Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients on Stable Statin Therapy
NCT ID: NCT02571257
Last Updated: 2020-04-09
Study Results
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Basic Information
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COMPLETED
PHASE2
66 participants
INTERVENTIONAL
2000-08-31
2002-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo treatment on stable background statin therapy
Placebo
Gemcabene 300 mg QD
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Gemcabene
1-300 mg tablet, QD, 56 days
Gemcabene 900 mg QD
Gemcabene (also known as CI-1027) treatment on stable background statin therapy
Gemcabene
3-300 mg tablets, QD, 56 days
Interventions
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Gemcabene
1-300 mg tablet, QD, 56 days
Gemcabene
3-300 mg tablets, QD, 56 days
Placebo
Eligibility Criteria
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Inclusion Criteria
* 18 to 65 years of age
* Baseline LDL-C ≥ 130 mg/dL (3.4 mmol/L)
Exclusion Criteria
* Triglycerides (TG) \>400 mg/dL
* Creatine phosphokinase (CPK) \>3 × the upper limit of normal (ULN)
* Body Mass Index (BMI) \>35 kg/m2
* Uncontrolled diabetes mellitus (HbA1c \>10%)
* Renal dysfunction (blood urea nitrogen \[BUN\] or creatinine \>2 × ULN)
* Hepatic dysfunction (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>2 × ULN)
* Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous month
18 Years
65 Years
ALL
No
Sponsors
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NeuroBo Pharmaceuticals Inc.
INDUSTRY
Responsible Party
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References
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Stein E, Bays H, Koren M, Bakker-Arkema R, Bisgaier C. Efficacy and safety of gemcabene as add-on to stable statin therapy in hypercholesterolemic patients. J Clin Lipidol. 2016 Sep-Oct;10(5):1212-22. doi: 10.1016/j.jacl.2016.08.002. Epub 2016 Aug 10.
Other Identifiers
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1027-018
Identifier Type: -
Identifier Source: org_study_id
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