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

Hypertriglyceridemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00080132
• Other study ID #: MRL 2002-003
• Status: Terminated
• Phase: Phase 2
• First received: March 23, 2004
• Last updated: June 23, 2005
• Start date: October 2004
• Est. completion date: April 2005

Study information

• Verified date: April 2005
• Source: Medical Research Laboratories International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertriglyceridemia

Intervention

Drug:
• implitapide

Locations

Country	Name	City	State
Netherlands	Academic Medical Center Amsterdam	Amsterdam
Netherlands	Andromed Noord	Groningen
Netherlands	Andromed Leiden	Leiden
Netherlands	Andromed Rotterdam	Rotterdam
Netherlands	Andromed Oost	Velp
Netherlands	Andromed Zoetermeer	Zoetermeer
Norway	Lipidklinikken - Rikshospitalet	Oslo
United States	Metabolic and Atherosclerosis Research Center	Cincinnati	Ohio
United States	The Methodist Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Laboratories International

Countries where clinical trial is conducted

United States,  Netherlands,  Norway,