Back to resultsComparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
Primary Purpose
Hyperlipidemia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SLx-4090
SLx-4090
Placebo
Statin
Sponsored by
About this trial
This is an interventional treatment trial for Hyperlipidemia
Eligibility Criteria
Inclusion Criteria:
- LDL-C > or = 100 mg/dL
- On stable statin therapy for at least 6 weeks
Exclusion Criteria:
- Coronary heart disease or risk factors for CHD
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
1
2
3
Arm Description
SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Outcomes
Primary Outcome Measures
Reduction in LDL-C
Secondary Outcome Measures
Adverse events
Full Information
NCT ID
NCT00810979
First Posted
December 17, 2008
Last Updated
January 16, 2015
Sponsor
Kadmon Corporation, LLC
1. Study Identification
Unique Protocol Identification Number
NCT00810979
Brief Title
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kadmon Corporation, LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
LDL-C after 12 weeks of treatment
Safety and tolerability
Plasma levels of SLx-4090
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Arm Title
2
Arm Type
Experimental
Arm Description
SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Arm Title
3
Arm Type
Other
Arm Description
Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Intervention Type
Drug
Intervention Name(s)
SLx-4090
Intervention Description
tablet
Intervention Type
Drug
Intervention Name(s)
SLx-4090
Intervention Description
tablet
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
matching tablet
Intervention Type
Drug
Intervention Name(s)
Statin
Intervention Description
Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Primary Outcome Measure Information:
Title
Reduction in LDL-C
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adverse events
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
LDL-C > or = 100 mg/dL
On stable statin therapy for at least 6 weeks
Exclusion Criteria:
Coronary heart disease or risk factors for CHD
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia
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