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

Response Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia

Treatments: Other: Placebo; Drug: Statin; Drug: SLx-4090

Study type: Interventional

Funder types: Industry

Identifiers

NCT00810979

SLx-4090-08-06

Details and patient eligibility

About

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.

Full description

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

Enrollment: 133 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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133 participants in 3 patient groups

1

Experimental group

Description:

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

Treatment:

Drug: Statin

Drug: SLx-4090

Drug: SLx-4090

2

Experimental group

Description:

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

Treatment:

Drug: Statin

Drug: SLx-4090

Drug: SLx-4090

3

Other group

Description:

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

Treatment:

Other: Placebo

Drug: Statin