phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD
Phase 3
Completed
- Conditions
- patients with established CVD and elevated Lp(a)
- Registration Number
- JPRN-jRCT2080225280
- Lead Sponsor
- ovartis Pharma. K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 7680
Inclusion 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
Exclusion 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=Active liver disease or hepatic dysfunction
Significant kidney disease
Pregnant or nursing women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method