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NCT00810979 Clinical Trial

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

Hyperlipidemia Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00810979
Other study ID # SLx-4090-08-06
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date January 2009
Est. completion date September 2009

Study information
Verified date April 2023
Source Response Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 133
Est. completion date September 2009
Est. primary completion date September 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• SLx-4090
tablet
• SLx-4090
tablet
Other:
• Placebo
matching tablet
Drug:
• Statin
Subjects were dosed with the statin prescribed specifically by their prescribing physician.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Response Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in LDL-C 12 weeks
Secondary Adverse events 12 weeks
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