Comparison of two ways of LCZ696 titration in heart failure patients

• Register: EUCTR
• Last refreshed on: 28 February 2019
• Main ID: EUCTR2013-001835-33-GB
• Date of registration: 19/11/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma services AG
• Public title: Comparison of two ways of LCZ696 titration in heart failure patients
• Scientific title: 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.
• Date of first enrolment: 31/12/2013
• Target sample size: 480
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-001835-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Comparison of two up-titration regimens with LCZ696 Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

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

Contacts

• Name: Medical Collaboration Centre
• Affiliation: Novartis Pharmaceuticals UK Limited

• Name: Medical Collaboration Centre
• Affiliation: Novartis Pharmaceuticals UK Limited

Key inclusion & exclusion 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:
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 exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Chronic heart failure
MedDRA version: 20.0 Level: LLT Classification code 10008908 Term: Chronic heart failure System Organ Class: 100000004849

Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

Intervention(s)

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)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: LCZ696 100mg
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LCZ696
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Product Name: LCZ696 200mg
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: not available
Other descriptive name: LCZ696
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

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.

Primary end point(s): Percentage of patients experiencing specified adverse events.
Percentage of patients with systolic blood pressure < 95 mmHg.
Percentage of patients with abnormal serum creatinine and doubling of serum creatinine.
Percentage of patients with Serum potassium > 5.5 mmol/l and = 6.0 mmol/l.

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.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 12 weeks

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.

Secondary ID(s)

2013-001835-33-HU

CLCZ696B2228

Source(s) of Monetary Support

Novartis Pharma Services AG

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 06/08/2015
• Date Completed: 05/08/2014
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001835-33/results