Status:
TERMINATED
Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
Lead Sponsor:
Medical Research Laboratories International
Conditions:
Familial Hypercholesterolemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ch...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
End Date :
April 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00079859
Start Date
October 1 2003
End Date
April 1 2005
Last Update
June 24 2005
Active Locations (6)
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1
Metabolic and Atherosclerosis Research Center
Cincinnati, Ohio, United States, 45229
2
Andromed Leiden
Leiden, Netherlands
3
Andromed Rotterdam
Rotterdam, Netherlands
4
Andromed Oost
Velp, Netherlands