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

Familial Hypercholesterolemia Clinical Trial

Official title:

Safety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00079859
• Other study ID #: MRL 2002-002
• Status: Terminated
• Phase: Phase 2
• First received: March 17, 2004
• Last updated: June 23, 2005
• Start date: October 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 heterozygous familial hypercholesterolemia (HeFH).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 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 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

Study Design

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

Related Conditions & MeSH terms

• Familial Hypercholesterolemia
• Hypercholesterolemia
• Hyperlipoproteinemia Type II

Intervention

Drug:
• Implitapide

Locations

Country	Name	City	State
Netherlands	Andromed Leiden	Leiden
Netherlands	Andromed Rotterdam	Rotterdam
Netherlands	Andromed Oost	Velp
Netherlands	Andromed Zoetermeer	Zoetermeer
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,  Netherlands,  Norway,