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Clinical Trials/NCT00116519
NCT00116519CompletedPhase 2

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

Eli Lilly and Company54 sites in 1 country300 target enrollmentStarted: July 1, 2005Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
300
Locations
54
Primary Endpoint
Safety after 12 weeks
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Safety after 12 weeks

Effects on HDL-C and Triglycerides after 12 weeks

Secondary Outcomes

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

Investigators

Sponsor Class
Industry

Study Sites (54)

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