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Implitapide in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

NCT ID: NCT00079859

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-10-31

Study Completion Date

2005-04-30

Brief Summary

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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).

Detailed Description

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Conditions

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Familial Hypercholesterolemia

Keywords

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Heterozygous Familial Hypercholesterolemia (HeFH)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Implitapide

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Research Laboratories International

INDUSTRY

Sponsor Role lead

Locations

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Metabolic and Atherosclerosis Research Center

Cincinnati, Ohio, United States

Site Status

Andromed Leiden

Leiden, , Netherlands

Site Status

Andromed Rotterdam

Rotterdam, , Netherlands

Site Status

Andromed Oost

Velp, , Netherlands

Site Status

Andromed Zoetermeer

Zoetermeer, , Netherlands

Site Status

Lipidklinikken - Rikshospitalet

Oslo, , Norway

Site Status

Countries

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United States Netherlands Norway

Other Identifiers

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MRL 2002-002

Identifier Type: -

Identifier Source: org_study_id