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

Response Pharmaceuticals133 enrolled

Overview

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.

1. LDL-C after 12 weeks of treatment 2. Safety and tolerability 3. Plasma levels of SLx-4090

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

133

Conditions

Hyperlipidemia

Interventions

SLx-4090DRUG

tablet

SLx-4090DRUG

tablet

PlaceboOTHER

matching tablet

StatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (19)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Tempe, Arizona, United States

Unnamed facility

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Reduction in LDL-C

Time frame: 12 weeks

Secondary Outcomes

Adverse events

Time frame: 12 weeks

Data from ClinicalTrials.gov

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