NCT02768298 - Exercise Capacity Study of LCZ696 vs. Enalapril in Patients With Chronic Heart Failure and Reduced Ejection Fraction. | Biotech Hunter

Enrollment

201

Participants

Timeline

Start Date

July 12, 2016

Primary Completion Date

November 25, 2019

Study Completion Date

November 25, 2019

Conditions

Chronic Heart Failure With Reduced Ejection Fraction

Interventions

DRUG

LCZ696

LCZ696 100 mg bid for 2 weeks followed by LCZ696 200 mg bid for 10 weeks. Treatment was administered as oral tablets.

DRUG

Enalapril

"Enalapril 5 mg bid for 2 weeks followed by enalapril 10 mg bid for 10 weeks. Treatment was administered as oral tablets.~Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid."

DRUG

Placebo matching enalapril

Patients randomized to LCZ696 arm also received placebo matching enalapril (enalapril 0 mg tablets) to ensure the blinding during the entire course of the study.

DRUG

Placebo matching LCZ696

Patients randomized to enalapril arm also received placebo matching LCZ696 (LCZ696 0 mg tablets) to ensure the blinding during the entire course of the study.

Trial Locations (34)

10787

Novartis Investigative Site, Berlin

13055

Novartis Investigative Site, Berlin

13353

Novartis Investigative Site, Berlin

13405

Novartis Investigative Site, Berlin

15562

Novartis Investigative Site, Rüdersdorf

22291

Novartis Investigative Site, Hamburg

24105

Novartis Investigative Site, Kiel

31582

Novartis Investigative Site, Nienburg

36199

Novartis Investigative Site, Rotenburg an der Fulda

37075

Novartis Investigative Site, Göttingen

42117

Novartis Investigative Site, Wuppertal

50733

Novartis Investigative Site, Koeln-Nippes

50937

Novartis Investigative Site, Cologne

51065

Novartis Investigative Site, Cologne

51375

Novartis Investigative Site, Leverkusen

53115

Novartis Investigative Site, Bonn

56068

Novartis Investigative Site, Koblenz

56564

Novartis Investigative Site, Neuwied

57072

Novartis Investigative Site, Siegen

60389

Novartis Investigative Site, Frankfurt

67063

Novartis Investigative Site, Ludwigshafen

67550

Novartis Investigative Site, Worms

69115

Novartis Investigative Site, Heidelberg

71634

Novartis Investigative Site, Ludwigsburg

78052

Novartis Investigative Site, Villingen-Schwenningen

79106

Novartis Investigative Site, Freiburg im Breisgau

81675

Novartis Investigative Site, München

89077

Novartis Investigative Site, Ulm

93053

Novartis Investigative Site, Regensburg

97080

Novartis Investigative Site, Würzburg

99089

Novartis Investigative Site, Erfurt

01099

Novartis Investigative Site, Dresden

01277

Novartis Investigative Site, Dresden

01307

Novartis Investigative Site, Dresden