Status:
UNKNOWN
Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia
Lead Sponsor:
Trygg Pharma, Inc.
Conditions:
Severe Hypertriglyceridemia
Eligibility:
All Genders
18-79 years
Phase:
PHASE3
Brief Summary
The primary objective is to determine the efficacy of AKR963 compared to placebo and active comparator in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ ...
Detailed Description
Increases in triglyceride concentrations have been correlated with increased risk for pancreatitis as well as for coronary heart disease (Ginsberg 2001, 2002). The incidence rates for major coronary e...
Eligibility Criteria
Inclusion
- Men and women, ages 18-79
- Fasting triglyceride ≥500 mg/dL and ≤1500 mg/dL
- Provide written informed consent and authorization for protected health information disclosure
Exclusion
- Women who are pregnant or lactating, or planning to become pregnant
- Use of non-statin lipid-altering drugs which cannot be stopped or other supplements with potential lipid-altering effects
- History of pancreatitis
- History of bariatric surgery or currently on weight loss drugs or in weight loss programs
- Treatment with any agent that may affect lipid levels or hepatic function
- Consumption of more than 3 alcoholic beverages per day
- History of cancer within last 2 years
- Participation in another clinical trial involving an investigational agent in the last 30 days
- Other parameters will be assessed at the study center to ensure eligibility for this study
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2012
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT01229566
Start Date
October 1 2010
End Date
July 1 2012
Last Update
November 24 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Illinois Recruiting
Chicago, Illinois, United States, 60101