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Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

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ClinicalTrials.gov Identifier: NCT01229566
Recruitment Status : Unknown
Verified November 2010 by Trygg Pharma, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 27, 2010
Last Update Posted : November 24, 2011
Sponsor:
Information provided by (Responsible Party):
Trygg Pharma, Inc.

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 ≥ 500 and ≤ 1500 mg/dL.

Condition or disease Intervention/treatment Phase
Severe Hypertriglyceridemia Drug: AKR-963 Phase 3

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 events in the Munster Heart Study increased from 4.4% among Subjects with baseline TG concentrations under 200 mg/dL to 9.3% among Subjects with TG concentrations in the 200-399 mg/dL range, and up to 13.2% in Subjects with TG levels ranging from 400-799 mg/dL (Assmann 1996).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase III Study to Assess Efficacy and Safety of AKR-963 Therapy in Subjects With Severe Hypertriglyceridemia
Study Start Date : October 2010
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Active Comparator
Active comparator
Drug: AKR-963
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Placebo Comparator: Placebo
Placebo control
Drug: AKR-963
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
Experimental: AKR-963
Investigational drug
Drug: AKR-963
3600mg/day in capsules of AKR-963, Placebo, or Active Comparator



Primary Outcome Measures :
  1. Difference between AKR963 and Control [placebo or active control] treatment groups in triglyceride lowering effect [ Time Frame: 12 weeks ] [ Time Frame: 12 weeks ]
    The percent change in TG levels from baseline (average of Weeks -2, -1, and 0) to the end of Period A, first 12-week double-blind treatment, (average of Weeks 11 and 12).



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01229566


Locations
United States, Illinois
Illinois Recruiting
Chicago, Illinois, United States, 60101
Sponsors and Collaborators
Trygg Pharma, Inc.
Investigators
Principal Investigator: Kevin C Maki, PhD Addison, Illinois Recruiting

Responsible Party: Trygg Pharma, Inc.
ClinicalTrials.gov Identifier: NCT01229566     History of Changes
Other Study ID Numbers: TRGG-963-002
First Posted: October 27, 2010    Key Record Dates
Last Update Posted: November 24, 2011
Last Verified: November 2010

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases