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Safety and Tolerability of Initiating LCZ696 in Heart Failure Patients (TITRATION)

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Novartis

Status and phase

Completed
Phase 2

Conditions

Heart Failure With Reduced Ejection Fraction

Treatments

Drug: LCZ696

Study type

Interventional

Funder types

Industry

Identifiers

NCT01922089
2013-001835-33 (EudraCT Number)
CLCZ696B2228

Details and patient eligibility

About

The purpose of this study is to assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction (HF-rEF) using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.

Enrollment

498 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age ≥ 18 years; CHF with New York Heart Association class II-IV; left ventricular ejection fraction ≤ 35%; on beta blockers

Exclusion criteria

  • Potassium > 5.2 mmol/l; estimated glomerular filtration rate < 30 ml/min/1.73 m2; systolic blood pressure <100 mmHg or > 180 mmHg; history of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

498 participants in 2 patient groups

LCZ696 Condensed
Experimental group
Description:
Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
Treatment:
Drug: LCZ696
LCZ696 Conservative
Experimental group
Description:
Up-titration to LCZ696 200 mg bid over 6 weeks
Treatment:
Drug: LCZ696

Trial contacts and locations

105

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Data sourced from clinicaltrials.gov

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