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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in patients with Hypertriglyceridemia

Official Title

The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia

Keywords

Hypertriglyceridemia

Eligibility

You can join if…

Open to people ages 18 years and up

  1. BMI ≤ 45 kg/m2
  2. Fasting TG ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
  3. If on statin or fibrate, patients must be on stable, labeled dose for at least 3 months prior to screening. Patients not receiving these drugs within 4 weeks prior to screening are also eligible.

You CAN'T join if...

  1. Type 1 diabetes mellitus
  2. Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥9.0% at Screening
  3. Acute pancreatitis within 3 months of screening
  4. Acute Coronary Syndrome within 6 months of screening
  5. Major surgery within 3 months of screening
  6. Prior exposure to ISIS 304801
  7. Have any other conditions in the opinion of the investigator which could interfere with the patient participating in or completing the study

Locations

  • IONIS Investigative Site
    Encinitas, California, 92024, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Ionis Pharmaceuticals, Inc.
ID
NCT02300233
Phase
Phase 3
Study Type
Interventional
Last Updated
May 2016