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NCT00694109 · ClinicalTrials.gov registry record · Phase 3

An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia

A Phase 3 study of Hyperlipidemias and Metabolic Diseases, sponsored by Kastle Therapeutics.

Completed
Registry status
Phase 3
Development phase
144
Enrollment target
20
Study locations

NCT00694109 is a Phase 3 study of Hyperlipidemias and Metabolic Diseases that has completed, run by Kastle Therapeutics. The registered enrollment target is 144 participants, below the 4,014-participant average among 21 other Hyperlipidemias trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT00694109, a Phase 3 study of Hyperlipidemias and Metabolic Diseases, has completed, sponsored by Kastle Therapeutics.

COMPLETED
Registry status
Phase 3
Development phase
144 participants
Enrollment target
20
Study locations

Study Summary

To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) or MIPO3500108 (NCT00794664) clinical drug trials.

Conditions Studied

Hyperlipidemias Metabolic Diseases Infant, Newborn, Diseases Congenital Abnormalities Genetic Diseases, Inborn Metabolic Disorder Metabolism, Inborn Errors Lipid Metabolism, Inborn Errors Hypercholesterolemia, Autosomal Dominant Hyperlipoproteinemia Type II

Interventions

  • DRUG Mipomersen Sodium

Study Locations (20)

California

  • - Mission Viejo
  • - Newport Beach

Florida

  • - Melbourne
  • - Winter Park

North Carolina

  • - Charlotte
  • - Durham

Ohio

  • - Cincinnati
  • - Franklin

Connecticut

  • - Bridgeport

Illinois

  • - Chicago

Kansas

  • - Kansas City

Maine

  • - Biddeford

Trial Details

FieldValue
Enrollment Target 144 participants
Start Date 2008-04
Est. Completion 2014-09
Phase Phase 3

Sponsor

Kastle Therapeutics

13 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00694109

The ClinicalTrials.gov registry entry for NCT00694109 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,014-participant average among 21 other Hyperlipidemias trials with a reported enrollment target (96% lower). The listed sponsor is Kastle Therapeutics, which has 13 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Hyperlipidemias appearing as the primary indexed condition, and to 1 intervention - of which Mipomersen Sodium is the first listed.

NCT00694109 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Florida, North Carolina.

Frequently Asked Questions

What is clinical trial NCT00694109 about?

NCT00694109 is a clinical study titled "An Open-label Extension Study to Assess the Long-term Safety and Efficacy of ISIS 301012 (Mipomersen) in Patients With Familial Hypercholesterolemia or Severe-Hypercholesterolemia". To evaluate the safety and efficacy of extended dosing with mipomersen (ISIS 301012) in participants with familial hypercholesterolemia or severe hypercholesterolemia on lipid-lowering therapy who had completed either the 301012-CS5 (NCT00607373), 301012-CS7 (NCT00706849), 301012-CS17 (NCT00477594) ...

What is the current status of trial NCT00694109?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2008-04. Estimated completion is 2014-09.

What conditions does trial NCT00694109 study?

This clinical trial studies the following conditions: Hyperlipidemias, Metabolic Diseases, Infant, Newborn, Diseases, Congenital Abnormalities, Genetic Diseases, Inborn.

What interventions are being tested in trial NCT00694109?

The interventions under investigation include: Mipomersen Sodium (DRUG).

Who is sponsoring clinical trial NCT00694109?

This trial is sponsored by Kastle Therapeutics, which has 13 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00694109 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.