A Randomized, Double-blind Controlled Study Comparing LCZ696 to Medical Therapy for Comorbidities in HFpEF Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

2,572

Participants

Timeline

Start Date

August 22, 2017

Primary Completion Date

October 28, 2019

Study Completion Date

October 28, 2019

Conditions
Heart Failure With Preserved Ejection Fraction
Interventions
DRUG

sacubitril/valsartan

Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally

DRUG

Enalapril

Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally

DRUG

Valsartan

Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally

DRUG

Placebo to match sacubitril/valsartan

Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally

DRUG

Placebo to match enalapril

Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally

DRUG

Placebo to match valsartan

Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally

Trial Locations (380)

11

Novartis Investigative Site, Jesus Maria

27

Novartis Investigative Site, San Isidro

32

Novartis Investigative Site, San Miguel

41

Novartis Investigative Site, San Borja

1012

Novartis Investigative Site, Riga

1085

Novartis Investigative Site, Budapest

1134

Novartis Investigative Site, Budapest

1145

Novartis Investigative Site, Budapest

1233

Novartis Investigative Site, Sofia

1431

Novartis Investigative Site, Sofia

1527

Novartis Investigative Site, Sofia

1606

Novartis Investigative Site, Sofia

2300

Novartis Investigative Site, Pernik

2650

Novartis Investigative Site, Hvidovre

3080

Novartis Investigative Site, Santa Fe

3401

Novartis Investigative Site, Liepāja

3550

Novartis Investigative Site, Heusden-Zolder

3600

Novartis Investigative Site, Genk

4000

Novartis Investigative Site, Plovdiv

4002

Novartis Investigative Site, Plovdiv

4010

Novartis Investigative Site, Linz

4400

Novartis Investigative Site, Pazardzhik

4500

Novartis Investigative Site, Huy

5000

Novartis Investigative Site, Veliko Tarnovo

5001

Novartis Investigative Site, Ogre

5020

Novartis Investigative Site, Salzburg

5800

Novartis Investigative Site, Pleven

6060

Novartis Investigative Site, Hall in Tirol

6720

Novartis Investigative Site, Szeged

8018

Novartis Investigative Site, Burgas

8500

Novartis Investigative Site, Kortrijk

8930

Novartis Investigative Site, Randers

9000

Novartis Investigative Site, Ghent

9200

Novartis Investigative Site, Mosanmagyarovar

9700

Novartis Investigative Site, Shumen

10138

Novartis Investigative Site, Tallinn

10330

Novartis Investigative Site, Bangkok

10400

Novartis Investigative Site, Bangkok

10700

Novartis Investigative Site, Bangkok

10787

Novartis Investigative Site, Berlin

10789

Novartis Investigative Site, Berlin

11510

Novartis Investigative Site, Puerto Real

11650

Novartis Investigative Site, Villamartín

12157

Novartis Investigative Site, Berlin

12683

Novartis Investigative Site, Berlin

13008

Novartis Investigative Site, Marseille

13125

Novartis Investigative Site, Buch

13347

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

13419

Novartis Investigative Site, Tallinn

14004

Novartis Investigative Site, Córdoba

14471

Novartis Investigative Site, Potsdam

14621

Novartis Investigative Site, Rochester

15006

Novartis Investigative Site, A Coruña

16816

Novartis Investigative Site, Neuruppin

18000

Novartis Investigative Site, Niš

18107

Novartis Investigative Site, Rostock

18205

Novartis Investigative Site, Niška Banja

19001

Novartis Investigative Site, Abington

19412

Novartis Investigative Site, Brüel

20025

Novartis Investigative Site, Legnano

20099

Novartis Investigative Site, Sesto San Giovanni

20132

Novartis Investigative Site, Milan

20162

Novartis Investigative Site, Milan

21005

Novartis Investigative Site, Huelva

21075

Novartis Investigative Site, Hamburg

21204

Novartis Investigative Site, Kamenitz

21339

Novartis Investigative Site, Lüneburg

22042

Novartis Investigative Site, Falls Church

22880

Novartis Investigative Site, Wedel

23538

Novartis Investigative Site, Lübeck

23966

Novartis Investigative Site, Wismar

24105

Novartis Investigative Site, Kiel

24127

Novartis Investigative Site, Bergamo

25030

Novartis Investigative Site, Besançon

25198

Novartis Investigative Site, Lleida

26480

Novartis Investigative Site, Eskişehir

26871

Novartis Investigative Site, Papenburg

28040

Novartis Investigative Site, Madrid

28630

Novartis Investigative Site, Le Coudray

28702

Novartis Investigative Site, San Sebastián de los Reyes

29010

Novartis Investigative Site, Málaga

30100

Novartis Investigative Site, Pilsen

30120

Novartis Investigative Site, El Palmar

31582

Novartis Investigative Site, Nienburg

31792

Novartis Investigative Site, Thomasville

32127

Novartis Investigative Site, Port Orange

32545

Novartis Investigative Site, Bad Oeynhausen

32608

Novartis Investigative Site, Gainesville

32756

Novartis Investigative Site, Detmold

33133

Novartis Investigative Site, Miami

33312

Novartis Investigative Site, Hollywood

33343

Novartis Investigative Site, Mersin

33604

Novartis Investigative Site, Bielefeld

34000

Novartis Investigative Site, Kragujevac

Novartis Investigative Site, Ubon Ratchathani

34209

Novartis Investigative Site, Bradenton

34304

Novartis Investigative Site, Istanbul

34662

Novartis Investigative Site, Istanbul

35010

Novartis Investigative Site, Las Palmas de Gran Canarias

35033

Novartis Investigative Site, Rennes

35040

Novartis Investigative Site, Izmir

35340

Novartis Investigative Site, Izmir

36037

Novartis Investigative Site, Fulda

36199

Novartis Investigative Site, Rotenburg an der Fulda

36420

Novartis Investigative Site, Andalusia

36608

Novartis Investigative Site, Mobile

37170

Novartis Investigative Site, Chambray-lès-Tours

38039

Novartis Investigative Site, Talas / Kayseri

38301

Novartis Investigative Site, Jackson

39003

Novartis Investigative Site, Tábor

40002

Novartis Investigative Site, Khon Kaen

40138

Novartis Investigative Site, Bologna

41014

Novartis Investigative Site, Seville

41380

Novartis Investigative Site, Kocaeli

43302

Novartis Investigative Site, Marion

44137

Novartis Investigative Site, Dortmund

44200

Novartis Investigative Site, Guadalajara

44379

Novartis Investigative Site, Dortmund

44670

Novartis Investigative Site, Guadalajara

44866

Novartis Investigative Site, Wattenscheid

45100

Novartis Investigative Site, Rovigo

45138

Novartis Investigative Site, Essen

45277

Novartis Investigative Site, Essen

46010

Novartis Investigative Site, Valencia

46026

Novartis Investigative Site, Valencia

46063

Novartis Investigative Site, Liberec

46940

Novartis Investigative Site, Manises

47144

Novartis Investigative Site, Kaunas

48149

Novartis Investigative Site, Münster

48703

Novartis Investigative Site, Stadtlohn

50733

Novartis Investigative Site, Koeln-Nippes

51014

Novartis Investigative Site, Tartu

52044

Novartis Investigative Site, Cortona

55116

Novartis Investigative Site, Mainz

57072

Novartis Investigative Site, Siegen

57104

Novartis Investigative Site, Sioux Falls

57201

Novartis Investigative Site, Policska

58140

Novartis Investigative Site, Sivas

58633

Novartis Investigative Site, Jihlava

59200

Novartis Investigative Site, Tourcoing

59300

Novartis Investigative Site, Valenciennes

60004

Novartis Investigative Site, Arlington Heights

60200

Novartis Investigative Site, Brno

60594

Novartis Investigative Site, Frankfurt

61348

Novartis Investigative Site, Bad Homburg

63110

Novartis Investigative Site, Rodgau

65000

Novartis Investigative Site, Muang

65428

Novartis Investigative Site, Rüsselsheim am Main

65929

Novartis Investigative Site, Frankfurt

67067

Novartis Investigative Site, Ludwigshafen

67071

Novartis Investigative Site, Ludwigshafen

67454

Novartis Investigative Site, Haßloch

68114

Novartis Investigative Site, Omaha

68165

Novartis Investigative Site, Mannheim

68526

Novartis Investigative Site, Lincoln

70043

Novartis Investigative Site, Chalmette

70360

Novartis Investigative Site, Houma

71301

Novartis Investigative Site, Alexandria

74523

Novartis Investigative Site, Schwäbisch Hall

75234

Novartis Investigative Site, Dallas

75742

Novartis Investigative Site, Valašské Meziříčí

75904

Novartis Investigative Site, Lufkin

76000

Novartis Investigative Site, Querétaro

76100

Novartis Investigative Site, Rehovot

77375

Novartis Investigative Site, Tomball

77900

Novartis Investigative Site, Olomouc Lazce

78200

Novartis Investigative Site, San Luis Potosí City

78278

Novartis Investigative Site, Ashkelon

80045

Novartis Investigative Site, Aurora

80638

Novartis Investigative Site, Munich

81108

Novartis Investigative Site, Bratislava

84101

Novartis Investigative Site, Beersheba

84453

Novartis Investigative Site, Mühldorf

87042

Novartis Investigative Site, Limoges

89077

Novartis Investigative Site, Ulm

89081

Novartis Investigative Site, Ulm

90127

Novartis Investigative Site, Palermo

90211

Novartis Investigative Site, Beverly Hills

90402

Novartis Investigative Site, Nuremberg

90766

Novartis Investigative Site, Fürth

90813

Novartis Investigative Site, Long Beach

91100

Novartis Investigative Site, Corbeil-Essonnes

91342

Novartis Investigative Site, Sylmar

91701

Novartis Investigative Site, Trnava

92704

Novartis Investigative Site, Santa Ana

93053

Novartis Investigative Site, Regensburg

94002

Novartis Investigative Site, Nové Zámky

94275

Novartis Investigative Site, Le Kremlin-Bicêtre

94574

Novartis Investigative Site, Wallerfing

96049

Novartis Investigative Site, Bamberg

96450

Novartis Investigative Site, Coburg

97080

Novartis Investigative Site, Würzburg

97251

Novartis Investigative Site, Handlová

97330

Novartis Investigative Site, Corvallis

98122

Novartis Investigative Site, Seattle

98439

Novartis Investigative Site, Lučenec

99097

Novartis Investigative Site, Erfurt

101953

Novartis Investigative Site, Moscow

110007

Novartis Investigative Site, New Delhi

110084

Novartis Investigative Site, Piteşti

117292

Novartis Investigative Site, Moscow

117556

Novartis Investigative Site, Moscow

121309

Novartis Investigative Site, Moscow

129301

Novartis Investigative Site, Moscow

130095

Novartis Investigative Site, Târgovişte

150047

Novartis Investigative Site, Yaroslavl

153012

Novartis Investigative Site, Ivanovo

188300

Novartis Investigative Site, Gatchina

191015

Novartis Investigative Site, Saint Petersburg

191144

Novartis Investigative Site, Saint Petersburg

196601

Novartis Investigative Site, Saint Petersburg

197376

Novartis Investigative Site, Saint Petersburg

199106

Novartis Investigative Site, Saint Petersburg

200642

Novartis Investigative Site, Craiova

200931

Novartis Investigative Site, Craiova

226003

Novartis Investigative Site, Lucknow

300041

Novartis Investigative Site, Timișoara

300362

Novartis Investigative Site, Timișoara

300736

Novartis Investigative Site, Timișoara

334003

Novartis Investigative Site, Bikaner

344022

Novartis Investigative Site, Rostov-on-Don

344068

Novartis Investigative Site, Rostov-on-Don

390022

Novartis Investigative Site, Vadodara

410012

Novartis Investigative Site, Saratov

422005

Novartis Investigative Site, Nashik

422007

Novartis Investigative Site, Nashik

430123

Novartis Investigative Site, Baia Mare

440009

Novartis Investigative Site, Nagpur

540142

Novartis Investigative Site, Târgu Mureş

540143

Novartis Investigative Site, Târgu Mureş

560040

Novartis Investigative Site, India

576104

Novartis Investigative Site, Manipal

600114

Novartis Investigative Site, Bacau

603126

Novartis Investigative Site, Nizhny Novgorod

614097

Novartis Investigative Site, Perm

620028

Novartis Investigative Site, Yekaterinburg

620109

Novartis Investigative Site, Yekaterinburg

625026

Novartis Investigative Site, Tyumen

684031

Novartis Investigative Site, San Gil

760001

Novartis Investigative Site, Santiago de Cali

1600190

Novartis Investigative Site, Lisbon

4204179

Novartis Investigative Site, Bucharest

4710243

Novartis Investigative Site, Braga

4901858

Novartis Investigative Site, Viana do Castelo

4941492

Novartis Investigative Site, Petah Tikva

06905

Novartis Investigative Site, Stamford

02114

Novartis Investigative Site, Boston

C1280AEB

Novartis Investigative Site, Caba

B1878GEG

Novartis Investigative Site, Quilmes

N3300AHX

Novartis Investigative Site, Posadas

A4406BPF

Novartis Investigative Site, Salta

T4000ICL

Novartis Investigative Site, San Miguel de Tucumán

S2000DSV

Novartis Investigative Site, Rosario

T4000IFL

Novartis Investigative Site, San Miguel de Tucumán

C1430EGF

Novartis Investigative Site, Buenos Aires

X5000AAW

Novartis Investigative Site, Córdoba

X5000EVQ

Novartis Investigative Site, Córdoba

X5000

Novartis Investigative Site, Córdoba

X5004BAL

Novartis Investigative Site, Córdoba

X5006CBI

Novartis Investigative Site, Córdoba

P3600

Novartis Investigative Site, Formosa

D5702JRS

Novartis Investigative Site, San Luis

S2200

Novartis Investigative Site, Santa Fe

S3000FWO

Novartis Investigative Site, Santa Fe

A5280

Novartis Investigative Site, Braunau am Inn

A-8036

Novartis Investigative Site, Graz

60430 370

Novartis Investigative Site, Fortaleza

74223-130

Novartis Investigative Site, Goiânia

74605 050

Novartis Investigative Site, Goiânia

30140 062

Novartis Investigative Site, Belo Horizonte

30150-221

Novartis Investigative Site, Belo Horizonte

80230 130

Novartis Investigative Site, Curitiba

92425 900

Novartis Investigative Site, Canoas

90880-480

Novartis Investigative Site, Porto Alegre

89010 500

Novartis Investigative Site, Blumenau

13060 080

Novartis Investigative Site, Campinas

14048-900

Novartis Investigative Site, Ribeirão Preto

15015-750

Novartis Investigative Site, São José do Rio Preto

15090-000

Novartis Investigative Site, São José do Rio Preto

E1G 1A7

Novartis Investigative Site, Moncton

L8L 2X2

Novartis Investigative Site, Hamilton

L6K 3W7

Novartis Investigative Site, Oakville

H1T 1C8

Novartis Investigative Site, Montreal

G5Y 4T8

Novartis Investigative Site, St-Georges Beauce

050036

Novartis Investigative Site, Medellín

080020

Novartis Investigative Site, Barranquilla

Unknown

Novartis Investigative Site, Barranquilla

Novartis Investigative Site, Montería

Novartis Investigative Site, Louny

Novartis Investigative Site, Hadera

Novartis Investigative Site, Cona

Novartis Investigative Site, San Vito al Tagliamento

Novartis Investigative Site, Trujillo

Novartis Investigative Site, Bursa

250 01

Novartis Investigative Site, Brandýs nad Labem

381 01

Novartis Investigative Site, Český Krumlov

466 60

Novartis Investigative Site, Jablonec nad Nisou

767 55

Novartis Investigative Site, Kroměříž

532 03

Novartis Investigative Site, Pardubice

568 25

Novartis Investigative Site, Svitavy

674 01

Novartis Investigative Site, Třebíč

280 20

Novartis Investigative Site, Kolín

751 52

Novartis Investigative Site, Přerov

DK-2400

Novartis Investigative Site, Copenhagen NV

01099

Novartis Investigative Site, Dresden

D 10559

Novartis Investigative Site, Berlin

09130

Novartis Investigative Site, Chemnitz

D-51065

Novartis Investigative Site, Cologne

01069

Novartis Investigative Site, Dresden

01277

Novartis Investigative Site, Dresden

01307

Novartis Investigative Site, Dresden

04910

Novartis Investigative Site, Elsterwerda

06120

Novartis Investigative Site, Halle

07740

Novartis Investigative Site, Jena

04103

Novartis Investigative Site, Leipzig

01589

Novartis Investigative Site, Riesa

01001

Novartis Investigative Site, Guatemala City

01010

Novartis Investigative Site, Guatemala City

01011

Novartis Investigative Site, Guatemala City

01015

Novartis Investigative Site, Guatemala City

380 060

Novartis Investigative Site, Ahmedabad

110 060

Novartis Investigative Site, New Delhi

310 9601

Novartis Investigative Site, Haifa

07100

Novartis Investigative Site, Sassari

LV-5417

Novartis Investigative Site, Daugavpils

LT 50161

Novartis Investigative Site, Kaunas

LT-08661

Novartis Investigative Site, Vilnius

7609 PP

Novartis Investigative Site, Almelo

1091AC

Novartis Investigative Site, Amsterdam

7416 SE

Novartis Investigative Site, Deventer

7009 BL

Novartis Investigative Site, Doetinchem

2803 HH

Novartis Investigative Site, Gouda

9713 GZ

Novartis Investigative Site, Groningen

7770 AA

Novartis Investigative Site, Hardenberg

6500 HB

Novartis Investigative Site, Nijmegen

9501 HE

Novartis Investigative Site, Stadskanaal

5022 GC

Novartis Investigative Site, Tilburg

5912 BL

Novartis Investigative Site, Venlo

01

Novartis Investigative Site, Lima Cercado

CALLAO 2

Novartis Investigative Site, Callao

1495 005

Novartis Investigative Site, Lisbon

1500 650

Novartis Investigative Site, Lisbon

4564-007

Novartis Investigative Site, Penafiel

4099-001

Novartis Investigative Site, Porto

5000-508

Novartis Investigative Site, Vila Real

021659

Novartis Investigative Site, Bucharest

022328

Novartis Investigative Site, Bucharest

062272

Novartis Investigative Site, Bucharest

11 000

Novartis Investigative Site, Belgrade

02901

Novartis Investigative Site, Námestovo

080 01

Novartis Investigative Site, Prešov

085 01

Novartis Investigative Site, Bardejov

08501

Novartis Investigative Site, Bardejov

821 07

Novartis Investigative Site, Bratislava

842 31

Novartis Investigative Site, Bratislava

026 01

Novartis Investigative Site, Dolný Kubín

040 01

Novartis Investigative Site, Košice

045 01

Novartis Investigative Site, Moldava nad Bodvou

949 01

Novartis Investigative Site, Nitra

940 01

Novartis Investigative Site, Nové Zámky

01701

Novartis Investigative Site, Považská Bystrica

08001

Novartis Investigative Site, Prešov

09601

Novartis Investigative Site, Snina

089 01

Novartis Investigative Site, Svidník

03186

Novartis Investigative Site, Torrevieja (Alicante)

03700

Novartis Investigative Site, Alicante

01160

Novartis Investigative Site, Adana

06490

Novartis Investigative Site, Ankara

07070

Novartis Investigative Site, Antalya

09100

Novartis Investigative Site, Aydin

HP11 2TT

Novartis Investigative Site, High Wycombe

TS19 8PE

Novartis Investigative Site, Stockton-on-Tees

S44 5BL

Novartis Investigative Site, Chesterfield

BT63 5QQ

Novartis Investigative Site, Craigavon

PE8 6PL

Novartis Investigative Site, Wansford

KT15 2BH

Novartis Investigative Site, Addlestone

SR4 7TP

Novartis Investigative Site, Sunderland

LS1 3EX

Novartis Investigative Site, Leeds

YO31 8HE

Novartis Investigative Site, York

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY