NCT00079859

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 heterozygous familial hypercholesterolemia (HeFH).

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2003

Shorter than P25 for phase_2

Geographic Reach
3 countries

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2004

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
Last Updated

June 24, 2005

Status Verified

April 1, 2005

First QC Date

March 17, 2004

Last Update Submit

June 23, 2005

Conditions

Familial Hypercholesterolemia

Keywords

Heterozygous Familial Hypercholesterolemia (HeFH)

Interventions

ImplitapideDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Metabolic and Atherosclerosis Research Center

Cincinnati, Ohio, 45229, United States

Location

Andromed Leiden

Leiden, Netherlands

Location

Andromed Rotterdam

Rotterdam, Netherlands

Location

Andromed Oost

Velp, Netherlands

Location

Andromed Zoetermeer

Zoetermeer, Netherlands

Location

Lipidklinikken - Rikshospitalet

Oslo, Norway

Location

MeSH Terms

Conditions

Hyperlipoproteinemia Type II

Interventions

implitapide

Condition Hierarchy (Ancestors)

Lipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHyperlipoproteinemiasHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 17, 2004

First Posted

March 18, 2004

Study Start

October 1, 2003

Study Completion

April 1, 2005

Last Updated

June 24, 2005

Record last verified: 2005-04

Locations

US(1)NL(4)NO(1)