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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00079846

Enrollment

Registered

2004-03-18

Start date

2003-09-30

Completion date

2005-04-30

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Familial Hypercholesterolemia

Keywords

Homozygous Familial Hypercholesterolemia (HoFH)

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 cholesterol (LDL-C) in patients with homozygous familial hypercholesterolemia (HoFH).

Interventions

DRUGImplitapide

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

8 Years to 70 Years

Healthy volunteers

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

Countries

Canada, Israel, Netherlands, Norway, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026