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 |
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
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
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