Comparison of SLx-4090 Combined With Statin Therapy Versus Statin Alone in Reducing LDL-C in Patients With Hyperlipidemia

Sponsor

Kadmon Corporation, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT00810979

Collaborator

(none)

133

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperlipidemia	Drug: SLx-4090 Drug: SLx-4090 Other: Placebo Drug: Statin	Phase 2

Detailed Description

LDL-C after 12 weeks of treatment
Safety and tolerability
Plasma levels of SLx-4090

Study Design

Study Type:

Interventional

Actual Enrollment :

133 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Sep 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.	Drug: SLx-4090 tablet Drug: Statin Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Experimental: 2 SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.	Drug: SLx-4090 tablet Drug: Statin Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Other: 3 Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.	Other: Placebo matching tablet Drug: Statin Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Arm

Intervention/Treatment

Experimental: 1

SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Drug: SLx-4090

tablet

Drug: Statin

Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Experimental: 2

SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Drug: SLx-4090

tablet

Drug: Statin

Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Other: 3

Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Other: Placebo

matching tablet

Drug: Statin

Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Outcome Measures

Primary Outcome Measures

Reduction in LDL-C [12 weeks]

Secondary Outcome Measures

Adverse events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	State	Country	Postal Code
1	Birmingham	Alabama	United States	35209
2	Tempe	Arizona	United States	85282
3	Tuscon	Arizona	United States	85710
4	Jacksonville	Florida	United States	32205
5	Atlanta	Georgia	United States	30342
6	Addison	Illinois	United States	60101
7	Chicago	Illinois	United States	60611
8	Chicago	Illinois	United States	60654
9	Indianapolis	Indiana	United States	46260
10	Louisville	Kentucky	United States	40213
11	Edina	Minnesota	United States	55435
12	St. Louis	Missouri	United States	63141
13	Rochester	New York	United States	14609
14	Raleigh	North Carolina	United States	27609
15	Cincinnati	Ohio	United States	45212
16	Cincinnati	Ohio	United States	45219
17	Cleveland	Ohio	United States	44122
18	Mt. Pleasant	South Carolina	United States	29464
19	Richmond	Virginia	United States	23294

Sponsors and Collaborators

Kadmon Corporation, LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kadmon Corporation, LLC

ClinicalTrials.gov Identifier:

NCT00810979

Other Study ID Numbers:

SLx-4090-08-06

First Posted:

Dec 18, 2008

Last Update Posted:

Jan 28, 2015

Last Verified:

Jan 1, 2015

Additional relevant MeSH terms:

Hyperlipidemias

Hyperlipoproteinemias

Study Results

No Results Posted as of Jan 28, 2015