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Efficacy Study to Treat Subjects With Severe Hypertriglyceridemia

NCT ID: NCT01229566

Last Updated: 2011-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Severe Hypertriglyceridemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active Comparator

Active comparator

Group Type ACTIVE_COMPARATOR

AKR-963

Intervention Type DRUG

3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Placebo

Placebo control

Group Type PLACEBO_COMPARATOR

AKR-963

Intervention Type DRUG

3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

AKR-963

Investigational drug

Group Type EXPERIMENTAL

AKR-963

Intervention Type DRUG

3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Interventions

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AKR-963

3600mg/day in capsules of AKR-963, Placebo, or Active Comparator

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Trygg Pharma, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin C Maki, PhD

Role: PRINCIPAL_INVESTIGATOR

Addison, Illinois Recruiting

Locations

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Illinois Recruiting

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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TRGG-963-002

Identifier Type: -

Identifier Source: org_study_id