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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02300233
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : May 9, 2018
Sponsor:
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: volanesorsen Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
Actual Study Start Date : February 5, 2015
Actual Primary Completion Date : July 27, 2016
Actual Study Completion Date : January 24, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Active Comparator: volanesorsen Drug: volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks

Placebo Comparator: Placebo Drug: Placebo
Placebo administered subcutaneously once-weekly for 26 weeks




Primary Outcome Measures :
  1. The percent change in fasting triglycerides (TG) from baseline [ Time Frame: Baseline and 13 Weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300233


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Locations
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United States, California
IONIS Investigative Site
Encinitas, California, United States, 92024
IONIS Investigative Site
San Francisco, California, United States, 94143
United States, Florida
IONIS Investigative Site
Boca Raton, Florida, United States, 33434
IONIS Investigative Site
Miami, Florida, United States, 33147
United States, Illinois
IONIS Investigative Site
Sterling, Illinois, United States, 61081
United States, Kansas
IONIS Investigative Site
Kansas City, Kansas, United States, 66160
United States, Maryland
IONIS Investigative Site
Salisbury, Maryland, United States, 73103
IONIS Investigative Site
Towson, Maryland, United States, 21204
United States, Massachusetts
IONIS Investigative Site
Boston, Massachusetts, United States, 02114
United States, Michigan
IONIS Investigative Site
Grandville, Michigan, United States, 49418
United States, New York
IONIS Investigative Site
North Massapequa, New York, United States, 11758-1802
United States, North Carolina
IONIS Investigative Site
Benson, North Carolina, United States, 27504
IONIS Investigative Site
Chapel Hill, North Carolina, United States, 27609
IONIS Investigative Site
Farmville, North Carolina, United States, 27828
IONIS Investigative Site
Greenville, North Carolina, United States, 27834
IONIS Investigative Site
Morrisville, North Carolina, United States, 27560
IONIS Investigative Site
Raleigh, North Carolina, United States, 27612
IONIS Investigative Site
Wilson, North Carolina, United States, 27609
IONIS Investigative Site
Wilson, North Carolina, United States, 27893
United States, Ohio
IONIS Investigative Site
Cincinnati, Ohio, United States, 45227
IONIS Investigative Site
Kettering, Ohio, United States, 45429
IONIS Investigative Site
Marion, Ohio, United States, 43302
United States, Oklahoma
IONIS Investigative Site
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
IONIS Investigative Site
Portland, Oregon, United States, 97239
United States, Rhode Island
IONIS Investigative Site
Providence, Rhode Island, United States, 02906
United States, Texas
IONIS Investigative Site
Houston, Texas, United States, 77030
United States, Utah
IONIS Investigative Site
Salt Lake City, Utah, United States, 84108
United States, Virginia
IONIS Investigative Site
Norfolk, Virginia, United States, 23510
United States, Washington
IONIS Investigative Site
Seattle, Washington, United States, 98104
Canada, British Columbia
IONIS Investigative Site
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
IONIS Investigative Site
London, Ontario, Canada, N6A 5B7
Canada, Quebec
IONIS Investigative Site
Chicoutimi, Quebec, Canada, G7H 7K9
IONIS Investigative Site
Sainte-Foy, Quebec, Canada, G1V 4M6
France
IONIS Investigative Site
Dijon, France, 21079
IONIS Investigative Site
Marseille, France, 13385
IONIS Investigative Site
Paris, France, 75013
IONIS Investigative Site
Saint Herblain, France
Germany
IONIS Investigative Site
Koeln, North Rhine-Westphalia, Germany, 50937
IONIS Investigative Site
Berlin, Germany, 13353
IONIS Investigative Site
Dresden, Germany, 01307
Netherlands
IONIS Investigative Site
Amsterdam, North Holland, Netherlands, 1105 AZ
IONIS Investigative Site
Rotterdam, South Holland, Netherlands, 3045 PM
IONIS Investigative Site
Utrecht, Netherlands, 3584 CX
United Kingdom
IONIS Investigative Site
Manchester, United Kingdom, M23 9LT
IONIS Investigative Site
Peterborough, United Kingdom, PE3 6DA
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Akcea Therapeutics

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Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02300233     History of Changes
Other Study ID Numbers: ISIS 304801-CS16
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases