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NCT01556906 · ClinicalTrials.gov registry record · Phase 2

Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor

A Phase 2 study of Homozygous Familial Hypercholesterolemia, sponsored by Aegerion Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
6
Enrollment target
1
Study location

NCT01556906: Completed Phase 2 study of Homozygous Familial Hypercholesterolemia, sponsored by Aegerion Pharmaceuticals.

NCT01556906 is a Phase 2 study of Homozygous Familial Hypercholesterolemia that has completed, run by Aegerion Pharmaceuticals. The registered enrollment target is 6 participants, below the 251-participant average among 6 other Homozygous Familial Hypercholesterolemia trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01556906, a Phase 2 study of Homozygous Familial Hypercholesterolemia, has completed, sponsored by Aegerion Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
6 participants
Enrollment target
1
Study location

Study Summary

The primary objective of this study is to evaluate the safety and tolerability of 4 doses of lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an additional 3 dose levels over a 16-week period. The secondary objectives of this study included the evaluation of the pharmacodynamics of lomitapide based on: * Percent change in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), triglycerides, and very low density lipoprotein cholesterol (VLDL-C) concentrations at the end of each 4-week dosing period compared to the Baseline value of each parameter at the end of the previous dose phase(s). * Changes in other plasma lipoproteins: apolipoproteins (apo B, apo AI, apo AII, apo CIII, apo E) and lipoprotein a \[Lp(a)\].

Primary Outcome

Percent change in LDL-C compared to Baseline.

Conditions Studied

Homozygous Familial Hypercholesterolemia

Interventions

  • DRUG Lomitapide

Study Locations (1)

Pennsylvania

  • University of Pennsylvania - Philadelphia

Trial Details

FieldValue
Enrollment Target 6 participants
Start Date 2003-06
Est. Completion 2004-02
Phase Phase 2
Aegerion Pharmaceuticals

11 total trials

What the finished NCT01556906 record still lists

NCT01556906 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 251-participant average among 6 other Homozygous Familial Hypercholesterolemia trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Homozygous Familial Hypercholesterolemia appearing as the primary indexed condition, and to 1 intervention - of which Lomitapide is the first listed.

NCT01556906 reports a single indexed study location in Pennsylvania.

Frequently Asked Questions

What is clinical trial NCT01556906 about?

NCT01556906 is a clinical study titled "Safety, Tolerability and Efficacy of Microsomal Triglyceride Protein (MTP) Inhibitor". The primary objective of this study is to evaluate the safety and tolerability of 4 doses of lomitapide (AEGR-733; BMS-201038) given as an initial low dose and then escalated through an additional 3 dose levels over a 16-week period. The secondary objectives of this study included the evaluation of...

What is the current status of trial NCT01556906?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 6 participants. The study started on 2003-06. Estimated completion is 2004-02.

What conditions does trial NCT01556906 study?

This clinical trial studies the following conditions: Homozygous Familial Hypercholesterolemia.

What interventions are being tested in trial NCT01556906?

The interventions under investigation include: Lomitapide (DRUG).

Who is sponsoring clinical trial NCT01556906?

This trial is sponsored by Aegerion Pharmaceuticals, which has 11 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01556906 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Related registry views

Source: ClinicalTrials.gov NCT01556906, the US trial registry maintained by the National Library of Medicine. NCT01556906 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.