Trial record 1 of 1 for:
LPS14245
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02476006 |
Recruitment Status :
Completed
First Posted : June 19, 2015
Results First Posted : March 30, 2020
Last Update Posted : March 28, 2022
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Hypercholesterolemia |
Interventions |
Drug: ALIROCUMAB SAR236553 (REGN727) Drug: placebo (for injection training only) Drug: ezetimibe Drug: atorvastatin Drug: rosuvastatin Drug: simvastatin |
Enrollment | 998 |
Participant Flow
Recruitment Details | The study was conducted at 156 sites in 17 countries. A total of 1305 participants were screened between 23-June-2015 to 27-December 2016, of whom 307 were screen failures. Screen failures were mainly due to exclusion criteria met. |
Pre-assignment Details | A total of 998 participants were enrolled in the study. |
Arm/Group Title | Alirocumab |
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Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (Q2W) or 75 mg SC Q2W added to stable lipid modifying therapies (LMT) up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response. |
Period Title: Overall Study | |
Started | 998 |
Treated | 994 |
Completed | 878 |
Not Completed | 120 |
Reason Not Completed | |
Death | 4 |
Lack of treatment efficacy | 2 |
Pregnancy | 1 |
Participant did not wish to continue | 39 |
Adverse Event | 41 |
Poor compliance to study protocol | 3 |
Sponsor decision | 6 |
Lost to Follow-up | 5 |
Physician Decision | 5 |
Study ended treatment not available | 4 |
Switched to commercial drug | 4 |
Excluded from study | 1 |
Protocol Violation | 1 |
Enrolled but not treated | 4 |
Baseline Characteristics
Arm/Group Title | Alirocumab | |
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Participants received Alirocumab 150 mg SC Q2W or 75 mg SC Q2W added to stable LMT up to a maximum of 120 weeks. Alirocumab dose was either up-titrated from 75 to 150 mg Q2W or down-titrated from 150 to 75 mg Q2W, based on Investigator judgment and treatment response. | |
Overall Number of Baseline Participants | 994 | |
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Analysis was performed on safety population that included all participants who had signed the informed consent form (ICF) and who had received at least one dose or partial dose of alirocumab.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 994 participants | |
56.6 (11.7) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 994 participants | |
Female |
369 37.1%
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Male |
625 62.9%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 994 participants | |
White/Caucasian |
969 97.5%
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Black |
10 1.0%
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Asian/Oriental |
6 0.6%
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Multiracial |
1 0.1%
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Other |
8 0.8%
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
The Sponsor supports publication of clinical trial results but may request that investigators temporarily delay or alter publications in order to protect proprietary information. The Sponsor may also require that the results of multicenter studies be published only in their entirety and not as individual site data.
Results Point of Contact
Name/Title: | Trial Transparency Team |
Organization: | Sanofi aventis recherche & développement |
Phone: | 800-633-1610 ext 1# |
EMail: | Contact-US@sanofi.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT02476006 |
Other Study ID Numbers: |
LPS14245 2015-000620-28 ( EudraCT Number ) U1111-1163-0984 ( Other Identifier: UTN ) |
First Submitted: | June 16, 2015 |
First Posted: | June 19, 2015 |
Results First Submitted: | March 13, 2020 |
Results First Posted: | March 30, 2020 |
Last Update Posted: | March 28, 2022 |