Clinical trial NCT00079859: Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Official title: Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Familial Hypercholesterolemia
Keywords: Heterozygous Familial Hypercholesterolemia (HeFH)
Lead sponsor: Medical Research Laboratories International
Sponsor class: INDUSTRY
First posted: 2004-03-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if implitapide, used in conjunction with other lipid-lowering therapies, is safe and effective when compared to placebo in lowering low-density lipoprotein cholesterol (LDL-C) in patients with heterozygous familial hypercholesterolemia (HeFH).


Eligibility criteria: Inclusion Criteria:

In order to participate in this study, patients must meet all of the following inclusion criteria:

* be between 18 and 70 years old with a diagnosis of HeFH;
* be stable on and maintain concomitant therapy with hypolipidemic drugs or treatments;
* have an appropriate calculated, fasting LDL-C levels and an appropriate triglyceride (TG) level;
* be male or nonpregnant, nonlactating female;
* give informed consent; and
* meet body weight requirements.

Exclusion Criteria:

In order to participate in this study, patients must not meet any of the following exclusion criteria:

* recent myocardial infarction, percutaneous transluminal coronary intervention, coronary artery bypass graft surgery, or cerebrovascular accident;
* uncontrolled hypothyroidism or other uncontrolled endocrine disease;
* known, clinically significant eye abnormalities (e.g., cataracts);
* appropriate serum creatinine phosphokinase levels;
* history of liver disease or liver enzyme levels above appropriate levels;
* alkaline phosphatase above appropriate levels;
* serum creatinine above appropriate levels;
* liver cirrhosis and severe liver steatosis;
* clinically significant infection, malignancy, or psychosis;
* use of oral anticoagulants or digoxin, unless the dose has been stable for 4 weeks;
* participation in any other investigational study, including device or observational studies, within 30 days;
* lactating or have a positive serum pregnancy test;
* current drug or alcohol abuse; or
* unwillingness to comply with study procedures, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the investigator

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Metabolic and Atherosclerosis Research Center
state: Ohio
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: