Suspended

Implitapide and Lipid-Lowering Therapies for HeFH LDL-C Reduction

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What is being tested

Data Collection

Who is being recruted

Hyperlipoproteinemia Type II+8

+ Hyperlipidemias

+ Hyperlipoproteinemias

From 18 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: October 2003
See protocol details

Summary

Principal SponsorMedical Research Laboratories International
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2003

Actual date on which the first participant was enrolled.

This study focuses on a specific group of individuals who have a condition called heterozygous familial hypercholesterolemia (HeFH). This condition causes high levels of a certain type of cholesterol, known as LDL-C. The goal of the study is to find out if a drug named implitapide, when used alongside other cholesterol-lowering treatments, can safely and effectively reduce these LDL-C levels. The importance of this study lies in its potential to improve treatment options for people with HeFH, helping them manage their cholesterol levels better.

Official TitleSafety and Efficacy Study of Implitapide Compared With Placebo in Patients With Heterozygous Familial Hypercholesterolemia (HeFH) on Maximal Concurrent Lipid-Lowering Therapy
NCT00079859
Principal SponsorMedical Research Laboratories International
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hyperlipoproteinemia Type IIHyperlipidemiasHyperlipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesGenetic Diseases, InbornDyslipidemiasLipid Metabolism Disorders

Criteria

6 inclusion criteria required to participate
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
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13 exclusion criteria prevent from participating
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)
history of liver disease or liver enzyme levels above appropriate levels
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 6 locations

Suspended

Lipidklinikken - Rikshospitalet

Oslo, NorwayOpen Lipidklinikken - Rikshospitalet in Google Maps
Suspended

Metabolic and Atherosclerosis Research Center

Cincinnati, United States
Suspended

Andromed Leiden

Leiden, Netherlands
Suspended

Andromed Rotterdam

Rotterdam, Netherlands
Suspended6 Study Centers