- Trials with a EudraCT protocol (15)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (0)
15 result(s) found for: inclisiran.
Displaying page 1 of 1.
EudraCT Number: 2016-003815-37 | Sponsor Protocol Number: MDCO-PCS-16-01 | Start Date*: 2017-02-24 | |||||||||||
Sponsor Name:Novartis Pharma AG | |||||||||||||
Full Title: An open label, active comparator extension trial to assess the effect of long term dosing of inclisiran and evolocumab given as subcutaneous injections in subjects with high cardiovascular risk and... | |||||||||||||
Medical condition: Hypercholesterolemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) NL (Ongoing) | |||||||||||||
Trial results: View results |
EudraCT Number: 2020-002755-38 | Sponsor Protocol Number: CKJX839C12302 | Start Date*: 2020-12-30 | |||||||||||
Sponsor Name:Novartis Pharma AG | |||||||||||||
Full Title: Two part (double-blind) inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2] randomized multicentre study to evaluate safety, tolerability, and efficacy of inclisiran in ad... | |||||||||||||
Medical condition: Homozygous Familial Hypercholesterolemia | |||||||||||||
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Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: SI (Completed) GR (Ongoing) NL (Ongoing) FR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-002006-27 | Sponsor Protocol Number: CKJX839B12302 | Start Date*: 2021-11-15 | |||||||||||
Sponsor Name:Novartis Pharma AG | |||||||||||||
Full Title: A randomized, double-blind, placebo -controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease... | |||||||||||||
Medical condition: Atherosclerotic cardiovascular disease (ASCVD) | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: FR (Ongoing) SK (Ongoing) PT (Ongoing) LT (Ongoing) NL (Ongoing) IT (Ongoing) AT (Ongoing) LV (Ongoing) HU (Ongoing) SE (Ongoing) DK (Ongoing) SI (Ongoing) BG (Ongoing) HR (Ongoing) NO (Ongoing) PL (Ongoing) FI (Ongoing) GR (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-002757-18 | Sponsor Protocol Number: CKJX839C12301 | Start Date*: 2020-12-21 | |||||||||||
Sponsor Name:Novartis Pharma AG | |||||||||||||
Full Title: Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in ad... | |||||||||||||
Medical condition: Heterozygous Familial Hypercholesterolemia | |||||||||||||
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Population Age: Adolescents, Under 18 | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Completed) NO (Completed) DE (Completed) SI (Ongoing) NL (Ongoing) GR (Ongoing) FR (Ongoing) IT (Ongoing) PL (Ongoing) HR (Ongoing) SK (Ongoing) CZ (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2022-001109-29 | Sponsor Protocol Number: CKJX839D12304 | Start Date*: 2022-12-06 | |||||||||||
Sponsor Name:Novartis Pharma AG | |||||||||||||
Full Title: A Double-blind, Randomized, Placebo- and Active-Comparator Controlled Study to Evaluate the Efficacy of Inclisiran as Monotherapy in Patients with Primary Hypercholesterolemia Not Receiving Lipid-L... | |||||||||||||
Medical condition: Primary Hypercholesterolemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: HU (Ongoing) DE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2022-002316-23 | Sponsor Protocol Number: CKJX839C12001B | Start Date*: 2023-01-16 | |||||||||||
Sponsor Name:Novartis Farmacéutica, S.A. | |||||||||||||
Full Title: An open-label, single arm, multicenter extension study to evaluate long-term safety and tolerability of inclisiran in participants with heterozygous or homozygous familial hypercholesterolemia who... | |||||||||||||
Medical condition: Familial Hypercholesterolemia | |||||||||||||
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Population Age: Adolescents, Under 18, Adults | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Ongoing) IT (Ongoing) NO (Trial now transitioned) DE (Ongoing) NL (Trial now transitioned) HU (Ongoing) GR (Trial now transitioned) FR (Ongoing) SI (Ongoing) PL (Trial now transitioned) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2017-005066-22 | Sponsor Protocol Number: CTSU_MDCO-PCS-17-01 | Start Date*: 2018-06-11 | |||||||||||
Sponsor Name:University of Oxford [...] | |||||||||||||
Full Title: HPS-4/TIMI 65/ORION-4: A double-blind randomized placebo-controlled trial assessing the effects of inclisiran on clinical outcomes among people with atherosclerotic cardiovascular disease | |||||||||||||
Medical condition: Atherosclerotic cardiovascular disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2017-003092-55 | Sponsor Protocol Number: MDCO-PCS-17-05 | Start Date*: 2019-02-05 | |||||||||||
Sponsor Name:The Medicines Company | |||||||||||||
Full Title: A long term extension trial of the Phase III lipid-lowering trials to assess the effect of long term dosing of inclisiran given as subcutaneous injections in subjects with high cardiovascular risk ... | |||||||||||||
Medical condition: Hypercholesterolemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (GB - no longer in EU/EEA) CZ (Completed) DE (Completed) SE (Completed) DK (Completed) HU (Completed) NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-002472-30 | Sponsor Protocol Number: MDCO-PCS-17-03 | Start Date*: 2018-01-04 | |||||||||||
Sponsor Name:The Medicines Company | |||||||||||||
Full Title: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEM... | |||||||||||||
Medical condition: Hypercholesterolemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: GB (Completed) ES (Completed) CZ (Completed) SE (Completed) DK (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2017-001846-90 | Sponsor Protocol Number: MDCO-PCS-17-08 | Start Date*: 2017-12-12 | |||||||||||
Sponsor Name:The Medicines Company | |||||||||||||
Full Title: A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL TO EVALUATE THE EFFECT OF 300 MG OF INCLISIRAN SODIUM GIVEN AS SUBCUTANEOUS INJECTIONS IN SUBJECTS WITH ATHEROSCLEROTIC CARDIOVASCULAR DISEASE (... | |||||||||||||
Medical condition: Hypercholesterolemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) HU (Completed) GB (Completed) CZ (Completed) NL (Completed) | |||||||||||||
Trial results: View results |
EudraCT Number: 2021-003759-40 | Sponsor Protocol Number: CKJX839A12402 | Start Date*: 2022-02-14 | |||||||||||
Sponsor Name:Novartis Pharma AG | |||||||||||||
Full Title: Efficacy, safety, tolerability and quality of life of ongoing individually optimized lipid-lowering therapy with or without inclisiran (KJX839) – a randomized, placebo-controlled, double-blind mul... | |||||||||||||
Medical condition: Hypercholesterolemia | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: ES (Ongoing) DE (Ongoing) BG (Ongoing) LV (Ongoing) EE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-004601-47 | Sponsor Protocol Number: CKJX839D12303 | Start Date*: 2022-05-09 | |||||||||||
Sponsor Name:NOVARTIS PHARMA AG | |||||||||||||
Full Title: A multi-center, randomized, double-blind, placebo controlled, parallelgroup Phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed ... | |||||||||||||
Medical condition: Non-obstructive coronary artery disease | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: IT (Ongoing) HU (Ongoing) ES (Ongoing) IE (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2021-005602-10 | Sponsor Protocol Number: 1.1 | Start Date*: 2022-01-20 |
Sponsor Name:Verein zur Förderung der Forschung auf dem Gebiet der Arteriosklerose, Thrombose und vaskulären Biologie (ATVB) | ||
Full Title: POESIA Study: Pleiotropic effects of PCSK 9 inhibition and bempedoic acid - Changes in Platelet Function and Inflammation Markers | ||
Medical condition: platelet activity and inflammation markers in patients with coronary artery disease | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: AT (Ongoing) | ||
Trial results: (No results available) |
EudraCT Number: 2021-002871-20 | Sponsor Protocol Number: LIB003-012 | Start Date*: 2022-04-21 | |||||||||||
Sponsor Name:LIB Therapeutics, LLC | |||||||||||||
Full Title: Randomized, Open Label, Phase 3 Study to Evaluate the Efficacy and Safety of Lerodalcibep (LIB003) compared to Inclisiran in Patients With Cardiovascular Disease, or at High Risk for Cardiovascula... | |||||||||||||
Medical condition: Patients with atherosclerotic cardiovascular (CV) disease (ASCVD) or high risk of ASCVD who need additional LDL-C reduction | |||||||||||||
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Population Age: Adults, Elderly | Gender: Male, Female | ||||||||||||
Trial protocol: DE (Completed) NO (Completed) ES (Ongoing) | |||||||||||||
Trial results: (No results available) |
EudraCT Number: 2020-001000-42 | Sponsor Protocol Number: 1144/2020 | Start Date*: 2020-07-09 |
Sponsor Name:Medical University of Vienna | ||
Full Title: The relationship of cholesterol-lowering drugs with steroid HORMONEs, bile acids, vitamin D, the immune system and related diseases such as depression and osteoporosis | ||
Medical condition: Patients with a diagnosed hyperlipidemia treated with statins (with either simvastatin <=20 mg, atorvastatin <=10 mg or rosuvastatin <=10 mg - random allocation), or with atorvastatin >=40 mg or r... | ||
Disease: | ||
Population Age: Adults, Elderly | Gender: Male, Female | |
Trial protocol: AT (Ongoing) | ||
Trial results: (No results available) |
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