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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810979

Enrollment

133

Registered

2008-12-18

Start date

2009-01-31

Completion date

2009-09-30

Last updated

2023-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia

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

Interventions

DRUGSLx-4090

tablet

OTHERPlacebo

matching tablet

DRUGStatin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Reduction in LDL-C	12 weeks

Secondary

Measure	Time frame
Adverse events	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026