- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00079859
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
June 23, 2005 updated by: Medical Research Laboratories International
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).
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
120
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Leiden, Netherlands
- Andromed Leiden
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Rotterdam, Netherlands
- Andromed Rotterdam
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Velp, Netherlands
- Andromed Oost
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Zoetermeer, Netherlands
- Andromed Zoetermeer
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Oslo, Norway
- Lipidklinikken - Rikshospitalet
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Ohio
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Cincinnati, Ohio, United States, 45229
- Metabolic and Atherosclerosis Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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.
Exclusion Criteria:
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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2003
Study Completion
April 1, 2005
Study Registration Dates
First Submitted
March 17, 2004
First Submitted That Met QC Criteria
March 17, 2004
First Posted (Estimate)
March 18, 2004
Study Record Updates
Last Update Posted (Estimate)
June 24, 2005
Last Update Submitted That Met QC Criteria
June 23, 2005
Last Verified
April 1, 2005
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRL 2002-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Familial Hypercholesterolemia
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National Medical Research Center for Therapy and...Moscow State University of Medicine and DentistryRecruitingMedication Adherence | Adherence, Medication | Treatment Adherence | Familial Hypercholesterolemia | Motivational Interviewing | Adherence, Patient | Treatment Adherence and Compliance | Patient Compliance | Adherence | Hypercholesterolemia, Familial | Patient Adherence | Hypercholesterolemia, Autosomal Dominant and other conditionsRussian Federation
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Regeneron PharmaceuticalsSanofiTerminatedHeterozygous Familial Hypercholesterolemia | Non-familial HypercholesterolemiaUnited States, Bulgaria, Estonia, Russian Federation, South Africa, Ukraine
-
Merck Sharp & Dohme LLCTerminatedHypercholesterolemia, Familial | Heterozygous Familial Hypercholesterolemia
-
Institut Investigacio Sanitaria Pere VirgiliRecruitingFamilial Hypercholesterolemia | Familial Hypercholesterolemia - Homozygous | Familial Hypercholesterolemia - HeterozygousSpain
-
Novartis PharmaceuticalsActive, not recruitingFamilial Hypercholesterolemia - HomozygousGreece, Lebanon, Turkey, France, Canada, Malaysia, Netherlands, United States
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Novartis PharmaceuticalsRecruitingHeterozygous or Homozygous Familial HypercholesterolemiaNetherlands, Israel, Hungary, Italy, Germany, Spain, France, Norway, South Africa, Turkey, United Kingdom, Canada, Switzerland, Brazil, Lebanon, Slovenia, United States, Russian Federation, Taiwan
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Novartis PharmaceuticalsCompletedElevated Cholesterol | Homozygous Familial Hypercholesterolemia | Heterozygous Familial Hypercholesterolemia | ASCVDUnited States, Canada, Czechia, Denmark, Germany, Hungary, Netherlands, Poland, South Africa, Spain, Sweden, Ukraine, United Kingdom
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REGENXBIO Inc.National Heart, Lung, and Blood Institute (NHLBI)TerminatedHomozygous Familial Hypercholesterolemia (HoFH)United States, Canada, Italy, Netherlands
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Organon and CoCompletedPrimary Hypercholesterolemia | Homozygous Familial Hypercholesterolemia
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University of British ColumbiaVancouver Coastal Health Research Institute; Genome British ColumbiaRecruitingAcute Coronary Syndrome | Familial Hypercholesterolemia | STEMI | NSTEMI - Non-ST Segment Elevation MI | Familial Hypercholesterolemia - Heterozygous | Familial Hypercholesterolemia Due to Genetic Defect of Apolipoprotein B | Familial Hypercholesterolemia Due to Heterozygous LDL Receptor Mutation and other conditionsCanada
Clinical Trials on Implitapide
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Medical Research Laboratories InternationalTerminatedFamilial HypercholesterolemiaIsrael, Netherlands, United States, Canada, Norway
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Medical Research Laboratories InternationalTerminatedHypertriglyceridemiaUnited States, Netherlands, Norway