Clinical trial NCT00080132: Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Official title: An Open-Label, Dose-Escalating Efficacy and Safety Study of Implitapide in Patients With Hypertriglyceridemia (HTG) on Maximal, Concurrent Triglyceride-Lowering Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hypertriglyceridemia
Keywords: HTG
Hypertriglyceridemia, Fredrickson Type I
Hypertriglyceridemia, Fredrickson Type V
Lead sponsor: Medical Research Laboratories International
Sponsor class: INDUSTRY
First posted: 2004-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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 medication and diet were not sufficient.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Metabolic and Atherosclerosis Research Center
state: Ohio
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Amsterdam
country: Netherlands
facility: Academic Medical Center Amsterdam
city: Groningen
country: Netherlands
facility: Andromed Noord
city: Leiden
country: Netherlands
facility: Andromed Leiden
city: Rotterdam
country: Netherlands
facility: Andromed Rotterdam
city: Velp
country: Netherlands
facility: Andromed Oost
city: Zoetermeer
country: Netherlands
facility: Andromed Zoetermeer
city: Oslo
country: Norway
facility: Lipidklinikken - Rikshospitalet
Study officials:
References: