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OpenTrials
Completed

NCT Number: NCT00116519

A Study in People With Abnormal Fat Levels in the Blood

The purposes of this study are to determine:

* The safety of the study medication and any side effects that might be associated with it; * Whether the study medication can help patients with low levels of 'good' cholesterol (HDL-C) and high blood fats or triglycerides (TG); * How much of the study medication should be given to patients; * How the study medication compares to fenofibrate (Lofibra), a drug used for people with low levels of HDL-C and high levels of TG.

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Key information

Conditions

Dyslipidemia Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. test, Hoover, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women between 18 and 80 years of age
  • People with abnormal fat levels in the blood (low HDL, high TG)

Exclusion criteria

  • People with diabetes
  • People whose blood pressure is greater than 160/95 mm Hg, on or off blood pressure medicine
  • People who have had frequent chest pain or unstable angina, a heart attack or a heart procedure, including stent placement, within the past 3 months

Treatment and study plan

PPAR alpha

Drug

Placebo

Drug

Primary outcomes

  1. Effects on HDL-C and Triglycerides after 12 weeks

  2. Safety after 12 weeks

Secondary outcomes

  1. Effects on LDL-C after 12 weeks

  2. Effects on biomarkers of atherosclerosis after 12 weeks

  3. Effects on factors of metabolic syndrome after 12 weeks

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly

Important dates

Study start
2005
Study completion
2006
First posted
Jun 30, 2005
Registry last updated
Jan 26, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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