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Trial record 1 of 2 for:    isis compass
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The COMPASS Study: A Study of Volanesorsen (Formally ISIS-APOCIIIRx) in Patients With Hypertriglyceridemia

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02300233
First Posted: November 24, 2014
Last Update Posted: May 25, 2016
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.
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.
  Purpose
The purpose of this study is to evaluate the efficacy and safety of volanesorsen given for 26 weeks in patients with Hypertriglyceridemia

Condition Intervention Phase
Hypertriglyceridemia Drug: volanesorsen Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Ionis Pharmaceuticals, Inc.:

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

Enrollment: 114
Study Start Date: December 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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


  Show 45 Study Locations
Sponsors and Collaborators
Ionis Pharmaceuticals, Inc.
Akcea Therapeutics
  More Information

Responsible Party: Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02300233     History of Changes
Other Study ID Numbers: ISIS 304801-CS16
First Submitted: November 20, 2014
First Posted: November 24, 2014
Last Update Posted: May 25, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases


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