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Trial record 1 of 3 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:
Collaborator:
Akcea Therapeutics
Information provided by (Responsible Party):
Ionis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT02300233
First received: November 20, 2014
Last updated: May 24, 2016
Last verified: May 2016
  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: Double Blind (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: November 20, 2014
Last Updated: May 24, 2016

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

ClinicalTrials.gov processed this record on June 22, 2017