NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
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
Health condition(s) or Problem(s) studiedpatients with established CVD and elevated Lp(a)
Date of first enrollment28/07/2020
Target sample size7680
Countries of recruitmentJapan,Asia except Japan,North America,South America,Europe,Oceania,Africa
Study typeInterventional
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 Outcomeefficacy 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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 80age old
GenderBoth
Include criteriaLp(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 criteriaUncontrolled 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

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
E-mail 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
E-mail rinshoshiken.toroku@novartis.com
Affiliation Novartis Pharma. K.K.