The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia



Status:Completed
Conditions:High Cholesterol, Metabolic
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:18 - Any
Updated:5/11/2018
Start Date:February 5, 2015
End Date:January 24, 2017

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

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


Inclusion Criteria:

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.

Exclusion Criteria:

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
We found this trial at
30
sites
Morrisville, North Carolina 27560
366
mi
from 43215
Morrisville, NC
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Benson, North Carolina 27504
400
mi
from 43215
Benson, NC
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Boca Raton, Florida 33434
955
mi
from 43215
Boca Raton, FL
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Boston, Massachusetts 02114
643
mi
from 43215
Boston, MA
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Chapel Hill, North Carolina 27609
374
mi
from 43215
Chapel Hill, NC
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Cincinnati, Ohio 45227
94
mi
from 43215
Cincinnati, OH
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Encinitas, California 92024
1949
mi
from 43215
Encinitas, CA
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Farmville, North Carolina 27828
423
mi
from 43215
Farmville, NC
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Grandville, Michigan 49418
247
mi
from 43215
Grandville, MI
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Greenville, North Carolina 27834
430
mi
from 43215
Greenville, NC
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Houston, Texas 77030
991
mi
from 43215
Houston, TX
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Kansas City, Kansas 66160
620
mi
from 43215
Kansas City, KS
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Kettering, Ohio 45429
63
mi
from 43215
Kettering, OH
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Marion, Ohio 43302
43
mi
from 43215
Marion, OH
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Miami, Florida 33147
993
mi
from 43215
Miami, FL
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Norfolk, Virginia 23510
423
mi
from 43215
Norfolk, VA
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North Massapequa, New York 11758
505
mi
from 43215
North Massapequa, NY
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Oklahoma City, Oklahoma 73103
849
mi
from 43215
Oklahoma City, OK
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Portland, Oregon 97239
2026
mi
from 43215
Portland, OR
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Providence, Rhode Island 02906
619
mi
from 43215
Providence, RI
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Raleigh, North Carolina 27612
369
mi
from 43215
Raleigh, NC
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Salisbury, Maryland 73103
849
mi
from 43215
Salisbury, MD
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Salt Lake City, Utah 84108
1513
mi
from 43215
Salt Lake City, UT
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San Francisco, California 94143
1982
mi
from 43215
San Francisco, CA
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Seattle, Washington 98104
2006
mi
from 43215
Seattle, WA
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Sterling, Illinois 61081
370
mi
from 43215
Sterling, IL
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Towson, Maryland 21204
341
mi
from 43215
Towson, MD
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Vancouver, British Columbia
2046
mi
from 43215
Vancouver,
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Wilson, North Carolina 27609
372
mi
from 43215
Wilson, NC
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Wilson, North Carolina 27609
372
mi
from 43215
Wilson, NC
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