A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
1 other identifier
interventional
153
1 country
34
Brief Summary
The purpose of this placebo-controlled, double-blind study is to assess the effect of several doses of CAT-2054 on LDL-C in hypercholesterolemic patients on a stable dose of high-intensity statin, and to evaluate the safety and tolerability of different doses of CAT-2054 for 4 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2015
Shorter than P25 for phase_2
34 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 20, 2017
June 1, 2017
7 months
November 11, 2015
June 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change in LDL-C from baseline in patients with hypercholesterolemia.
4 weeks
Secondary Outcomes (2)
Frequency of adverse events
8 weeks
Percent change in TG, non-HDL-C, total cholesterol, HDL-C, apoB from baseline in patients with hypercholesterolemia
4 weeks
Study Arms (4)
Group 1: CAT-2054 or Placebo Dose 1
EXPERIMENTALA 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.
Group 2: CAT-2054 or Placebo Dose 2
EXPERIMENTALA 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.
Group 3: CAT-2054 or Placebo Dose 3
EXPERIMENTALA 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.
Group 4: CAT-2054 or Placebo Dose 4
EXPERIMENTALA 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.
Interventions
Eligibility Criteria
You may qualify if:
- Between 18 and 74 years at Screening
- 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:
- 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
- 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
You may not qualify if:
- History of any major cardiovascular event (stroke, TIA, MI, PTCI, CABG, hospitalization due to heart failure) within 6 months of Screening
- Type I diabetes mellitus or use of insulin
- Active peptic ulcer disease or a history of muscle disease or myopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (34)
Unknown Facility
Muscle Shoals, Alabama, 35662, United States
Unknown Facility
Huntington Park, California, 90255, United States
Unknown Facility
Lomita, California, 90717, United States
Unknown Facility
Los Angeles, California, 90057, United States
Unknown Facility
Brooksville, Florida, 34601, United States
Unknown Facility
Hialeah, Florida, 33012, United States
Unknown Facility
Jupiter, Florida, 33458, United States
Unknown Facility
Pembroke Pines, Florida, 33026, United States
Unknown Facility
Winter Park, Florida, 32792, United States
Unknown Facility
Chicago, Illinois, 60607, United States
Unknown Facility
Evanston, Illinois, 60201, United States
Unknown Facility
Indianapolis, Indiana, 46260, United States
Unknown Facility
Kansas City, Kansas, 66160, United States
Unknown Facility
Louisville, Kentucky, 40213, United States
Unknown Facility
Auburn, Maine, 04210, United States
Unknown Facility
Troy, Michigan, 48098, United States
Unknown Facility
Las Vegas, Nevada, 89123, United States
Unknown Facility
New York, New York, 10029, United States
Unknown Facility
Rochester, New York, 14609, United States
Unknown Facility
Cincinnati, Ohio, 45219, United States
Unknown Facility
Cincinnati, Ohio, 45227, United States
Unknown Facility
Cincinnati, Ohio, 45246, United States
Unknown Facility
Columbus, Ohio, 43213, United States
Unknown Facility
Franklin, Ohio, 45005, United States
Unknown Facility
Lyndhurst, Ohio, 44124, United States
Unknown Facility
Marion, Ohio, 43302, United States
Unknown Facility
Willoughby Hills, Ohio, 44094, United States
Unknown Facility
Mt. Pleasant, South Carolina, 29464, United States
Unknown Facility
Summerville, South Carolina, 29485, United States
Unknown Facility
Houston, Texas, 77036, United States
Unknown Facility
Houston, Texas, 77074, United States
Unknown Facility
Orem, Utah, 84058, United States
Unknown Facility
Richmond, Virginia, 23294, United States
Unknown Facility
Olympia, Washington, 98502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
November 20, 2015
Study Start
October 1, 2015
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
June 20, 2017
Record last verified: 2017-06