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A Study in People With Abnormal Fat Levels in the Blood

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00116519
First received: June 29, 2005
Last updated: January 24, 2007
Last verified: January 2007
History of Changes
  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):

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 16, 2013