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Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

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ClinicalTrials.gov Identifier: NCT00079859
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 heterozygous familial hypercholesterolemia (HeFH).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 120 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 Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Study Start Date : October 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:   18 Years to 70 Years   (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 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
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): NCT00079859


Locations
United States, Ohio
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45229
Netherlands
Andromed Leiden
Leiden, Netherlands
Andromed Rotterdam
Rotterdam, Netherlands
Andromed Oost
Velp, Netherlands
Andromed Zoetermeer
Zoetermeer, Netherlands
Norway
Lipidklinikken - Rikshospitalet
Oslo, Norway
Sponsors and Collaborators
Medical Research Laboratories International
More Information
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ClinicalTrials.gov Identifier: NCT00079859     History of Changes
Other Study ID Numbers: MRL 2002-002
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:
Heterozygous Familial Hypercholesterolemia (HeFH)

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