Overview

This trial is active, not recruiting.

Condition hypertriglyceridemia
Treatments volanesorsen, placebo
Phase phase 3
Sponsor Ionis Pharmaceuticals, Inc.
Collaborator Akcea Therapeutics
Start date December 2014
End date December 2016
Trial size 114 participants
Trial identifier NCT02300233, ISIS 304801-CS16

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
volanesorsen
300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks
(Placebo Comparator)
placebo
Placebo administered subcutaneously once-weekly for 26 weeks

Primary Outcomes

Measure
The percent change in fasting triglycerides (TG) from baseline
time frame: Baseline and 13 Weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title The COMPASS Study: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of ISIS 304801 Administered Subcutaneously to Patients With Hypertriglyceridemia
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc..