Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00079846
• Date of registration: 17/03/2004
• Prospective Registration: No
• Primary sponsor: Medical Research Laboratories International
• Public title: Implitapide in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
• Scientific title: Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Homozygous Familial Hypercholesterolemia (HoFH) on Maximal Concurrent Lipid-Lowering Therapy
• Date of first enrolment: September 2003
• Target sample size: 60
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00079846
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Canada, Israel, Netherlands, Norway, United States

Key inclusion & exclusion 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 a diagnosis of HoFH;

- 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 and height 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;

- 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;

- history of or 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.



Age minimum: 8 Years
Age maximum: 70 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Familial Hypercholesterolemia

Intervention(s)

Drug: Implitapide

Secondary ID(s)

MRL 2002-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors