Informations générales (source: ClinicalTrials.gov)
The Cardiovascular Safety and Efficacy of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) Once-weekly in Participants With Established Cardiovascular Disease (REDEFINE 3)
Interventional
Phase 3
Novo Nordisk A/S (Voir sur ClinicalTrials)
mars 2023
octobre 2027
10 octobre 2024
This study will look at the effects of CagriSema on cardiovascular events (for example
heart attack and stroke) in people living with cardiovascular disease. Participants will
either get CagriSema or a dummy medicine (also called "placebo") which has no effect on
the body. Which treatment participants will get will be decided by chance. Participant's
chance of getting CagriSema or placebo is the same. Participants will inject the study
medicine once a week. The study medicine will be injected briefly with a thin needle,
typically in the stomach, thighs or upper arms. The study will last for up to 4.5 years.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL NOVO | CAMPINOS | 04/07/2024 11:05:05 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Avicenne | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital La Pitié-Salpêtrière | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Recherche Clinique Portes Du Sud - 69200 - Venissieux - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Ardeche Nord - 07103 - Annonay cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Bretagne Atlantique - 56000 - Vannes - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier d'Annonay - 07100 - Annonay - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Lille-Hopital Claude Huriez - 59000 - Lille - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire de Montpellier-Hopital Lapeyronie - 34090 - Montpellier - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-2 - 38043 - Grenoble cedex 9 - France | Contact (sur clinicalTrials) | ||||
| CH Louis Pasteur - 28630 - Le Coudray - France | Contact (sur clinicalTrials) | ||||
| Groupe Hospitalier Du Havre - 76600 - Le Havre - France | Contact (sur clinicalTrials) | ||||
| Les Hopitaux de Chartres-Hopital Louis Pasteur - 28630 - Le Coudray - France | Contact (sur clinicalTrials) | ||||
| RESEAU DE SANTE MUTUALISTE-Médipôle Hôpital Mutualiste - 69100 - Villeurbanne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- Male or female
- Age above or equal to 55 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square
(kg/m^2)
- Established CVD as evidenced by at least one of the following:
1. Prior myocardial infarction
2. Prior stroke (ischemic or haemorrhagic stroke)
3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the
following:
1. Intermittent claudication with an ankle-brachial index (ABI) less than (<)
0.85 at rest
2. Intermittent claudication with a >= 50% stenosis in a lower extremity
peripheral artery documented by X-ray angiography, magnetic resonance (MR)
angiography, computed tomography (CT) angiography or Doppler ultrasound
3. Prior revascularization procedure of a lower extremity peripheral artery
4. Lower extremity amputation at or above ankle due to atherosclerotic
disease (excluding e.g., trauma or osteomyelitis)
For participants with T2D at screening the following inclusion criteria also apply:
- Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening
- HbA1c 6.5%-10% (48-86 millimoles per mole [mmol/mol]) (both inclusive), as measured
by central laboratory at screening
- Treatment with either:
1. Lifestyle intervention alone
2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase
inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i),
dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas
(SU) as a single agent or in combination) according to local label
3. Basal insulin alone or in combination with up to two marketed OADs, all
according to local label
- Male or female
- Age above or equal to 55 years at the time of signing informed consent
- Body mass index (BMI) greater than or equal to (>=) 25.0 kilograms per meter square
(kg/m^2)
- Established CVD as evidenced by at least one of the following:
1. Prior myocardial infarction
2. Prior stroke (ischemic or haemorrhagic stroke)
3. Symptomatic peripheral arterial disease (PAD) defined as at least one of the
following:
1. Intermittent claudication with an ankle-brachial index (ABI) less than (<)
0.85 at rest
2. Intermittent claudication with a >= 50% stenosis in a lower extremity
peripheral artery documented by X-ray angiography, magnetic resonance (MR)
angiography, computed tomography (CT) angiography or Doppler ultrasound
3. Prior revascularization procedure of a lower extremity peripheral artery
4. Lower extremity amputation at or above ankle due to atherosclerotic
disease (excluding e.g., trauma or osteomyelitis)
For participants with T2D at screening the following inclusion criteria also apply:
- Diagnosed with type 2 diabetes mellitus (T2D) >= 180 days before screening
- HbA1c 6.5%-10% (48-86 millimoles per mole [mmol/mol]) (both inclusive), as measured
by central laboratory at screening
- Treatment with either:
1. Lifestyle intervention alone
2. 1-3 marketed oral antidiabetic drugs (OADs) (metformin, α-glucosidase
inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitor (SGLT2i),
dipeptidyl peptidase 4 (DPP4)-inhibitors, thiazolidinediones, or sulphonylureas
(SU) as a single agent or in combination) according to local label
3. Basal insulin alone or in combination with up to two marketed OADs, all
according to local label
- Myocardial infarction, stroke, hospitalization for unstable angina pectoris or
transient ischaemic attack within 60 days before screening
- Planned coronary, carotid or peripheral artery revascularisation known on the day of
screening
- Heart failure classified as being in New York Heart Association (NYHA) Class IV at
screening
- Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or a
medication with GLP-1 activity within 90 days before screening
- End stage renal disease defined as estimated glomerular filtration rate (eGFR) < 15
millileters per minutes per 1.73^2 (mL/min/1.73 m^2), as measured by the central
laboratory at screening
- Chronic or intermittent haemodialysis or peritoneal dialysis