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
Farmville, North Carolina 27828
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Farmville, NC
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Benson, North Carolina 27504
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Benson, NC
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Boca Raton, Florida 33434
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Boca Raton, FL
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Boston, Massachusetts 02114
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Boston, MA
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Chapel Hill, North Carolina 27609
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Chapel Hill, NC
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Cincinnati, Ohio 45227
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Cincinnati, OH
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Encinitas, California 92024
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Encinitas, CA
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Grandville, Michigan 49418
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Grandville, MI
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Greenville, North Carolina 27834
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Greenville, NC
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Houston, Texas 77030
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Houston, TX
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Kansas City, Kansas 66160
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Kansas City, KS
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Kettering, Ohio 45429
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Kettering, OH
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Marion, Ohio 43302
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Marion, OH
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Miami, Florida 33147
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Miami, FL
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Morrisville, North Carolina 27560
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Morrisville, NC
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Norfolk, Virginia 23510
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Norfolk, VA
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North Massapequa, New York 11758
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North Massapequa, NY
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Oklahoma City, Oklahoma 73103
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Oklahoma City, OK
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Portland, Oregon 97239
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Portland, OR
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Providence, Rhode Island 02906
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Providence, RI
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Raleigh, North Carolina 27612
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Raleigh, NC
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Salisbury, Maryland 73103
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Salisbury, MD
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Salt Lake City, Utah 84108
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Salt Lake City, UT
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San Francisco, California 94143
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San Francisco, CA
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Seattle, Washington 98104
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Seattle, WA
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Sterling, Illinois 61081
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Sterling, IL
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Towson, Maryland 21204
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Towson, MD
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Vancouver, British Columbia
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Vancouver,
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Wilson, North Carolina 27609
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Wilson, NC
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Wilson, North Carolina 27609
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Wilson, NC
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