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

This study has been terminated.
Sponsor:
Information provided by:
Medical Research Laboratories International
ClinicalTrials.gov Identifier:
NCT00079846
First received: March 17, 2004
Last updated: June 23, 2005
Last verified: April 2005
  Purpose

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 Intervention Phase
Familial Hypercholesterolemia
Drug: Implitapide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Medical Research Laboratories International:

Estimated Enrollment: 60
Study Start Date: September 2003
Estimated Study Completion Date: April 2005
  Eligibility

Ages Eligible for Study:   8 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00079846     History of Changes
Other Study ID Numbers: MRL 2002-001
Study First Received: March 17, 2004
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 22, 2014