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Clinical trial

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

ID
Name
SLx-4090-08-06
Description
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.
Trial arms
Trial start
2009-01-01
Estimated PCD
2009-09-01
Trial end
2009-09-01
Status
Completed
Phase
Early phase I
Treatment
SLx-4090
tablet
Arms:
1
SLx-4090
tablet
Arms:
2
Placebo
matching tablet
Arms:
3
Statin
Subjects were dosed with the statin prescribed specifically by their prescribing physician.
Arms:
1, 2, 3
Size
133
Primary endpoint
Reduction in LDL-C
12 weeks
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 133, 'type': 'ACTUAL'}}
Updated at
2023-11-18

1 organization

2 products

1 indication

Organization
Response Pharmaceuticals
Product
SLx-4090
Indication
Hyperlipidemia
Product
Statin