Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) 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 Homozygous Familial Hypercholesterolemia (HoFH) 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 homozygous familial hypercholesterolemia (HoFH).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

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

  • Canada
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie
      • Sainte-Foy, Quebec, Canada, G1V 4G2
        • Lipid Research Center, CHUL du CHUQ
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah University Hospital
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center Amsterdam
  • Norway
      • Oslo, Norway, N-0027
        • Lipidklinikken - Rikshospitalet
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Metabolic and Atherosclerosis Research Center

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

8 years to 70 years (Child, 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 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.

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.

Sponsor

Medical Research Laboratories International

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

September 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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRL 2002-001

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.

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