCT00079859
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
A Phase 2 study testing Implitapide in people with Familial Hypercholesterolemia, run by Medical Research Laboratories International at 6 sites in 3 countries.
Trial summary
The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Familial Hypercholesterolemia
- What is being tested?
- Implitapide
- How many people
- 120 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Oct 2003to Apr 2005
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In order to participate in this study, patients must meet all of the following inclusion criteria:
- be between 18 and 70 years old with a diagnosis of HeFH;
- be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
- have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
- be male or nonpregnant, nonlactating female;
- give informed consent; and
- meet body weight requirements.
Who cannot join
- In order to participate in this study, patients must not meet any of the following exclusion criteria:
- recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
- uncontrolled hypothyroidism or other uncontrolled endocrine disease;
- known, clinically significant eye abnormalities (e.g., cataracts);
- appropriate serum creatinine phosphokinase levels;
- history of liver disease or liver enzyme levels above appropriate levels;
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- alkaline phosphatase above appropriate levels;
- serum creatinine above appropriate levels;
- liver cirrhosis and severe liver steatosis;
- clinically significant infection, malignancy, or psychosis;
- use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
- participation in any other investigational study, including device or observational studies, within 30 days;
- lactating or have a positive serum pregnancy test;
- current drug or alcohol abuse; or
- unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Netherlands4 sites
Andromed Leiden
Leiden
Andromed Rotterdam
Rotterdam
Andromed Oost
Velp
Andromed Zoetermeer
Zoetermeer
United States1 site
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, 45229
About this study
Official title: Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).
- Conditions
- Familial Hypercholesterolemia
- Being tested
- Implitapide
- Keywords
- Heterozygous Familial Hypercholesterolemia (HeFH)
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImplitapideDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2004 (estimated)
- Study startOct 2003
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial 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
- Single group
- Masking
- Double blind
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- Medical Research Laboratories International
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00079859
- Sponsor's protocol ID
- MRL 2002-002
- Status last verified
- Apr 2005
- First submitted
- 17 Mar 2004
- Last updated
- 24 Jun 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
- ClinicalTrials.gov ID
- NCT00079859
- Acronym / sponsor ID
- MRL 2002-002
- Conditions
- Familial Hypercholesterolemia
- Keywords
- Heterozygous Familial Hypercholesterolemia (HeFH)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 120 participants
- Lead sponsor
- Medical Research Laboratories InternationalIndustry (pharma, biotech, devices)
- Study start
- Oct 2003
- Study completion
- Apr 2005
- First posted
- 18 Mar 2004 (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 determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- In order to participate in this study, patients must meet all of the following inclusion criteria:
- be between 18 and 70 years old with a diagnosis of HeFH;
- be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
- have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
- be male or nonpregnant, nonlactating female;
Key exclusion criteria (15 listed)
- In order to participate in this study, patients must not meet any of the following exclusion criteria:
- recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
- uncontrolled hypothyroidism or other uncontrolled endocrine disease;
- known, clinically significant eye abnormalities (e.g., cataracts);
- appropriate serum creatinine phosphokinase levels;
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 |
|---|---|---|
| Implitapide | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
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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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Implitapide in people with Familial Hypercholesterolemia, run by Medical Research Laboratories International at 6 sites in 3 countries.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands, United States, Norway. 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 was stopped early. Results are not available in the source record.
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.
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 24 Jun 2005.