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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 11 March 2020
Main ID:  EUCTR2019-003098-24-ES
Date of registration: 02/12/2019
Prospective Registration: Yes
Primary sponsor: Novartis Farmacéutica, S.A.
Public title: Study of efficacy of oral sacubitril/valsartan adult patients with non-obstructive hypertrophic cardiomyopathy
Scientific title: A multi-center, randomized, placebo-controlled patient and investigator-blinded study to explore the efficacy of oral sacubitril/valsartan in adult patients with non-obstructive hypertrophic cardiomyopathy (nHCM)
Date of first enrolment: 19/02/2020
Target sample size: 44
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-003098-24
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: yes
Other: no
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
Finland Germany Greece Korea, Republic of Spain United Kingdom United States
Contacts
Name: Trial Monitoring Organization (TMo)   
Address:  Gran Vía de les Corts Catalanes, 764 08013 Barcelona Spain
Telephone: +34 90 0353036
Email: eecc.novartis@novartis.com
Affiliation:  Novartis Farmacéutica, S.A.
Name: Trial Monitoring Organization (TMo)   
Address:  Gran Vía de les Corts Catalanes, 764 08013 Barcelona Spain
Telephone: +34 90 0353036
Email: eecc.novartis@novartis.com
Affiliation:  Novartis Farmacéutica, S.A.
Key inclusion & exclusion criteria
Inclusion criteria:
• Diagnosed with Hypertrophic Cardiomyopathy with a left ventricular wall thickness greater than or equal to 13mm as determined by the echocardiogram obtained during the screening/baseline period
• Left ventricular ejection fraction (LVEF) greater than or equal to 50% as determined by echocardiogram obtained during the screening/baseline period
• Symptoms consistent with New York Heart Association (NYHA) Class II-III heart failure by physician assessment, or asymptomatic/NYHA Class I patients with:
o NT-proBNP blood sample levels above 250 pg/ml and
o peak VO2 of <80% of predicted based on age and gender as determined by cardiopulmonary exercise testing
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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion criteria:
• Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for =7 days after stopping study drug
• Patients with a resting or provokable left ventricular outflow tract gradient of greater than or equal to 30mm Hg
• Septal reduction procedure within 3 months of the screening/baseline visit
• History of atrial fibrillation or placement of ICD for secondary prevention
• Patients with a peak VO2 on the screening/baseline cardiopulmonary exercise test of >80% of predicted based on age and gender
• Patients who require treatment with ACE inhibitors, angiotensin receptor blockers (ARBs), or renin inhibitors
• Known infiltrative or storage disorder such as Fabry disease, or amyloidosis
• Known or suspected symptomatic coronary artery diseases or evidence of prior myocardial infarction
• Systolic blood pressure of <100 mmHg or symptomatic hypotension during the screening/baseline period or treatment run-in period
• Contraindication to ARB administration or prior history of angioedema
• Persistent uncontrolled hypertension
Other protocol-defined inclusion/exclusion criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
non-obstructive hypertrophic cardiomyopathy
MedDRA version: 20.0 Level: PT Classification code 10020871 Term: Hypertrophic cardiomyopathy System Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Intervention(s)

Trade Name: Entresto
Product Name: LCZ696 50 mg
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
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

Trade Name: Entresto
Product Name: LCZ696 100 mg
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
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

Trade Name: Entresto
Product Name: LCZ696 200 mg
Product Code: LCZ696
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: sacubitril/valsartan
Other descriptive name: SACUBITRIL VALSARTAN
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)
Main Objective: To evaluate the effect of LCZ696 on cardiopulmonary exercise test (CPET) parameters in patients with non-obstructive HCM
Primary end point(s): Change from baseline in peak VO2 as measured by cardiopulmonary exercise test (CPET)
Secondary Objective: To evaluate the safety and tolerability of LCZ696 in patients with non-obstructive HCM
Timepoint(s) of evaluation of this end point: Baseline to 50 weeks
Secondary Outcome(s)
Secondary end point(s): Adverse events (AEs), vital signs, ECGs, physical examinations and safety labs
Timepoint(s) of evaluation of this end point: Over numerous visits until end of study
Secondary ID(s)
2019-003098-24-DE
CLCZ696I12201
Source(s) of Monetary Support
Novartis Pharma AG
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/02/2020
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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