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Trial details
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure- PANORAMA
Current status:
Approved
|
Date registered:
08/07/2019
Trial version(s)
History: 07/04/2019
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History: 07/04/2019
Current: 07/04/2019
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Main Information
Primary registry identifying number
LBCTR2019040224
Protocol number
CLCZ696B2319
MOH registration number
22659/2018
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Retrospective
Type of registration: Justify
LCTR was recently initiated, original file was previously submitted by Paper
Date of registration in national regulatory agency
29/05/2018
Primary sponsor
Novartis Pharma Services Inc.
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LCZ696 Followed by a 52-week Study of LCZ696 Compared With Enalapril in Pediatric Patients With Heart Failure- PANORAMA
Acronym
PANORAMA
Scientific title
Multicenter, Open-label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCZ696 Followed by a 52-week Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared With Enalapril in Pediatric Patients From 1 Month to < 18 Years of Age With Heart Failure Due to Systemic Left Ventricle Systolic Dysfunction
Acronym
Brief summary of the study: English
This study consist of two parts (Part 1 and Part 2). The purpose of Part 1 is to evaluate the way the body absorbs, distributes and removes the drug LCZ696. This will help determine the proper dose of LCZ696 for Part 2 of the study. The purpose for Part 2 is to compare the effectiveness and safety of LCZ696 with enalapril in pediatric heart failure patients over 52 weeks of treatment.
Brief summary of the study: Arabic
دراسة متعددة المراكز، مفتوحة العنوان؛ لتقييم الأمان والتحمل والحركيات الدَّوائية والديناميكيات الدَّوائية لعقار LCZ696 تليها دراسة لمدة 52 أسبوعًا عشوائية، مزدوجة التَّعمية، من مجموعات علاج متوازية، مُضبَطة بعقار فعَّال، ؛ لتقييم أمان وفعالية عقار LCZ696 مقارنة بعقار إنالابريل في الأطفال المرضى الذين تتراوح أعمارهم بين شهر واحد إلى أقل من 18 سنة و يعانون من فشل القلب بسبب قصور جهازي بوظائف انقباض البطين الأيسر
Health conditions/problem studied: Specify
Cardiovascular / Pediatric Heart Failure
Interventions: Specify
Drug: LCZ696 LCZ696: 3.125 mg granules (packaged in capsules containing 4 or 10 granules), 50 mg, 100 mg, 200 mg dosage strengths Drug: Enalapril Enalapril will be open label in Part 1 and double blind in Part 2 Drug: Placebo of LCZ696 Drug: Placebo of Enalapril
Key inclusion and exclusion criteria: Inclusion criteria
Chronic heart failure resulting from left ventricular systolic dysfunction, and receiving chronic HF therapy (if not newly diagnosed) NYHA classification II-IV (older children: 6 to <18 years old) or Ross CHF classification II-IV (younger children: < 6 years old) Systemic left ventricular ejection fraction ≤ 40% or fractional shortening ≤20% For Part 1 study: Patients must be treated with an ACEI or ARB prior to screening. Patients in Group 1 and 2 must be currently treated with the dose equivalent of at least enalapril 0.2 mg/kg prior to the LCZ696 3.1 mg/kg administration. Group 3 patients will participate in LCZ696 0.8 mg/kg and not LCZ696 3.1 mg/kg. Biventricular physiology with systemic left ventricle
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
1
Key inclusion and exclusion criteria: Age maximum
17
Key inclusion and exclusion criteria: Exclusion criteria
Patient with single ventricle or systemic right ventricle Patients listed for heart transplantation (as United Network for Organ Sharing status 1A) or hospitalized waiting for transplant (while on inotropes or with ventricular assist device) Sustained or symptomatic dysrhythmias uncontrolled with drug or device therapy Patients that have had cardiovascular surgery or percutaneous intervention to palliate or correct congenital cardiovascular malformations within 3 months of the screening visit. Patients anticipated to undergo corrective heart surgery during the 12 months after entry into Part 2 Patients with unoperated obstructive or severe regurgitant valvular (aortic, pulmonary, or tricuspid) disease, or significant systemic ventricular outflow obstruction or aortic arch obstruction Patients with restrictive or hypertrophic cardiomyopathy Active myocarditis Renal vascular hypertension (including renal artery stenosis) Moderate-to severe obstructive pulmonary disease Serum potassium > 5.3 mmol/L History of angioedema Allergy or hypersensitivity to ACEI / ARB
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Therapy
Trial scope: Specify scope
Study design: Allocation
Randomized controlled trial
Study design: Masking
Blinded (masking used)
Study design: Control
Active
Study phase
3
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
Yes, Lebanon and Worldwide
IMP has market authorization: Specify the countries
Approved for Adults use only : France, Germany, Belgium, UK, USA, KSA, UAE, Turkey
Name of IMP
LCZ696 Entresto
Year of authorization
2016
Month of authorization
3
Type of IMP
Others
Type of IMP: Specify
angiotensin receptor neprilysin inhibitor
Pharmaceutical class
angiotensin receptor neprilysin inhibitor
Therapeutic indication
Chronic Heart Failure
Therapeutic benefit
Global Rank endpoint through 52 weeks of Treatment
Biospecimen retention
Samples without DNA
Biospecimen description
Biological samples : Urine, Hematology, Chemistry will be sent to Clinical Reference Laboratory, Europe Ltd. 7310 Cambridge Research Park Beach Drive, Waterbeach Cambridge, CB25 9TN United Kingdom
Target sample size
8
Actual enrollment target size
4
Date of first enrollment: Type
Actual
Date of first enrollment: Date
17/08/2018
Date of study closure: Type
Actual
Date of study closure: Date
29/10/2021
Recruitment status
Recruiting
Date of completion
30/04/2020
IPD sharing statement plan
No
IPD sharing statement description
Not provided
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT02678312?term=pediatric&cond=Cardiovascular+Diseases&cntry=LB&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
Clinicaltrials.gov
NCT02678312
Sources of Monetary or Material Support
Name
Novartis Pharma Services Inc.
Secondary Sponsors
Name
NA
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ghassan
Chehab
Beirut
Lebanon
009613388581
ghassanchehab@yahoo.com
Rafik Hariri University Hospital
Scientific
Hind
Khairallah
Sin El Fil
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@fattal.com.lb
Khalil Fattal et Fils s.a.l.
Public
Linda
Daou
Beirut
Lebanon
009613524424
drlindadaou@gmail.com
Hotel Dieu De France
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
Hotel Dieu De France
Dr Linda Daou
Pediatric Cardiologist
Approved
Rafik Hariri University Hospital
Dr Ghassan Chehab
Pediatric Cardiologist
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
Hotel Dieu de France
27/02/2018
Nancy Alam
nancy.alam@usj.edu.lb
+961 (0) 1 421000 ext 2335
Rafic Hariri University Hospital
09/01/2018
Rawan Yamout
rawan.yamout@crurhuh.com
018300000 ext 2036
Countries of Recruitment
Name
Lebanon
Argentina
Bulgaria
Canada
China
Croatia
Finland
France
Hungary
Japan
Jordan
Turkey
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Heart Failure
Heart failure, unspecified (I50.9)
HF
Interventions
Intervention
Description
Keyword
Physical Exam, Vital signs, ECG, Echocardiography, Urinalysis, Serum/ urine pregnancy test, lab test, completion of QoL questionnaires
Physical Exam, Vital signs, ECG, Echocardiography, Urinalysis, Serum/ urine pregnancy test, lab test, completion of QoL questionnaires
ICF, Lab, IMP, radiology
Primary Outcomes
Name
Time points
Measure
Percentage of patients falling into each category based on global ranking
52 weeks
52 weeks
The global ranking is based on clinical events such as death, listing for urgent heart transplant, mechanical life support requirement at end of study, worsening heart failure (HF), New York Heart Association (NYHA)/Ross, Patient Global Impression of Severity (PGIS), Pediatric Quality of Life Inventory (PedsQL) physical functioning domain. The primary endpoint will be derived based on 5 categories ranking worst to best outcome
52 weeks
52 weeks
Key Secondary Outcomes
Name
Time points
Measure
Time to first occurrence of Category 1 or Category 2 event
52 weeks
52 weeks
Change from baseline in NYHA/Ross functional class
52 weeks
52 weeks
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
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Save a PDF copy of the summary of the trial