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EUCTR2013-001747-31

A study to evaluate the efficacy and safety of LCZ969 in heart failure patients with preserved ejection fraction.

Data source: WHO (Imported from 29.03.2024)
Changed: Dec 6, 2020, 1:02 AM
Disease category:

Health conditions (Data source: WHO)

Heart failure with preserved ejection fraction
MedDRA version: 17.0Level: LLTClassification code 10069211Term: Diastolic heart failureSystem Organ Class: 100000004849
MedDRA version: 17.0Level: LLTClassification code 10019279Term: Heart failureSystem Organ Class: 100000004849;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Interventions (Data source: WHO)


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

Trade Name: Diovan
Product Name: Diovan 40mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VALSARTAN
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Diovan
Product Name: Diovan 80mg
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: VALSARTAN
CAS Number: 137862-53-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 80-
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use

Trade Name: Diovan
Product Name: Diovan 160mg
Pharmaceutical Form: Film-coated tablet
INN o

Inclusion/Exclusion Criteria (Data source: WHO)

Inclusion criteria:
- Left ventricular ejection fraction (LVEF) =45% prior to study entry.
- Symptom(s) of heart failure (HF) and requiring treatment with diuretic(s) for HF =30 days prior to study entry.
- Current symptom(s) of HF.
- Structural heart disease (left atrial enlargement or left ventricular hypertrophy) documented by
echocardiogram.
- At least one of the following: a HF hospitalization within 9 months prior to study entry and/or an elevated NT-proBNP.
- 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 990
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3310

Exclusion criteria:
- Any prior measurement of LVEF < 45%.
- Acute coronary syndrome (including myocardial infarction (MI)), cardiac surgery, other major cardiovascular surgery within 3 months, or urgent percutaneous coronary intervention (PCI) within 30 days of entry.
- Patients who have had an MI, coronary artery bypass graft (CABG) or other event within the 6 months prior to entry 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.
- Other protocol-defined exclusion criteria may apply.

Further information on the trial from WHO database (ICTRP)

https://trialsearch.who.int/Trial2.aspx?TrialID=EUCTR2013-001747-31
Further information on trial

Date trial registered

Aug 26, 2014

Incorporation of the first participant

Sep 12, 2014

Recruitment status

Not Recruiting

Academic title (Data source: WHO)

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

Type of trial (Data source: WHO)

Interventional clinical trial of medicinal product

Design of the trial (Data source: WHO)

Controlled: yesRandomised: yesOpen: noSingle blind: noDouble blind: yesParallel group: yesCross over: noOther: noIf controlled, specify comparator, Other Medicinial Product: yesPlacebo: noOther: noNumber of treatment arms in the trial: 2

Phase (Data source: WHO)

Human pharmacology (Phase I): noTherapeutic exploratory (Phase II): noTherapeutic confirmatory - (Phase III): yesTherapeutic use (Phase IV): no

Primary end point (Data source: WHO)

Main Objective: The primary objective of this study is to compare LCZ696 to valsartan in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure (HF) hospitalizations, in HF patients (NYHA Class II-IV) with preserved EF (LVEF =45%). The treatment arm with the lower rate of events will be deemed as having a successful response.;Secondary Objective: - Evaluation of the composite endpoint of CV death, total HF hospitalizations, total strokes, and total MIs. The treatment arm with the lower rate of events will be deemed a successful response.
- Evaluation of change from baseline to Month 8 in NYHA functional class, a well established grading
scale used to classify a HF patients' level of functionality based on the signs and symptoms of HF exhibited by the patient.
- Evaluation of the time to onset of atrial fibrillation (AF) in patients wtihout prior AF (no prior history of AF and no AF at baseline).
- Evaluation of the time to all cause death.;Primary end point(s): Cumulative number of primary composite events of cardiovascular (CV) death and total (first and recurrent) HF hospitalizations.;Timepoint(s) of evaluation of this end point: Total follow up time (up to 57 months)

Secundary end point (Data source: WHO)

Secondary end point(s): - Cumulative number of events of the extended composite endpoint of CV death, total HF hospitalizations, total non-fatal strokes, and total non-fatal myocardial infarctions (MIs).
- Change from baseline to Month 8 in New York Heart Association (NYHA) functional class.
- Time to new onset of atrial fibrillation (AF).
- Time to all-cause mortality.;Timepoint(s) of evaluation of this end point: - Total follow up time (up to 57 months).
- 8 months for the NYHA functional class.

Contact information (Data source: WHO)

Novartis Pharma Services AG

Trial results (Data source: WHO)

Results summary

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

Link to the results in the primary register

https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-001747-31/results

Information on the availability of individual participant data

no information available yet

Trial sites

Countries (Data source: WHO)

Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Democratic People's Republic of, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, Israel, Italy, Japan, Korea, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States

Contact for further information on the trial

Contact for general information (Data source: WHO)

Drug Regulatory Affairs
Largo Umberto Boccioni, 1
NOVARTIS FARMA S.p.A.
+390296541
info.studiclinici@novartis.com

Contact for scientific information (Data source: WHO)

Drug Regulatory Affairs
Largo Umberto Boccioni, 1
NOVARTIS FARMA S.p.A.
+390296541
info.studiclinici@novartis.com

Further trial identification numbers

Secondary ID (Data source: WHO)

CLCZ696D2301
2013-001747-31-SK
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