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Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

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ClinicalTrials.gov Identifier: NCT00079846
Recruitment Status : Terminated
First Posted : March 18, 2004
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Medical Research Laboratories International

Study Description
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Brief 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 homozygous familial hypercholesterolemia (HoFH).

Condition or disease Intervention/treatment Phase
Familial Hypercholesterolemia Drug: Implitapide Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
Study Start Date : September 2003
Study Completion Date : April 2005

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   8 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

In order to participate in this study, patients must meet all of the following inclusion criteria:

  • be between 8 and 70 years old with a diagnosis of HoFH;
  • 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 and height 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;
  • 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;
  • history of or 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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079846


Locations
United States, Ohio
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45229
Canada, Quebec
Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie
Chicoutimi, Quebec, Canada, G7H 5H6
Lipid Research Center, CHUL du CHUQ
Sainte-Foy, Quebec, Canada, G1V 4G2
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Netherlands
Academic Medical Center Amsterdam
Amsterdam, Netherlands, 1105 AZ
Norway
Lipidklinikken - Rikshospitalet
Oslo, Norway, N-0027
Sponsors and Collaborators
Medical Research Laboratories International
More Information
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ClinicalTrials.gov Identifier: NCT00079846     History of Changes
Other Study ID Numbers: MRL 2002-001
First Posted: March 18, 2004    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: April 2005

Keywords provided by Medical Research Laboratories International:
Homozygous Familial Hypercholesterolemia (HoFH)

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Lipid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Hyperlipoproteinemias