An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Data Collection
Hyperlipidemias+2
+ Metabolic Diseases
+ Hypertriglyceridemia
Treatment Study
Summary
Study start date: October 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 8 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 9 locations
The Methodist Hospital
Houston, United StatesAcademic Medical Center Amsterdam
Amsterdam, NetherlandsAndromed Noord
Groningen, Netherlands