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The trial is taking place at:
A

Advanced Research for Health Improvement, LLC | Naples, FL

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A Multicenter Trial Assessing the Impact of Lipoprotein(a) Lowering With Pelacarsen (TQJ230) on the Progression of Calcific Aortic Valve Stenosis

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Novartis

Status and phase

Enrolling
Phase 2

Conditions

Aortic Stenosis

Treatments

Drug: Matching placebo
Drug: Pelacarsen (TQJ230) 80mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT05646381
CTQJ230A12203

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy, safety and tolerability of pelacarsen (TQJ230) administered subcutaneously once monthly compared to placebo in slowing the progression of calcific aortic valve stenosis.

Enrollment

502 estimated patients

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male and female ≥50 to <80 years of age
  • Lp(a) ≥175 nmol/L at the screening visit, measured at the Central laboratory
  • Mild or moderate calcific aortic valve stenosis
  • At the randomization visit, participant must be optimally treated for existing CV risk factors

Exclusion criteria

  • Severe calcific aortic valve stenosis
  • Uncontrolled hypertension
  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

502 participants in 2 patient groups, including a placebo group

Pelacarsen (TQJ230) 80mg
Experimental group
Description:
Pelacarsen (TQJ230) 80 mg prefilled syringe injected monthly, administered subcutaneously
Treatment:
Drug: Pelacarsen (TQJ230) 80mg
Matching placebo
Placebo Comparator group
Description:
Placebo to match pelacarsen (TQJ230) prefilled syringe injected monthly, administered subcutaneously
Treatment:
Drug: Matching placebo

Trial contacts and locations

27

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Central trial contact

Novartis Pharmaceuticals; Novartis Pharmaceuticals

Data sourced from clinicaltrials.gov

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