EUCTR2012-002344-24-ES
Active, not recruiting
Phase 1
A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Atorvastatin versus Ezetimibe Added-on to Atorvastatin versus Atorvastatin Dose Increase versus Switch to Rosuvastatin in Patients Who are Not Controlled on Atorvastatin - Odyssey Options I
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Regeneron Pharmaceuticals, Inc.
- Enrollment
- 355
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. A patient must meet either 1a or 1b to be eligible for inclusion in the study:
- •a. Patients with screening (visit 1\) LDL\-C ?70 mg/dL (1\.81 mmol/L) who are not adequately controlled with a 20 mg or 40 mg stable daily dose of atorvastatin for at least 4 weeks before the screening visit (visit 1\), with or without other LMT (excluding EZE). Patients with heFH\* or non\-FH must also have a history of documented CHD (defined below), or non\-CHD CVD (defined below), or diabetes mellitus with target organ damage.
- •b. Patients with screening (visit 1\) LDL\-C ?100 mg/dL (2\.59 mmol/L) who are not adequately controlled with a 20 mg or 40 mg daily dose of atorvastatin for at least 4 weeks before the screening visit (visit 1\), with or without other LMT (excluding EZE). Patients must also have heFH\*, or have non\-FH, without CHD or non\-CHD CVD, but with a calculated 10\-year fatal CVD risk SCORE ?5%, or with moderate CKD, or with diabetes mellitus but no target organ damage.
- •Note: Details for the inclusion criteria are provided below.
- •2\. Provide signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 350
- •F.1\.3 Elderly (\>\=65 years) yes
Exclusion Criteria
- •LDL\-C \<70 mg/dL (\<1\.81 mmol/L) in patients with CVD
- •LDL\-C \<100 mg/dL (\<2\.59 mmol/L) in patients without CVD, but with other risk factors
- •LDL\-C \>250 mg/dL or TG \>400 mg/dL
- •Homozygous FH or patients receiving plasmapheresis
- •CV event within 3 months prior to screening
- •NYHA Class III or IV heart failure
- •History of hemorrhagic stroke
- •Uncontrolled endocrine disease known to influence serum lipids
- •Any clinically significant abnormality that in the judgment of the investigator would preclude safe completion of the study or constrain endpoints assessment such as major systemic diseases, patients with short life expectancy, patients who cannottolerate subcutaneous injections.
- •Use of ezetimibe or red yeast rice products within 4 weeks of screening
Outcomes
Primary Outcomes
Not specified
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