Long-term Safety and Tolerability of SAR236553 (REGN727) Versus Placebo on Top of Lipid-Modifying Therapy in High Cardiovascular Risk Patients With Hypercholesterolemia (ODYSSEY Long Term)
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Purpose
Primary Objective:
To evaluate the long-term safety and tolerability of SAR236553 (REGN727) in high cardiovascular risk patients with hypercholesterolemia not adequately controlled with their current lipid modifying therapy (LMT)
Secondary Objectives:
- To evaluate the effect of SAR236553 (REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 24 weeks of treatment in comparison with placebo
- To evaluate the effect of SAR236553 (REGN727) in comparison with placebo on LDL-C at other time points
- To evaluate the effects of SAR236553 (REGN727) on other lipid parameters
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia |
Other: placebo Drug: SAR236553 (REGN727) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Long-term Safety and Tolerability of SAR236553 (REGN727) in High Cardiovascular Risk Patients With Hypercholesterolemia Not Adequately Controlled With Their Lipid Modifying Therapy: A Randomized, Double-Blind, Placebo-Controlled Study |
- Assessment of safety parameters (adverse events, laboratory data, vital signs, and ECG) [ Time Frame: Up to 20 months ] [ Designated as safety issue: Yes ]
- Percent change in calculated low density lipoprotein cholesterol (LDL-C) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
- Percent change in calculated LDL-C [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
- Percent change in other lipid parameters [ Time Frame: From baseline up to week 78 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 2100 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SAR236553 (REGN727)
Injection through subcutaneous (SC) administration. Background statin therapy or other lipid modifying therapy will be administered according to site investigator discretion as background therapy.
|
Drug: SAR236553 (REGN727)
SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9) Pharmaceutical form:solution for injection Route of administration: subcutaneous |
|
Placebo Comparator: Placebo
Injection through subcutaneous (SC) administration. Background statin therapy or other lipid modifying therapy will be administered according to site investigator discretion as background therapy.
|
Other: placebo
Pharmaceutical form:solution for injection Route of administration: subcutaneous
|
Detailed Description:
The maximum study duration will be 88 weeks per patient, including a 78-week randomized treatment period.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria: Either A or B below and who are not adequately controlled with their lipid-modifying therapy: A) Patients with heterozygous familial hypercholesterolemia (heFH) with or without established coronary heart disease (CHD) or CHD risk equivalents OR B) Patients with hypercholesterolemia together with established CHD or CHD risk equivalents. Exclusion criteria: -Age < 18 years -LDL-C <70 mg/dL (< 1.81 mmol/L) -Fasting serum triglycerides > 400 mg/dL (>4.52 mmol/L) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Contacts and Locations
Show 357 Study Locations| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01507831 History of Changes |
| Other Study ID Numbers: | LTS11717, 2011-002806-59, U1111-1121-3928 |
| Study First Received: | January 6, 2012 |
| Last Updated: | May 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013