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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Baseline was defined as the last value prior to receiving the first dose of mipomersen in this study (for participants randomized to placebo in their index study and for participants randomized to mipomersen in their index study and their first dose of mipomersen in this study was administered \>=6 months from their last dose of mipomersen in their index study), or the last value prior to receiving the first dose of mipomersen in their index study (for participants randomized to mipomersen in th

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
Kastle Therapeutics

13 total trials

What the finished NCT00694109 record still lists

NCT00694109 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 4,014-participant average among 21 other Hyperlipidemias trials with a reported enrollment target (96% lower).

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 names 20 study sites across 16 states, led by 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.

Learn More About Clinical Trials

Similar trials for Hyperlipidemias

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00694109's enrollment target sits among peer trials

144 9th of 21 higher than 13 of 21 other Hyperlipidemias trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hyperlipidemias trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00694109, the US trial registry maintained by the National Library of Medicine. NCT00694109 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.