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Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
This study has been terminated.
First Received: March 23, 2004   Last Updated: June 23, 2005   History of Changes
Sponsored by: Medical Research Laboratories International
Information provided by: Medical Research Laboratories International
ClinicalTrials.gov Identifier: NCT00080132
  Purpose

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.


Condition Intervention Phase
Hypertriglyceridemia
Drug: implitapide
Phase II

Study Type: Interventional
Study Design: Treatment, Open Label, Safety/Efficacy Study
Official Title: An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy

Resource links provided by NLM:


Further study details as provided by Medical Research Laboratories International:

Estimated Enrollment: 50
Study Start Date: October 2004
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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080132

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

No publications provided

Study ID Numbers: MRL 2002-003
Study First Received: March 23, 2004
Last Updated: June 23, 2005
ClinicalTrials.gov Identifier: NCT00080132     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Medical Research Laboratories International:
HTG
Hypertriglyceridemia, Fredrickson Type I
Hypertriglyceridemia, Fredrickson Type V

Study placed in the following topic categories:
Metabolic Diseases
Hyperlipidemias
Hypertriglyceridemia
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:
Metabolic Diseases
Hyperlipidemias
Hypertriglyceridemia
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on September 10, 2009