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

• Status: Terminated
• Trial end date: 2005-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Laboratories International

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