Status:
COMPLETED
The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Collaborating Sponsors:
Akcea Therapeutics
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in participants with Hypertriglyceridemia.
Eligibility Criteria
Inclusion
- Body mass index (BMI) ≤ 45 kg/m2
- Fasting Triglycerides (TG) ≥ 500 mg/dL (≥ 5.7 mmol/L) at Screening.
- If on statin or fibrate, participants must be on stable, labeled dose for at least 3 months prior to screening. Participants not receiving these drugs within 4 weeks prior to screening are also eligible.
Exclusion
- Type 1 diabetes mellitus
- Newly diagnosed type 2 diabetes mellitus (within 12 weeks of screening) or HbA1c ≥ 9.0% at Screening
- Acute pancreatitis within 3 months of screening
- Acute Coronary Syndrome within 6 months of screening
- Major surgery within 3 months of screening
- Prior exposure to ISIS 304801
- Have any other conditions in the opinion of the investigator which could interfere with the participant participating in or completing the study
Key Trial Info
Start Date :
February 5 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2017
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT02300233
Start Date
February 5 2015
End Date
January 24 2017
Last Update
April 13 2022
Active Locations (45)
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1
IONIS Investigative Site
Encinitas, California, United States, 92024
2
IONIS Investigative Site
San Francisco, California, United States, 94143
3
IONIS Investigative Site
Boca Raton, Florida, United States, 33434
4
IONIS Investigative Site
Miami, Florida, United States, 33147