JRCT ID: jRCT2080225280
Registered date:17/07/2020
phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD
Basic Information
Recruitment status | completed |
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Health condition(s) or Problem(s) studied | patients with established CVD and elevated Lp(a) |
Date of first enrollment | 28/07/2020 |
Target sample size | 7680 |
Countries of recruitment | Japan,Asia except Japan,North America,South America,Europe,Oceania,Africa |
Study type | Interventional |
Intervention(s) | Drug: TQJ230 TQJ230 80 mg injected monthly administered subcutaneously Drug: Placebo Placebo to match TQJ230 prefilled syringe to be injected subcutaneously |
Outcome(s)
Primary Outcome | efficacy Time to first occurrence of clinical endpoint committee confirmed expanded major adverse cardiovascular events in patients with elevated Lp(a) =>70 mg/dL and/or => 90 mg/dL |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 18age old |
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Age maximum | <= 80age old |
Gender | Both |
Include criteria | Lp(a) =>70 mg/dL at the screening visit, measured at the Central laboratory Myocardial infarction: >= 3 months from screening and randomization to =< 10 years prior to the screening visit Ischemic stroke: =>3 months from screening and randomization to =< 10 years prior to the screening visit Clinically significant symptomatic peripheral artery disease |
Exclude criteria | Uncontrolled hypertension Heart failure New York Heart Association (NYHA) class IV History of malignancy of any organ system History of hemorrhagic stroke or other major bleeding Platelet count=<LLN Active liver disease or hepatic dysfunction Significant kidney disease Pregnant or nursing women |
Related Information
Primary Sponsor | Novartis Pharma. K.K. |
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Secondary Sponsor | |
Source(s) of Monetary Support | - |
Secondary ID(s) | NCT04023552,JapicCTI-205376 |
Contact
Public contact | |
Name | Takamitsu Hirano |
Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan |
Telephone | +81-120-003-293 |
rinshoshiken.toroku@novartis.com | |
Affiliation | Novartis Pharma. K.K. |
Scientific contact | |
Name | Takamitsu Hirano |
Address | Toranomon Hills Mori Tower 23-1, Toranomon 1-chome Minato-ku, Tokyo 105-6333, Japan |
Telephone | +81-120-003-293 |
rinshoshiken.toroku@novartis.com | |
Affiliation | Novartis Pharma. K.K. |