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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00079846
Other study ID # MRL 2002-001
Secondary ID
Status Terminated
Phase Phase 2
First received March 17, 2004
Last updated June 23, 2005
Start date September 2003
Est. completion date April 2005

Study information

Verified date April 2005
Source Medical Research Laboratories International
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 homozygous familial hypercholesterolemia (HoFH).


Recruitment information / eligibility

Status Terminated
Enrollment 60
Est. completion date April 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
Implitapide


Locations

Country Name City State
Canada Lipid Clinic and Community Genomic Center, Complexe Hospitalier de la Sagamie Chicoutimi Quebec
Canada Lipid Research Center, CHUL du CHUQ Sainte-Foy Quebec
Israel Hadassah University Hospital Jerusalem
Netherlands Academic Medical Center Amsterdam Amsterdam
Norway Lipidklinikken - Rikshospitalet Oslo
United States Metabolic and Atherosclerosis Research Center Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
Medical Research Laboratories International

Countries where clinical trial is conducted

United States,  Canada,  Israel,  Netherlands,  Norway, 

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