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A Randomized Double-blind, Placebo-controlled, Multicenter Trial Assessing the Impact of Lipoprotein (a) Lowering With TQJ230 on Major Cardiovascular Events in Patients With Established Cardiovascular Disease

ClinicalTrials.gov Identifier: NCT04023552 | Novartis reference number: CTQJ230A12301 | Last updated on: May 15, 2020

 

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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Trial purpose

This is a pivotal phase 3 study designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a).

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Trial summary

condition

CONDITION

Cardiovascular Disease and Lipoprotein(a)

Phase

PHASE

Phase 3

study type

STUDY TYPE

Interventional  (Clinical Trial)

Gender

GENDER(S)

All

Age

AGE(S)

18 Years to 80 Years (Adult, Older Adult)

Accepts healthy volunteers

ACCEPTS HEALTHY VOLUNTEERS

No

Estimated completion date

ACTUAL START DATE

December 12, 2019

Estimated completion date

ESTIMATED COMPLETION DATE

March 1, 2024

estimated enrolment

ESTIMATED ENROLLMENT

7680 participants

Recruitment status

RECRUITMENT STATUS

Recruiting

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Eligibility criteria

Key Inclusion Criteria Lp(a) ≥ 70 mg/dL at the screening visit Optimal LDL-cholesterol lowering treatment Optimal treatment of other CV risk factors Myocardial infarction: ≥ 3 months to ≤ 10 years prior to the screening visit Ischemic stroke: ≥ 3 months to ≤ 10 years prior to the screening visit Clinically significant symptomatic peripheral artery disease

Key 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 ≤LLN Active liver disease or hepatic dysfunction Significant kidney disease Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria may apply at the end.

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Intervention

Drug: TQJ230

Drug: Placebo

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Trial locations

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