NCT00216463

Safety and Tolerability of Varying Load and Dose of ISIS 301012 in People With Elevated LDL-cholesterol Levels

A Phase 2, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Varying Loading and Maintenance Dosing Regimens of ISIS 301012 Administered to Hypercholesterolemic Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Kastle Therapeutics, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the safety and tolerability of varying dose and load regimens of ISIS 301012 in people who have elevated LDL-cholesterol levels.

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	ISIS 301012 or Placebo	200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 200 mg subcutaneous injection - every other week for 11 weeks
DRUG	ISIS 301012 or Placebo	200 mg subcutaneous injection - 4 loading doses within the first 11 days followed by: 100 mg subcutaneous injection - every other week for 11 weeks
DRUG	ISIS 301012 or Placebo	300 mg subcutaneous injection - every week for 13 weeks
DRUG	ISIS 301012 or Placebo	400 mg subcutaneous injection - every week for 13 weeks
DRUG	ISIS 301012 or Placebo	200 mg subcutaneous injection - every week for 13 weeks

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-03-01
• Completion: 2007-08-01
• First posted: 2005-09-22
• Last updated: 2016-08-03

Locations

1 site across 1 country: Germany