A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study ofISIS 304801 Administered Subcutaneously to Patients withHypertriglyceridemia - The COMPASS Study

Ionis Pharmaceuticals, Inc.0 个研究点目标入组 105 人开始时间: 2015年7月9日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•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.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 90
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•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. Gastric banding procedure within 1 year of screening
•6. Malignancy within 5 years, except for basal or squamous cell carcinoma of the skin of carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated
•7. Treatment with another investigational drug, biological agent, or device within one month of screening.
•8. Prior exposure to ISIS 304801
•9. Have any other conditions in the opinion of the investigator which could interfere with the patient participating in our completing the study

发起方