The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

Pronova

Status and phase: Completed; Phase 2

Conditions: Dyslipidemia

Treatments: Drug: PRC-4016; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01893515

CTN 4016 13201

Details and patient eligibility

About

The objectives of this study is

• To evaluate the efficacy of PRC-4016 by assessment of the percentage change in blood lipids and lipoprotein parameters from baseline after 12 weeks of treatment.
• To evaluate the safety of PRC-4016 as assessed by adverse events and other safety parameters

Full description

6-8 weeks screening period with diet/lifestyle stabilization and lipid qualification

Enrollment: 87 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Fasting triglycerides 500-1500 mg/dl
• Not on other lipid altering therapy, OR on stable lipid altering therapy

Main Exclusion Criteria:

• Type I diabetes or uncontrolled type II diabetes
• Recent cardiovascular or coronary event
• History of pancreatitis
• History or evidence of major and clinically significant diseases that would interfere with the conduct of the study or interpretation of data
• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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87 participants in 2 patient groups, including a placebo group

PRC-4016

Experimental group

Description:

PRC-4016, oral administration once daily, capsule

Treatment:

Drug: PRC-4016

Placebo

Placebo Comparator group

Description:

Placebo, oral administration once daily, capsule

Treatment:

Drug: Placebo