Trials / Completed
CompletedNCT01730053
Study of Alirocumab (REGN727/SAR236553) added-on to Rosuvastatin Versus Other Lipid Modifying Treatments (LMT) (ODYSSEY OPTIONS II)
A Randomized, Double-Blind Study of the Efficacy and Safety of REGN727 Added-on to Rosuvastatin Versus Ezetimibe Added-on to Rosuvastatin Versus Rosuvastatin Dose Increase in Patients Who Are Not Controlled on Rosuvastatin
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 305 (actual)
- Sponsor
- Regeneron Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab (REGN727/SAR236553) as an add-on therapy to other LMT in patients with hypercholesterolemia at high cardiovascular (CV) risk.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alirocumab | Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm. |
| DRUG | Rosuvastatin | Rosuvastatin over-encapsulated tablets orally. |
| DRUG | Ezetimibe | Ezetimibe over-encapsulated tablets orally. |
| DRUG | Placebo | Placebo for alirocumab and ezetimibe. |
Timeline
- Start date
- 2012-11-30
- Primary completion
- 2014-04-30
- Completion
- 2014-05-31
- First posted
- 2012-11-21
- Last updated
- 2020-04-07
- Results posted
- 2015-10-28
Locations
93 sites across 9 countries: United States, Australia, Canada, France, Germany, Italy, Mexico, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT01730053. Inclusion in this directory is not an endorsement.