A Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
Status: | Active, not recruiting |
---|---|
Conditions: | High Cholesterol |
Therapuetic Areas: | Cardiology / Vascular Diseases |
Healthy: | No |
Age Range: | 18 - 74 |
Updated: | 4/21/2016 |
Start Date: | October 2015 |
End Date: | June 2016 |
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of CAT-2054 in Combination With Atorvastatin in Patients With Hypercholesterolemia
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.
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.
Inclusion Criteria:
- 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:
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:
- 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
We found this trial at
34
sites
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