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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01920711




Registration number
NCT01920711
Ethics application status
Date submitted
8/08/2013
Date registered
12/08/2013

Titles & IDs
Public title
Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients With Preserved Ejection Fraction
Scientific title
A Multicenter, Randomized, Double-blind, Parallel Group, Active-controlled Study to Evaluate the Efficacy and Safety of LCZ696 Compared to Valsartan, on Morbidity and Mortality in Heart Failure Patients (NYHA Class II-IV) With Preserved Ejection Fraction (PARAGON-HF)
Secondary ID [1] 0 0
2013-001747-31
Secondary ID [2] 0 0
CLCZ696D2301
Universal Trial Number (UTN)
Trial acronym
PARAGON-HF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure With Preserved Ejection Fraction 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LCZ696
Treatment: Drugs - Valsartan

Experimental: LCZ696 - Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of LCZ696 during the double blind period is 200 mg b.i.d.

Active comparator: Valsartan - Single Blind Run-in Period (3-8 weeks): Patients will start on Valsartan 80 mg b.i.d. for 1-2 weeks followed by LCZ696 100 mg b.i.d. for 2-4 weeks prior to randomization into the Double Blind period (up to 57 months). Patients can only be randomized from the run-in period if they meet all of the run-in safety criteria. Target dose of Valsartan during the double blind period is 160 mg b.i.d.


Treatment: Drugs: LCZ696
LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.

Treatment: Drugs: Valsartan
Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative Number of Primary Composite Events of Cardiovascular (CV) Death and Total (First and Recurrent) HF Hospitalizations.
Timepoint [1] 0 0
Total follow up time (up to 57 months)
Secondary outcome [1] 0 0
Change in the Clinical Summary Score From Baseline to Month 8 by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Timepoint [1] 0 0
Baseline, 8 months
Secondary outcome [2] 0 0
Change From Baseline to Month 8 in New York Heart Association (NYHA) Functional Class
Timepoint [2] 0 0
Baseline, 8 months
Secondary outcome [3] 0 0
Participants With First Occurrence of a Composite Renal Endpoint
Timepoint [3] 0 0
Randomization to total follow-up time (up to 57 months)
Secondary outcome [4] 0 0
All-cause Mortality
Timepoint [4] 0 0
Randomization to total follow up time (up to 57 months)

Eligibility
Key inclusion criteria
* Left ventricular ejection fraction (LVEF) =45% by echo during screening epoch or within 6 months prior to study entry.
* Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF at least 30 days prior to study entry.
* Current symptom(s) of HF (NYHA class II-IV)
* Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by echocardiogram.
* Elevated NT-proBNP
Minimum age
50 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any prior measurement of LVEF < 40%.
* Acute coronary syndrome (including MI), cardiac surgery, other major CV surgery within 3 months , or urgent percutaneous coronary intervention within 3 months or and elective PCI within 30 days prior to entry.
* Any clinical event within the 6 months prior to entry could have reduced the LVEF (e.g., MI, CABG), unless an echo measurement performed after the event confirms a LVEF =45%.
* Current acute decompensated HF requiring therapy.
* Patients who require treatment with 2 or more of the following: an angiotensin converting enzyme inhibitor (ACEI), an angiotensin receptor blocker (ARB) or a renin inhibitor.
* Alternative reason for shortness of breath such as: significant pulmonary disease or severe COPD, hemoglobin (Hgb) <10 g/dl, or body mass index (BMI) > 40 kg/m2.
* Systolic blood pressure (SBP) = 180 mmHg at entry, or SBP >150 mmHg and <180 mmHg at entry unless the patient is receiving 3 or more antihypertensive drugs, or SBP < 110 mmHg at entry.

Other protocol-defined inclusion/exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/06/2019
Sample size
Target
Accrual to date
Final
4822
Recruitment in Australia
Recruitment state(s)
QLD,SA,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Southport
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Novartis Investigative Site - Bedford Park
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Novartis Investigative Site - Bundoora
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Novartis Investigative Site - Epping
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Novartis Investigative Site - Geelong
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4215 - Southport
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5041 - Bedford Park
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3083 - Bundoora
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3076 - Epping
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3220 - Geelong
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Kerala
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India
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Maharashtra
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India
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India
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India
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India
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West Bengal
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India
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Israel
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Israel
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Israel
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Rehovot
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Israel
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AO
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UD
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Va
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VE
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Den Haag
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Ede
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Grodzisk Mazowiecki
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Sandomierz
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Poland
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Poland
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Torun
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Poland
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Poland
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Warszawa
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Poland
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Zabrze
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Poland
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Zamosc
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Jud. Dolj
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Romania
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Romania
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Russian Federation
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Russian Federation
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Russian Federation
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Russian Federation
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Smolensk
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Russian Federation
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Russian Federation
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St-Petersburg
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Russian Federation
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St.- Petersburg
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Russian Federation
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Yaroslavl
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Serbia
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Serbia
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Serbia
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Serbia
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Nis
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Singapore
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Sweden
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TUR
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United Kingdom
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Cleveland
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United Kingdom
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Co Durham
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United Kingdom
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County Durham
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United Kingdom
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Devon
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Dorset
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GBR
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Hampshire
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United Kingdom
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Lancashire
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United Kingdom
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Middlesex
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United Kingdom
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Nothern Ireland
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United Kingdom
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Peterborough
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United Kingdom
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Scotland
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Somerset
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United Kingdom
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Tyne And Wear
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United Kingdom
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West Dumbartonshire
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United Kingdom
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Cheshire
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United Kingdom
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Coventry
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United Kingdom
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Dundee
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United Kingdom
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Glasgow
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United Kingdom
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Hull
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United Kingdom
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London
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Newport
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Nottingham
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Sheffield
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Wiltshire
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United Kingdom
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Wrexham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01920711