Status:
TERMINATED
Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Lead Sponsor:
Medical Research Laboratories International
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
8-70 years
Phase:
PHASE2
Brief 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 med...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00080132
Start Date
October 1 2004
End Date
April 1 2005
Last Update
June 24 2005
Active Locations (9)
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1
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45229
2
The Methodist Hospital
Houston, Texas, United States, 77030
3
Academic Medical Center Amsterdam
Amsterdam, Netherlands, 1105 AZ
4
Andromed Noord
Groningen, Netherlands, 9711 SG