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

Phase 2

Completed

• Conditions: Hyperlipidemia
• Interventions: Drug: SLx-4090; Other: Placebo; Drug: Statin

• Registration Number: NCT00810979
• Lead Sponsor: Response Pharmaceuticals

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

1. LDL-C after 12 weeks of treatment

2. Safety and tolerability

3. Plasma levels of SLx-4090

Study Timeline

• Study First Submitted: 2008-12-17
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Study Start: 2009-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Disposition First Submitted: 2014-12-09
• Disposition First Submitted QC: 2014-12-10
• Disposition First Posted: 2014-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	SLx-4090	SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
1	Statin	SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
1	SLx-4090	SLx-4090 dose #1 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
2	Statin	SLx-4090 dose #2 in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
3	Placebo	Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.
3	Statin	Placebo in combination with statin drug. Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Primary Outcome Measures

Name	Time	Method
Reduction in LDL-C	12 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events	12 weeks