A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
NCT ID: NCT02608697
Last Updated: 2017-06-20
Study Results
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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COMPLETED
PHASE2
153 participants
INTERVENTIONAL
2015-10-31
2016-06-30
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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Group 1: CAT-2054 or Placebo Dose 1
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily.
CAT-2054
Placebo
Atorvastatin
Group 2: CAT-2054 or Placebo Dose 2
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo QD and open label 40 mg atorvastatin tablet administered daily.
CAT-2054
Placebo
Atorvastatin
Group 3: CAT-2054 or Placebo Dose 3
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 250 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily.
CAT-2054
Placebo
Atorvastatin
Group 4: CAT-2054 or Placebo Dose 4
A run-in phase with 40 mg atorvastatin tablet administered daily for at least 28 days, followed by a 28-day blinded treatment phase with 400 mg CAT-2054 or placebo BID and open label 40 mg atorvastatin tablet administered daily.
CAT-2054
Placebo
Atorvastatin
Interventions
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CAT-2054
Placebo
Atorvastatin
Eligibility Criteria
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Inclusion Criteria
* Hypercholesterolemia (LDL-C ≥ 70 mg/dL and \< 190 mg/dL) plus a stable dose of statin for at least 4 weeks prior to Screening
* Satisfies one of the following:
1. Female patients of childbearing potential must have used appropriate and highly effective contraception (a regimen which results in a failure rate of \<1% per year) with their partners for 4 weeks prior to Screening, and remain compliant during the treatment phase and until 4 weeks after the last dose of investigational product
2. Male patients must use an acceptable and highly effective contraceptive method during the treatment phase and until 4 weeks after the last dose of investigational product
* Body mass index (BMI) ≤45 kg/m2
Exclusion Criteria
* Type I diabetes mellitus or use of insulin
* Active peptic ulcer disease or a history of muscle disease or myopathy
18 Years
74 Years
ALL
No
Sponsors
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Catabasis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Muscle Shoals, Alabama, United States
Huntington Park, California, United States
Lomita, California, United States
Los Angeles, California, United States
Brooksville, Florida, United States
Hialeah, Florida, United States
Jupiter, Florida, United States
Pembroke Pines, Florida, United States
Winter Park, Florida, United States
Chicago, Illinois, United States
Evanston, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Auburn, Maine, United States
Troy, Michigan, United States
Las Vegas, Nevada, United States
New York, New York, United States
Rochester, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Franklin, Ohio, United States
Lyndhurst, Ohio, United States
Marion, Ohio, United States
Willoughby Hills, Ohio, United States
Mt. Pleasant, South Carolina, United States
Summerville, South Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Orem, Utah, United States
Richmond, Virginia, United States
Olympia, Washington, United States
Countries
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Other Identifiers
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CAT-2054-201
Identifier Type: -
Identifier Source: org_study_id
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