Comparison of two ways of LCZ696 titration in heart failure patients

A multicenter, randomized, double-blind, parallel group study to assess the safety and tolerability of initiating LCZ696 in heart failure patients comparing two titration regimens.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001835-33-HU

Enrollment

480

Registered

2013-08-06

Start date

2013-09-19

Completion date

Unknown

Last updated

2014-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic heart failure MedDRA version: 14.1 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849

Interventions

Product Name: LCZ696 50mg Product Code: LCZ696 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: not available Other descriptive name: LCZ696 Concentration unit: mg milligram(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 18 years. Chronic Heart Failure with New York Heart Association class II-IV. Left ventricularejection fraction = 35%. Patients must be treated with beta-blockers. Other protocol-defined inclusion criteria may apply. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 240 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240

Exclusion criteria

Exclusion criteria: Potassium > 5.2 mmol/l. Estimated glomerular filtration rate 180 mmHg. History of intolerance to recommended target doses of angiotensin converting enzyme inhibitors or angiotensin receptor blockers. Other protocol-defined exclusion criteria may apply.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.;Secondary Objective: To evaluate the proportion of patients in the two treatment groups who achieve treatment success. To evaluate the proportion of patients who tolerate a regimen of LCZ696 200 mg bid for at least 2 weeks leading to study completion.;Primary end point(s): Percentage of patients experiencing specified adverse events. Percentage of patients with systolic blood pressure 5.5 mmol/l and = 6.0 mmol/l.;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To assess the safety and tolerability of initiating LCZ696 in heart failure patients with reduced ejection fraction using conservative (reaching target dose over 6 weeks) and condensed (reaching target dose over 3 weeks) up-titration regimens.;Secondary Objective: To evaluate the proportion of patients in the two treatment groups who achieve treatment success. To evaluate the proportion of patients who tolerate a regimen of LCZ696 200 mg bid for at least 2 weeks leading to study completion.;Primary end point(s): Percentage of patients experiencing specified adverse events. Percentage of patients with systolic blood pressure 5.5 mmol/l and = 6.0 mmol/l.;Timepoint(s) of evaluation of this end point: 12 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Percentage of patients who achieve treatment success. Percentage of patients who tolerate study medication for at least the last two weeks of the study.;Timepoint(s) of evaluation of this end point: 12 weeks	—

Countries

Bulgaria, Canada, Czech Republic, Finland, Germany, Hungary, Italy, Norway, Slovakia, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactPublic Information Desk

Novartis Hungary Kft. Pharma

infoph.hungary@novartis.com+361457-6500

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026