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Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Primary Purpose

Hypercholesterolemia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ALIROCUMAB SAR236553 (REGN727)

placebo (for injection training only)

ezetimibe

atorvastatin

rosuvastatin

simvastatin

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Either A, B, C, D, or E below and not adequately controlled with a maximally tolerated dose of statin with or without other LMTs, all at stable doses for at least 4 weeks prior to the screening visit (Week-3):

A. Participants suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations greater than or equal to (>=)160 mg/dL (4.14 millimoles per liter [mmol/L]) despite treatment.

B. Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and two or more CV risk factors among this list:

LDL-C greater than (>) 250 milligrams per deciliter (mg/dL) (6.46 mmol/L) at the time of the familial hypercholesterolemia (FH) diagnosis (before treatment).
Family history of premature-onset coronary heart disease (CHD; first-degree male relative with onset before age 55 years; first-degree female relative with onset before age 65 years).
Metabolic syndrome.
HDL-C less than (<) 40 mg/dL (1.03 mmol/L).
Hypertension (blood pressure >140/90 mmHg or drug treatment).
Lipoprotein a (Lp[a]) >=50 mg/dL (1.78 µmol/L).
Tendon xanthoma.

C. Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and one of the following characteristics:

Established CHD or other cardiovascular disease (CVD; history of acute myocardial infarction, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50 percent (%), or aortic abdominal aneurysm).
Drug-treated type 2 diabetes mellitus or type 1 with target organ damage.
Family history of first- or second-degree relative with very premature onset CHD (first- or second-degree male relative with onset before age 45; first- or second-degree female relative with onset before age 55).

D. Non-FH participants suffering from established CHD or other CVD (history of acute myocardial infarction (MI), ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50%, or aortic abdominal aneurysm) and with LDL-C concentrations >=130 mg/dL (3.36 mmol/L).

E. Participants suffering from progressive CVD (coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event [acute MI, ischemic stroke, ischemia-driven revascularization, unstable angina, transient ischemic attack] occurring despite stable doses of maximally tolerated LMT) with LDL-C concentrations >=100 mg/dL (2.59 mmol/L).

Exclusion criteria:

Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment.

Use of a fibrate other than fenofibrate within 4 weeks of the screening visit (Week-3) or between screening and enrollment.

Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for participants on simvastatin 80 mg for more than one year, who were eligible).

Use of statin other than simvastatin, atorvastatin, or rosuvastatin prior to the screening visit (Week-3) or between screening and enrollment, except when there was a documented reason for intolerance to the above mentioned potent statins (in which case the use of a different statin was allowed).

Fasting serum TG >400 mg/dL (>4.52 mmol/L) at the screening visit (Week -3). Uncontrolled hypertension (>180 mmHg systolic and/or >110 mmHg diastolic at randomization visit).

New York Heart Association Class III or IV congestive heart failure persisting despite treatment.

History of hemorrhagic stroke. Liver transaminases >3 times the upper limit of normal. Laboratory evidence of current hepatitis B or C infection. Creatine kinase >3 times the upper limit of normal. Estimated glomerular filtration rate <30 mL/min/1.73 m^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception.

Male participant with a female partner of childbearing potential not protected by a highly-effective method(s) of birth control.

Participants eligible for enrollment into an ongoing clinical study of alirocumab conducted at the same investigational site.

Hypersensitivity to alirocumab or any of the excipients.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alirocumab

Arm Description

Participants received Alirocumab 150 milligram (mg) subcutaneously (SC) once every two weeks (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.

Outcomes

Primary Outcome Measures

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

Adverse Event (AE) was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Treatment-emergent AEs (TEAEs) were defined as AEs that that developed or worsened or became serious during the TEAE period (time from the first injection of study drug up to the day of the last injection of study drug + 14 days). A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event.

Secondary Outcome Measures

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Calculated LDL-C values were obtained using the Friedewald formula. Calculated LDL-C in mg/dL from Friedewald formula (LDL cholesterol = Total cholesterol - HDL cholesterol - [Triglyceride/5]). Baseline value was defined as the last observation before the first dose of the treatment.

Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12

LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <100 mg/dL (2.59 mmol/L) at week 12 were reported.

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12

LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 12 were reported.

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12

LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C <70 mg/dL at Week 12 and/or >=50% reduction from baseline in LDL-C at Week 12 are reported.

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

Baseline value was defined as the last observation before the first dose of the treatment.

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12

Baseline value was defined as the last observation before the first dose of the treatment.

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

Baseline value was defined as the last observation before the first dose of the treatment.

Percent Change From Baseline in Triglycerides at Week 12

Baseline value was defined as the last observation before the first dose of the treatment.

Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections

Pre-SIAQ: self-completed before first self-injection & Post-SIAQ: self-completed after self-injection. Pre-SIAQ consisted of 7 items grouped into 3 domains:feelings about injections,self-confidence & satisfaction with self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains:feelings about injections,self-image,self-confidence,injection-site reactions,ease of use & satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicate a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience). Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores common to the Pre & Post SIAQ were analyzed on participants belonging to Pre & Post-SIAQ population and are reported.

Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use

SIAQ: contained 2 modules: Pre-SIAQ and Post-SIAQ. Post-SIAQ: self-completed after self-injection. Post-SIAQ consisted of 21 items grouped into 6 domains: feelings about injections, self-image, self-confidence, injection-site reactions, ease of use & satisfaction with self-injection. Participants rated each item on 5-point (or 6-point) semantic Likert-type scale, where lower numbers indicated a worse experience. Item scores were transformed to obtain a score ranging from 0 (worst experience) to 10 (best experience) for each item. Transformed scores for items contributing to a domain were then averaged into a domain score. Each domain score ranges from 0 (worst experience) to 10 (best experience), higher score=better acceptability. Domain scores which are not in common with Pre-SIAQ were analyzed on the Post-SIAQ population and are reported here.

Full Information

NCT ID

NCT02476006

First Posted

June 16, 2015

Last Updated

March 21, 2022

Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02476006

Brief Title

Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Official Title

A Multi-country, Multicenter, Single-arm, Open-label Study to Document the Safety, Tolerability and Effect of Alirocumab on Atherogenic Lipoproteins in High Cardio-vascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

June 23, 2015 (Actual)

Primary Completion Date

April 12, 2019 (Actual)

Study Completion Date

April 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

Collaborators

Regeneron Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Primary Objective: To provide participants with severe hypercholesterolemia at risk for subsequent cardiovascular (CV) events and not adequately controlled with currently available lipid-modifying therapy (LMT) access to alirocumab ahead of commercial availability and to document the overall safety and tolerability of alirocumab in this participant population. Secondary Objectives: To document the effect of alirocumab on low-density lipoprotein cholesterol (LDL-C) levels as well as non-high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (total-C), high-density lipoprotein cholesterol (HDL-C), and triglyceride (TG) levels after 12 weeks of treatment. To document participant's acceptability of self-injection (Self Injection Assessment Questionnaire, SIAQ).

Detailed Description

The study duration included a screening period of up to 3 weeks, a treatment period of a minimum of 12 weeks and up to a maximum of 120 weeks (30 months), and at least 2 weeks after the last study treatment injection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

998 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Alirocumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

ALIROCUMAB SAR236553 (REGN727)

Other Intervention Name(s)

Praluent®

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

placebo (for injection training only)

Intervention Description

Pharmaceutical form:solution Route of administration: subcutaneous

Intervention Type

Drug

Intervention Name(s)

ezetimibe

Intervention Description

Pharmaceutical form:capsule Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

atorvastatin

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

rosuvastatin

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Intervention Type

Drug

Intervention Name(s)

simvastatin

Intervention Description

Pharmaceutical form:tablet Route of administration: oral

Primary Outcome Measure Information:

Title

Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

From first injection of investigational medicinal product (IMP) up to 2 weeks after last dose of study drug (Week 120)

Secondary Outcome Measure Information:

Title

Percent Change From Baseline in Calculated Low Density Lipoprotein Cholesterol (LDL-C) at Week 12

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants Reaching Calculated LDL-C <100 mg/dL (2.59 mmol/L) at Week 12

Description

LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <100 mg/dL (2.59 mmol/L) at week 12 were reported.

Time Frame

At Week 12

Title

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) at Week 12

Description

LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached calculated LDL-C <70 mg/dL (1.81 mmol/L) at week 12 were reported.

Time Frame

At Week 12

Title

Percentage of Participants Reaching Calculated LDL-C <70 mg/dL (1.81 mmol/L) and/or >=50% Reduction From Baseline in LDL-C at Week 12

Description

LDL-Cholesterol was calculated using the Friedewald formula. Percentage of participants who reached LDL-C <70 mg/dL at Week 12 and/or >=50% reduction from baseline in LDL-C at Week 12 are reported.

Time Frame

At Week 12

Title

Percent Change From Baseline in Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 12

Description

Baseline value was defined as the last observation before the first dose of the treatment.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline in Total Cholesterol (Total-C) at Week 12

Description

Baseline value was defined as the last observation before the first dose of the treatment.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline in High Density Lipoprotein Cholesterol at Week 12

Description

Baseline value was defined as the last observation before the first dose of the treatment.

Time Frame

Baseline, Week 12

Title

Percent Change From Baseline in Triglycerides at Week 12

Description

Baseline value was defined as the last observation before the first dose of the treatment.

Time Frame

Baseline, Week 12

Title

Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Feeling About Injections, Self Confidence, Satisfaction With Self-Injections

Description

Time Frame

Baseline (Pre-SIAQ), Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96

Title

Assessment of Participant's Acceptability of Self-Injection Using Self Injection Assessment Questionnaire (SIAQ): Self Image, Injection-Site Reactions, Ease of Use

Description

Time Frame

Week 4, Week 8, Week 12, Week 24, Week 48, Week 72, Week 96

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Either A, B, C, D, or E below and not adequately controlled with a maximally tolerated dose of statin with or without other LMTs, all at stable doses for at least 4 weeks prior to the screening visit (Week-3): A. Participants suffering from heterozygous familial hypercholesterolemia (heFH) with LDL-C concentrations greater than or equal to (>=)160 mg/dL (4.14 millimoles per liter [mmol/L]) despite treatment. B. Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and two or more CV risk factors among this list: LDL-C greater than (>) 250 milligrams per deciliter (mg/dL) (6.46 mmol/L) at the time of the familial hypercholesterolemia (FH) diagnosis (before treatment). Family history of premature-onset coronary heart disease (CHD; first-degree male relative with onset before age 55 years; first-degree female relative with onset before age 65 years). Metabolic syndrome. HDL-C less than (<) 40 mg/dL (1.03 mmol/L). Hypertension (blood pressure >140/90 mmHg or drug treatment). Lipoprotein a (Lp[a]) >=50 mg/dL (1.78 µmol/L). Tendon xanthoma. C. Participants suffering from heFH with LDL-C concentrations >=130 mg/dL (3.36 mmol/L) despite treatment and one of the following characteristics: Established CHD or other cardiovascular disease (CVD; history of acute myocardial infarction, ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50 percent (%), or aortic abdominal aneurysm). Drug-treated type 2 diabetes mellitus or type 1 with target organ damage. Family history of first- or second-degree relative with very premature onset CHD (first- or second-degree male relative with onset before age 45; first- or second-degree female relative with onset before age 55). D. Non-FH participants suffering from established CHD or other CVD (history of acute myocardial infarction (MI), ischemic stroke, peripheral arterial disease, coronary or peripheral arterial revascularization, stable or unstable angina, transient ischemic attack, carotid artery stenosis >=50%, or aortic abdominal aneurysm) and with LDL-C concentrations >=130 mg/dL (3.36 mmol/L). E. Participants suffering from progressive CVD (coronary artery disease, or peripheral arterial occlusive disease or cerebrovascular disease as documented clinically or by imaging techniques, with a subsequent CV event [acute MI, ischemic stroke, ischemia-driven revascularization, unstable angina, transient ischemic attack] occurring despite stable doses of maximally tolerated LMT) with LDL-C concentrations >=100 mg/dL (2.59 mmol/L). Exclusion criteria: Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) and from screening to enrollment. Use of a fibrate other than fenofibrate within 4 weeks of the screening visit (Week-3) or between screening and enrollment. Daily doses above atorvastatin 80 mg, rosuvastatin 40 mg, or simvastatin 40 mg (except for participants on simvastatin 80 mg for more than one year, who were eligible). Use of statin other than simvastatin, atorvastatin, or rosuvastatin prior to the screening visit (Week-3) or between screening and enrollment, except when there was a documented reason for intolerance to the above mentioned potent statins (in which case the use of a different statin was allowed). Fasting serum TG >400 mg/dL (>4.52 mmol/L) at the screening visit (Week -3). Uncontrolled hypertension (>180 mmHg systolic and/or >110 mmHg diastolic at randomization visit). New York Heart Association Class III or IV congestive heart failure persisting despite treatment. History of hemorrhagic stroke. Liver transaminases >3 times the upper limit of normal. Laboratory evidence of current hepatitis B or C infection. Creatine kinase >3 times the upper limit of normal. Estimated glomerular filtration rate <30 mL/min/1.73 m^2. Pregnant or breastfeeding woman or with childbearing potential without appropriate contraception. Male participant with a female partner of childbearing potential not protected by a highly-effective method(s) of birth control. Participants eligible for enrollment into an ongoing clinical study of alirocumab conducted at the same investigational site. Hypersensitivity to alirocumab or any of the excipients. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Sciences & Operations

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Investigational Site Number 040001

City

Graz

Country

Austria

Facility Name

Investigational Site Number 040008

City

Innsbruck

ZIP/Postal Code

6020

Country

Austria

Facility Name

Investigational Site Number 040005

City

Linz

ZIP/Postal Code

4010

Country

Austria

Facility Name

Investigational Site Number 040006

City

Linz

ZIP/Postal Code

4021

Country

Austria

Facility Name

Investigational Site Number 040003

City

Wien

ZIP/Postal Code

1030

Country

Austria

Facility Name

Investigational Site Number 040002

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Investigational Site Number 040004

City

Wien

ZIP/Postal Code

1130

Country

Austria

Facility Name

Investigational Site Number 040007

City

Wien

ZIP/Postal Code

1160

Country

Austria

Facility Name

Investigational Site Number 040010

City

Wien

ZIP/Postal Code

1160

Country

Austria

Facility Name

Investigational Site Number 056005

City

Aalst

ZIP/Postal Code

9300

Country

Belgium

Facility Name

Investigational Site Number 056018

City

Antwerpen

ZIP/Postal Code

2020

Country

Belgium

Facility Name

Investigational Site Number 056008

City

Arlon

ZIP/Postal Code

6700

Country

Belgium

Facility Name

Investigational Site Number 056013

City

Brugge

ZIP/Postal Code

8000

Country

Belgium

Facility Name

Investigational Site Number 056010

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Investigational Site Number 056003

City

Bruxelles

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Investigational Site Number 056006

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Investigational Site Number 056007

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

Investigational Site Number 056019

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

Investigational Site Number 056001

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Investigational Site Number 056017

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Investigational Site Number 056002

City

Haine St Paul

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Investigational Site Number 056015

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

Investigational Site Number 056009

City

La Louvière

ZIP/Postal Code

7100

Country

Belgium

Facility Name

Investigational Site Number 056004

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Investigational Site Number 056014

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Investigational Site Number 056011

City

Overpelt

ZIP/Postal Code

3900

Country

Belgium

Facility Name

Investigational Site Number 056016

City

Roeselare

ZIP/Postal Code

8800

Country

Belgium

Facility Name

Investigational Site Number 124018

City

Calgary

ZIP/Postal Code

T2E7C5

Country

Canada

Facility Name

Investigational Site Number 124015

City

Cambridge

ZIP/Postal Code

N1R6V6

Country

Canada

Facility Name

Investigational Site Number 124002

City

Chicoutimi

ZIP/Postal Code

G7H7K9

Country

Canada

Facility Name

Investigational Site Number 124027

City

Coquitlam

ZIP/Postal Code

V3K3P4

Country

Canada

Facility Name

Investigational Site Number 124025

City

Edmonton

ZIP/Postal Code

T6G2B7

Country

Canada

Facility Name

Investigational Site Number 124017

City

Halifax

ZIP/Postal Code

B3H1V7

Country

Canada

Facility Name

Investigational Site Number 124013

City

Hamilton

ZIP/Postal Code

L8L 2X2

Country

Canada

Facility Name

Investigational Site Number 124008

City

London

ZIP/Postal Code

N6A 4L6

Country

Canada

Facility Name

Investigational Site Number 124026

City

Maple Ridge

ZIP/Postal Code

V2X5Z6

Country

Canada

Facility Name

Investigational Site Number 124020

City

Montreal

ZIP/Postal Code

H2W1R7

Country

Canada

Facility Name

Investigational Site Number 124022

City

Montreal

ZIP/Postal Code

H4A3J1

Country

Canada

Facility Name

Investigational Site Number 124032

City

Mount Pearl

ZIP/Postal Code

A1N1W7

Country

Canada

Facility Name

Investigational Site Number 124005

City

Ottawa

ZIP/Postal Code

K1Y4W7

Country

Canada

Facility Name

Investigational Site Number 124024

City

Peterborough

ZIP/Postal Code

K9J0B2

Country

Canada

Facility Name

Investigational Site Number 124003

City

Quebec

ZIP/Postal Code

G1V4W2

Country

Canada

Facility Name

Investigational Site Number 124007

City

Sarnia

ZIP/Postal Code

N7T 4X3

Country

Canada

Facility Name

Investigational Site Number 124001

City

Sherbrooke

ZIP/Postal Code

J1H 5N4

Country

Canada

Facility Name

Investigational Site Number 124030

City

Smiths Falls

ZIP/Postal Code

K7A4W8

Country

Canada

Facility Name

Investigational Site Number 124019

City

St-Charles Borromee

ZIP/Postal Code

J6E6J2

Country

Canada

Facility Name

Investigational Site Number 124023

City

Toronto

ZIP/Postal Code

M4N3M5

Country

Canada

Facility Name

Investigational Site Number 124014

City

Toronto

ZIP/Postal Code

M5B1W8

Country

Canada

Facility Name

Investigational Site Number 124028

City

Trois-Rivieres

Country

Canada

Facility Name

Investigational Site Number 124011

City

Vancouver

ZIP/Postal Code

V5Y3W2

Country

Canada

Facility Name

Investigational Site Number 124012

City

Victoria

ZIP/Postal Code

V8T5G4

Country

Canada

Facility Name

Investigational Site Number 124031

City

Winnipeg

ZIP/Postal Code

R2H2A6

Country

Canada

Facility Name

Investigational Site Number 124009

City

Woodstock

ZIP/Postal Code

N4S5P5

Country

Canada

Facility Name

Investigational Site Number 203004

City

Brno

ZIP/Postal Code

65691

Country

Czechia

Facility Name

Investigational Site Number 203002

City

Hradec Kralove

ZIP/Postal Code

50005

Country

Czechia

Facility Name

Investigational Site Number 203001

City

Praha

ZIP/Postal Code

12808

Country

Czechia

Facility Name

Investigational Site Number 203005

City

Uherske Hradiste

ZIP/Postal Code

68601

Country

Czechia

Facility Name

Investigational Site Number 208001

City

Esbjerg

ZIP/Postal Code

6700

Country

Denmark

Facility Name

Investigational Site Number 208002

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Investigational Site Number 208003

City

Ålborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Investigational Site Number 246003

City

Turku

ZIP/Postal Code

20520

Country

Finland

Facility Name

Investigational Site Number 246001

City

Varkaus

ZIP/Postal Code

78300

Country

Finland

Facility Name

Investigational Site Number 250027

City

Amiens Cedex 1

ZIP/Postal Code

80054

Country

France

Facility Name

Investigational Site Number 250034

City

Auxerre

ZIP/Postal Code

89011

Country

France

Facility Name

Investigational Site Number 250016

City

Avignon

ZIP/Postal Code

84000

Country

France

Facility Name

Investigational Site Number 250021

City

Bayonne

ZIP/Postal Code

64100

Country

France

Facility Name

Investigational Site Number 250030

City

Bobigny

ZIP/Postal Code

93009

Country

France

Facility Name

Investigational Site Number 250045

City

BORDEAUX Cedex

ZIP/Postal Code

33075

Country

France

Facility Name

Investigational Site Number 250049

City

Brest Cedex

ZIP/Postal Code

29610

Country

France

Facility Name

Investigational Site Number 250054

City

Bron

ZIP/Postal Code

69677

Country

France

Facility Name

Investigational Site Number 250015

City

Caen

ZIP/Postal Code

14000

Country

France

Facility Name

Investigational Site Number 250047

City

Clermont Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

Investigational Site Number 250013

City

Corbeil Essonnes

ZIP/Postal Code

91100

Country

France

Facility Name

Investigational Site Number 250032

City

Coudray

ZIP/Postal Code

28630

Country

France

Facility Name

Investigational Site Number 250002

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Investigational Site Number 250040

City

Dijon

ZIP/Postal Code

21000

Country

France

Facility Name

Investigational Site Number 250038

City

GRENOBLE cedex

ZIP/Postal Code

38043

Country

France

Facility Name

Investigational Site Number 250012

City

Grenoble

ZIP/Postal Code

38028

Country

France

Facility Name

Investigational Site Number 250033

City

Jossigny

Country

France

Facility Name

Investigational Site Number 250035

City

LE CHESNAY Cedex

ZIP/Postal Code

78157

Country

France

Facility Name

Investigational Site Number 250036

City

Lens

Country

France

Facility Name

Investigational Site Number 250042

City

Lille

ZIP/Postal Code

59000

Country

France

Facility Name

Investigational Site Number 250004

City

Lille

Country

France

Facility Name

Investigational Site Number 250037

City

Limoges Cedex

ZIP/Postal Code

87000

Country

France

Facility Name

Investigational Site Number 250057

City

Lyon

ZIP/Postal Code

69009

Country

France

Facility Name

Investigational Site Number 250048

City

Marseille Cedex 05

ZIP/Postal Code

13385

Country

France

Facility Name

Investigational Site Number 250028

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Investigational Site Number 250024

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

Investigational Site Number 250006

City

Nantes cedex 01

ZIP/Postal Code

44093

Country

France

Facility Name

Investigational Site Number 250022

City

Nantes

ZIP/Postal Code

44277

Country

France

Facility Name

Investigational Site Number 250017

City

Nice cedex 1

ZIP/Postal Code

06001

Country

France

Facility Name

Investigational Site Number 250039

City

NIMES Cedex 9

ZIP/Postal Code

30029

Country

France

Facility Name

Investigational Site Number 250044

City

PARIS Cedex 04

ZIP/Postal Code

75181

Country

France

Facility Name

Investigational Site Number 250001

City

Paris Cedex 10

ZIP/Postal Code

75475

Country

France

Facility Name

Investigational Site Number 250014

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Investigational Site Number 250041

City

Paris

ZIP/Postal Code

75014

Country

France

Facility Name

Investigational Site Number 250026

City

Paris

ZIP/Postal Code

75018

Country

France

Facility Name

Investigational Site Number 250051

City

Pessac

ZIP/Postal Code

33604

Country

France

Facility Name

Investigational Site Number 250011

City

POITIERS Cedex

ZIP/Postal Code

86021

Country

France

Facility Name

Investigational Site Number 250031

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

Investigational Site Number 250010

City

Reims Cedex

ZIP/Postal Code

51092

Country

France

Facility Name

Investigational Site Number 250008

City

Rennes

Country

France

Facility Name

Investigational Site Number 250018

City

Rouen

ZIP/Postal Code

76000

Country

France

Facility Name

Investigational Site Number 250023

City

Saint-Mandé

ZIP/Postal Code

94160

Country

France

Facility Name

Investigational Site Number 250046

City

Toulouse Cedex 3

ZIP/Postal Code

31076

Country

France

Facility Name

Investigational Site Number 250025

City

TOULOUSE Cedex 9

ZIP/Postal Code

31059

Country

France

Facility Name

Investigational Site Number 250007

City

Tours

ZIP/Postal Code

37000

Country

France

Facility Name

Investigational Site Number 250019

City

Venissieux

ZIP/Postal Code

69200

Country

France

Facility Name

Investigational Site Number 250050

City

VICHY Cedex

ZIP/Postal Code

03201

Country

France

Facility Name

Investigational Site Number 276001

City

Berlin

ZIP/Postal Code

12559

Country

Germany

Facility Name

Investigational Site Number 276003

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

Investigational Site Number 300003

City

Ampelokipoi

ZIP/Postal Code

11522

Country

Greece

Facility Name

Investigational Site Number 300002

City

Ioannina

ZIP/Postal Code

45500

Country

Greece

Facility Name

Investigational Site Number 300001

City

Kallithea

Country

Greece

Facility Name

Investigational Site Number 348001

City

Budapest

ZIP/Postal Code

1125

Country

Hungary

Facility Name

Investigational Site Number 348002

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Investigational Site Number 348004

City

Pécs

Country

Hungary

Facility Name

Investigational Site Number 348003

City

Szeged

ZIP/Postal Code

6725

Country

Hungary

Facility Name

Investigational Site Number 616005

City

Gdansk

ZIP/Postal Code

80-952

Country

Poland

Facility Name

Investigational Site Number 616003

City

Krakow

ZIP/Postal Code

30-082

Country

Poland

Facility Name

Investigational Site Number 616001

City

Lodz

ZIP/Postal Code

90-549

Country

Poland

Facility Name

Investigational Site Number 616004

City

Olsztyn

ZIP/Postal Code

10-045

Country

Poland

Facility Name

Investigational Site Number 616002

City

Warszawa

ZIP/Postal Code

04-628

Country

Poland

Facility Name

Investigational Site Number 642-003

City

Bucuresti

ZIP/Postal Code

011461

Country

Romania

Facility Name

Investigational Site Number 642-002

City

Iasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

Investigational Site Number 642-001

City

Timisoara

ZIP/Postal Code

300298

Country

Romania

Facility Name

Investigational Site Number 703003

City

Bratislava

ZIP/Postal Code

81108

Country

Slovakia

Facility Name

Investigational Site Number 703002

City

Bratislava

ZIP/Postal Code

83101

Country

Slovakia

Facility Name

Investigational Site Number 703001

City

Kosice

ZIP/Postal Code

04011

Country

Slovakia

Facility Name

Investigational Site Number 705001

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

Investigational Site Number 724009

City

Alicante

ZIP/Postal Code

03010

Country

Spain

Facility Name

Investigational Site Number 724011

City

Alicante

ZIP/Postal Code

3550

Country

Spain

Facility Name

Investigational Site Number 724003

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Investigational Site Number 724012

City

Donostia

ZIP/Postal Code

20014

Country

Spain

Facility Name

Investigational Site Number 724014

City

Donostia

ZIP/Postal Code

20014

Country

Spain

Facility Name

Investigational Site Number 724019

City

Elche

ZIP/Postal Code

03203

Country

Spain

Facility Name

Investigational Site Number 724017

City

Galdakao

ZIP/Postal Code

48960

Country

Spain

Facility Name

Investigational Site Number 724001

City

Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Investigational Site Number 724020

City

Inca

ZIP/Postal Code

03700

Country

Spain

Facility Name

Investigational Site Number 724007

City

Las Palmas de Gran Canaria

ZIP/Postal Code

35016

Country

Spain

Facility Name

Investigational Site Number 724004

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Investigational Site Number 724008

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Investigational Site Number 724010

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Investigational Site Number 724005

City

Málaga

ZIP/Postal Code

29010

Country

Spain

Facility Name

Investigational Site Number 724002

City

Santiago de Compostela

ZIP/Postal Code

15706

Country

Spain

Facility Name

Investigational Site Number 724006

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Investigational Site Number 724016

City

Valencia

ZIP/Postal Code

46014

Country

Spain

Facility Name

Investigational Site Number 724015

City

Valladolid

ZIP/Postal Code

47011

Country

Spain

Facility Name

Investigational Site Number 756005

City

Baden

ZIP/Postal Code

5404

Country

Switzerland

Facility Name

Investigational Site Number 756002

City

Olten

ZIP/Postal Code

4600

Country

Switzerland

Facility Name

Investigational Site Number 756004

City

Reinach

ZIP/Postal Code

4153

Country

Switzerland

Facility Name

Investigational Site Number 756003

City

St. Gallen

ZIP/Postal Code

9007

Country

Switzerland

Facility Name

Investigational Site Number 756001

City

Zürich

ZIP/Postal Code

8032

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Citations:

PubMed Identifier

36064689

Citation

Cefalu AB, Garbelotto R, Mombelli G, Pirro M, Rubba P, Arca M, Borghi C, Bonomo K, Gonnelli S, Massaroni K, Tirone G, Averna M; ODYSSEY APPRISE Study Italian Investigators. A subgroup analysis of the ODYSSEY APPRISE study: Safety and efficacy of alirocumab in the Italian cohort. Nutr Metab Cardiovasc Dis. 2022 Nov;32(11):2638-2646. doi: 10.1016/j.numecd.2022.07.020. Epub 2022 Aug 9.

Results Reference

derived

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Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)

Hypercholesterolemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial