The Efficacy and Safety of PRC-4016 in Hypertriglyceridemic Subjects

P

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

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

Trial contacts and locations

39

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Data sourced from clinicaltrials.gov

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