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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01529424
Other study ID # ISIS 304801-CS2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 2012
Est. completion date January 2014

Study information

Verified date January 2022
Source Ionis Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels.


Recruitment information / eligibility

Status Completed
Enrollment 89
Est. completion date January 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Severe hypertriglyceridemia Exclusion Criteria: - HbA1c >/=9.0%, type 1 diabetes, or history of outpatient insulin use for more than 2 weeks in the last year - Body mass index (BMI) >40 kg/m2 - History of bariatric surgery or currently on weight loss drugs - Use of oral contraceptives or hormone replacement therapy or statins unless stable for 3 months prior to dosing - Group 1 and 2 patients: Use of systemic corticosteroids, fibrates, niacin, fish oil or other products containing omega-3 fatty acids within 6 weeks of dosing. Group 3 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing ; use of niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. Group 4 patients: unable to discontinue use of systemic corticosteroids at least 6 weeks prior to dosing; use of fibrates niacin, fish oil, or other products containing omega-3 fatty acids unless on a stable well controlled dose for at least 30 days prior to screening that is not anticipated to change during the study period. - Use of topical corticosteroids, anticoagulants, or drugs or dietary supplements with potential lipid-altering effects unless dose is stable and well controlled for 30 days prior to dosing - Any Screening laboratory values that are out of allowed reference ranges - Inability to comply with protocol or study procedures - Any other significant illness or condition that may adversely affect the subjects participation in the study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
ISIS apoC-III Rx
Dose 1
ISIS apoC-III Rx
Dose 2
ISIS apoC-III Rx
Dose 3
Placebo
Dose 1
Placebo
Dose 2
Placebo
Dose 3

Locations

Country Name City State
Canada Isis Investigational site Chicoutimi Quebec
United States Farmville Internal Medicine Farmville North Carolina
United States Carolina East Family Medicine Greenville North Carolina
United States Mark R. Cervi Greenville North Carolina
United States Physicians East, Quadrangle Medical Specialists Greenville North Carolina
United States Eastern Carolina Physicians Kinston North Carolina
United States Natalie A Doyle, MD PA Wilson North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary VLDL apoC-III The effect of treatment with ISIS ApoC-III Rx or Placebo on fasting total apoC-III levels. 92 Days
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