Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of Different Doses of SLx-4090 in Combination With a Statin vs. Statin Mono-therapy in Patients With Hyperlipidemia
1 other identifier
interventional
133
1 country
19
Brief Summary
The purpose of this study is to determine whether SLx-4090 in combination with statin therapy will reduce LDL-C in patients with hyperlipidemia more effectively than statin therapy alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2009
Shorter than P25 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2008
CompletedFirst Posted
Study publicly available on registry
December 18, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedNovember 18, 2023
April 1, 2023
8 months
December 17, 2008
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in LDL-C
12 weeks
Secondary Outcomes (1)
Adverse events
12 weeks
Study Arms (3)
1
EXPERIMENTALSLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
2
EXPERIMENTALSLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
3
OTHERPlacebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Interventions
Eligibility Criteria
You may qualify if:
- LDL-C \> or = 100 mg/dL
- On stable statin therapy for at least 6 weeks
You may not qualify if:
- Coronary heart disease or risk factors for CHD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Birmingham, Alabama, 35209, United States
Unknown Facility
Tempe, Arizona, 85282, United States
Unknown Facility
Tucson, Arizona, 85710, United States
Unknown Facility
Jacksonville, Florida, 32205, United States
Unknown Facility
Atlanta, Georgia, 30342, United States
Unknown Facility
Addison, Illinois, 60101, United States
Unknown Facility
Chicago, Illinois, 60611, United States
Unknown Facility
Chicago, Illinois, 60654, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Louisville, Kentucky, 40213, United States
Unknown Facility
Edina, Minnesota, 55435, United States
Unknown Facility
St Louis, Missouri, 63141, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Raleigh, North Carolina, 27609, United States
Unknown Facility
Cincinnati, Ohio, 45212, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cleveland, Ohio, 44122, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2008
First Posted
December 18, 2008
Study Start
January 1, 2009
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
November 18, 2023
Record last verified: 2023-04