A Study in People With Abnormal Fat Levels in the Blood

This study has been completed.

First Received on June 29, 2005. Last Updated on 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 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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 ClinicalTrials.gov Identifier (NCT Number):

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.

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

Additional relevant MeSH terms:

Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 24, 2012