Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

June 23, 2005 updated by: Medical Research Laboratories International

An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

The purpose of this study is to determine if implitapide is effective in lowering triglyceride (TG) levels in patients with Fredrickson Type I or V hypertriglyceridemia where the maximum tolerable medication and diet were not sufficient.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

50

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

  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Academic Medical Center Amsterdam
      • Groningen, Netherlands, 9711 SG
        • Andromed Noord
      • Leiden, Netherlands, 2311 GZ
        • Andromed Leiden
      • Rotterdam, Netherlands, 3021 HC
        • Andromed Rotterdam
      • Velp, Netherlands, 6883 HM
        • Andromed Oost
      • Zoetermeer, Netherlands, 2724 EK
        • Andromed Zoetermeer
  • Norway
      • Oslo, Norway
        • Lipidklinikken - Rikshospitalet
  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Metabolic and Atherosclerosis Research Center
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital

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 diagnosis of Fredrickson Type I or V HTG
  • be stable on current maximum tolerated triglyceride lowering therapy
  • have a fasting TG level of at least 880 mg/dL (10 mmol/L)
  • be male or nonpregnant, nonbreastfeeding female. The women in the study must be surgically sterile, postmenopausal or must practice an effective method of birth control
  • must be able to give informed consent or if under the age of 18, parents or legal guardians must give their informed consent
  • meet body weight requirements

Exclusion Criteria:

  • Recent heart attack, coronary artery intervention, coronary bypass surgery, or stroke.
  • Patients with class 3 or 4 heart failure
  • Uncontrolled hypothyroidism or other uncontrolled endocrine disease
  • Known, clinically significant eye abnormalities, such as cataracts
  • History of hepatic disease or AST or ALT levels greater than 1.5 x ULN at Visit 1
  • Alkaline phosphatase greater than 2 times ULN
  • Serum creatinine greater than 2.0 mg/dL
  • Liver cirrhosis and severe liver steatosis
  • Clinically significant infection, malignancy, or psychosis
  • Use of oral anticoagulants or digoxin unless the dose is stable and is regularly monitored
  • Participation in any other investigational study within the last 30 days
  • Breastfeeding or pregnant
  • Current drug or alcohol abuse
  • Serious or unstable medical conditions that would compromise the patient's safety or successful participation in the study
  • Unwillingness to comply with study procedures or unwillingness to cooperate fully

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
  • Masking: None (Open Label)

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

October 1, 2004

Study Completion

April 1, 2005

Study Registration Dates

First Submitted

March 23, 2004

First Submitted That Met QC Criteria

March 24, 2004

First Posted (Estimate)

March 25, 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 2002-003

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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