Suspended

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

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What is being tested

Data Collection

Who is being recruted

Hypercholesterolemia
+7

+ Hyperlipoproteinemia Type II
+ Hyperlipidemias
From 18 to 70 Years
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 14, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2003Actual date on which the first participant was enrolled.

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).

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 14, 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Hypercholesterolemia
Hyperlipoproteinemia Type II
Hyperlipidemias
Hyperlipoproteinemias
Lipid Metabolism, Inborn Errors
Metabolic Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Dyslipidemias
Lipid Metabolism Disorders
Criteria

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 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
Metabolic and Atherosclerosis Research CenterCincinnati, United StatesSee the location
Suspended
Andromed LeidenLeiden, Netherlands
Suspended
Andromed RotterdamRotterdam, Netherlands
Suspended
Andromed OostVelp, Netherlands
Suspended6 Study Centers