A Study in People With Abnormal Fat Levels in the Blood

This study has been completed.

First Received: June 29, 2005 Last Updated: January 24, 2007 History of Changes

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00116519

Purpose

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.

Condition	Intervention	Phase
Dyslipidemia	Drug: PPAR alpha Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	PPAR Alpha: A Phase 2 Dose-Finding and Safety Study for Atherogenic Dyslipidemia by Eli Lilly

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Effects on HDL-C and Triglycerides after 12 weeks
Safety after 12 weeks

Secondary Outcome Measures:

Effects on LDL-C after 12 weeks
Effects on biomarkers of atherosclerosis after 12 weeks
Effects on factors of metabolic syndrome after 12 weeks

Estimated Enrollment:	300
Study Start Date:	July 2005
Estimated Study Completion Date:	October 2006

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116519

Show 54 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday - Friday 9am-5pm Eastern time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Nissen SE, Nicholls SJ, Wolski K, Howey DC, McErlean E, Wang MD, Gomez EV, Russo JM. Effects of a potent and selective PPAR-alpha agonist in patients with atherogenic dyslipidemia or hypercholesterolemia: two randomized controlled trials. JAMA. 2007 Mar 28;297(12):1362-73. Epub 2007 Mar 25.

Study ID Numbers:	5750, H8D-MC-EMBB
Study First Received:	June 29, 2005
Last Updated:	January 24, 2007
ClinicalTrials.gov Identifier:	NCT00116519 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010