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

NCT ID: NCT00810979

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-09-30

Brief Summary

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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

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

Conditions

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Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

SLx-4090

Intervention Type DRUG

tablet

Statin

Intervention Type DRUG

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

2

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

Group Type EXPERIMENTAL

SLx-4090

Intervention Type DRUG

tablet

Statin

Intervention Type DRUG

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

3

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

Group Type OTHER

Placebo

Intervention Type OTHER

matching tablet

Statin

Intervention Type DRUG

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

Interventions

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SLx-4090

tablet

Intervention Type DRUG

SLx-4090

tablet

Intervention Type DRUG

Placebo

matching tablet

Intervention Type OTHER

Statin

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Response Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Birmingham, Alabama, United States

Site Status

Tempe, Arizona, United States

Site Status

Tucson, Arizona, United States

Site Status

Jacksonville, Florida, United States

Site Status

Atlanta, Georgia, United States

Site Status

Addison, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Chicago, Illinois, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Louisville, Kentucky, United States

Site Status

Edina, Minnesota, United States

Site Status

St Louis, Missouri, United States

Site Status

Rochester, New York, United States

Site Status

Raleigh, North Carolina, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cincinnati, Ohio, United States

Site Status

Cleveland, Ohio, United States

Site Status

Mt. Pleasant, South Carolina, United States

Site Status

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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SLx-4090-08-06

Identifier Type: -

Identifier Source: org_study_id

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