Trial record 1 of 1 for:
dfi11566
Efficacy and Safety Evaluation of Alirocumab (SAR236553/REGN727) When Co-administered With High Dose of Atorvastatin in Patients With Primary Hypercholesterolemia
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| ClinicalTrials.gov Identifier: NCT01288469 |
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Recruitment Status :
Completed
First Posted : February 2, 2011
Results First Posted : September 24, 2015
Last Update Posted : September 24, 2015
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Sponsor:
Sanofi
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Sanofi
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Brief Summary:
Primary Objective:
To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg.
Secondary Objectives:
- To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.
- To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg.
- To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin.
- To evaluate the development of anti-alirocumab antibodies.
- To evaluate the pharmacokinetics of alirocumab.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hypercholesterolemia | Drug: Alirocumab Drug: Placebo (for alirocumab) Drug: Atorvastatin Drug: Placebo (for atorvastatin) | Phase 2 |
The duration of study participation depended on the status of the patient at screening:
- For participants receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening, the study participation was to be approximately 17 weeks including a screening period of 1 week, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.
- For participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants, the study participation was to be approximately 23 weeks with a screening period of 1 week, a run-in treatment period with atorvastatin 10 mg of 6 weeks, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 92 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed Dose/Dose Regimen, Multicenter Study Evaluating the Efficacy and Safety of SAR236553 When Co-administered With 80 mg of Atorvastatin Over 8 Weeks in Patients With Primary Hypercholesterolemia and LDL-cholesterol ≥ 100 mg/dL (≥2.59 mmol/L) on Atorvastatin 10 mg |
| Study Start Date : | January 2011 |
| Actual Primary Completion Date : | September 2011 |
| Actual Study Completion Date : | September 2011 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo + Atorvastatin 80 mg
Placebo (for alirocumab) subcutaneous (SC) administration every 2 weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
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Drug: Placebo (for alirocumab)
One SC injection in the abdomen only. Drug: Atorvastatin Over-encapsulated tablet orally once daily in the evening with dinner. |
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Experimental: Alirocumab + Atorvastatin 10 mg
Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
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Drug: Alirocumab
One subcutaneous (SC) injection in the abdomen only.
Other Names:
Drug: Atorvastatin Over-encapsulated tablet orally once daily in the evening with dinner. Drug: Placebo (for atorvastatin) One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner. |
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Experimental: Alirocumab + Atorvastatin 80 mg
Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
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Drug: Alirocumab
One subcutaneous (SC) injection in the abdomen only.
Other Names:
Drug: Atorvastatin Over-encapsulated tablet orally once daily in the evening with dinner. |
Primary Outcome Measures :
- Percent Change From Baseline in Calculated LDL-C at Week 8 - On-treatment Analysis [ Time Frame: From Baseline to Week 8 (LOCF) ]Calculated LDL-C values were obtained using the Friedewald formula. Baseline adjusted least squares (LS) means and standard errors were estimated using an analysis of covariance (ANCOVA) model including available post-baseline data on treatment from first investigational product (IP) injection up to 21 days after last IP injection (on-treatment analysis). Missing Week 8 data were imputed by last observation carried forward [LOCF] method.
Secondary Outcome Measures :
- Absolute Change From Baseline in Calculated LDL-C (mmol/L) at Week 8 - On-treatment Analysis [ Time Frame: From baseline to Week 8 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
- Absolute Change From Baseline in Calculated LDL-C (mg/dL) at Week 8 - On-treatment Analysis [ Time Frame: From baseline to Week 8 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
- Percentage of Participants Achieving Calculated LDL-C <100 mg/dL (2.59 mmol/L) and < 70 mg/dL (1.81 mmol/L) at Week 8 - On-treatment Analysis [ Time Frame: Week 8 (LOCF) ]
- Percent Change From Baseline in Total Cholesterol, Fasting Triglycerides, Non-high-Density Lipoprotein Cholesterol (Non-HDL-C), Apolipoprotein B (Apo-B) and Lipoprotein(a) at Week 8 - On-treatment Analysis [ Time Frame: From baseline to Week 8 (LOCF) ]Since the assumptions of normal distribution and equality of variances were not verified for the lipid parameters, percent changes were expressed as median (interquartile range).
- Percent Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C) at Week 8 - On-treatment Analysis [ Time Frame: From Baseline to Week 8 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA model as for primary endpoint.
- Absolute Change in the Ratio Apolipoprotein B/Apolipoprotein A-1 (ApoB/ApoA-1) From Baseline to Week 8 - On-treatment Analysis [ Time Frame: From Baseline to Week 8 (LOCF) ]Adjusted LS means and standard errors were estimated using the same ANCOVA as for primary endpoint.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Participants receiving a lipid-lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants with primary hypercholesterolemia if they are likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the end of the 6-week run-in treatment period on atorvastatin therapy
OR
- Participants with primary hypercholesterolemia treated with stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening and likely to have low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥ 2.59 mmol/L) at the screening visit.
Exclusion criteria:
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LDL-C < 100 mg/dL (< 2.59 mmol/L) at Week -1 (V1):
- After the run-in period on atorvastatin 10 mg for participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to the screening period, or drug naive participants.
OR
- At the first visit for participants who are being treated with atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening visit.
- Participants not previously instructed on a cholesterol-lowering diet.
- Participants with type 1 diabetes.
- Participants with type 2 diabetes treated with insulin.
- Participants with type 2 diabetes and with an HbA1c ≥ 8.5% at screening visit (considered poorly controlled).
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Laboratory findings measured before randomization:
- Triglycerides (TG) > 350 mg/dL (> 3.95 mmol/L) at screening visit.
- Positive serum or urine pregnancy test in females of childbearing potential.
- Pregnant or breast-feeding women.
- Women of childbearing potential with no effective contraceptive method.
The above information is not intended to contain all considerations relevant to a Participant's potential participation in a clinical trial.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01288469
Locations
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Sponsors and Collaborators
Sanofi
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01288469 |
| Other Study ID Numbers: |
DFI11566 U1111-1117-9994 ( Other Identifier: UTN ) |
| First Posted: | February 2, 2011 Key Record Dates |
| Results First Posted: | September 24, 2015 |
| Last Update Posted: | September 24, 2015 |
| Last Verified: | January 2015 |
Keywords provided by Sanofi:
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10020603 |
Additional relevant MeSH terms:
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Hypercholesterolemia Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Atorvastatin Antibodies, Monoclonal Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors Immunologic Factors Physiological Effects of Drugs |