COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure

A Randomized, Double-blind, Active-controlled Study to Assess the Effect of Sacubitril/Valsartan Compared With Enalapril to Improve Erectile Function in Patients With Heart Failure With Reduced Ejection Fraction and Erectile Dysfunction

ClinicalTrials.gov Identifier: NCT03917459

Novartis Reference Number: CLCZ696BDE03

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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

The purpose of this study is to determine the effect of LCZ696 vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction

Condition 
Heart Failure
Heart Failure, Systolic
Erectile Dysfunction
Phase 
Phase 3
Overall status 
Recruiting
Enrollment count 
200 participants
Start date 
Apr 16, 2019
Completion date 
Mar 15, 2022
Gender 
Male
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Drug
LCZ696
LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Drug
Enalapril matching placebo
Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
Drug
Enalapril
Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
Drug
LCZ696 matching placebo
Placebo to LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tabletsLCZ696 50 mg, 100 mg and 200 mg

Eligibility Criteria

Key Inclusion Criteria:

Patients with a diagnosis of chronic heart failure (NYHA class II) and reduced ejection fraction (LVEF < 40%)
Patients must be living in a stable and sexually active heterosexual partnership for at least 6 months prior study start
Patients must have a mild to moderate erectile dysfunction (determined by using the IIEF-5 questionnaire)
Patients must be on an ACEI or an ARB at a stable dose for at least 4 weeks prior study start
Patients must be literate in German

Key Exclusion Criteria:

History of hypersensitivity to any of the study drugs or its excipients or to drugs of similar chemical classes, ACEIs, ARBs or NEP inhibitors, as well as known or suspected contraindications to the study drugs
Previous history of intolerance to recommended target doses of ACEIs or ARBs
Known history of angioedema
Current acute decompensated HF (exacerbation of chronic HF manifested by signs and symptoms that may require intravenous therapy)
Symptomatic hypotension
Impaired renal function
Penile anatomical defects and Peyronie's disease
Diabetes mellitus Type I or insulin-dependent Type II
Known prostate cancer

Other protocol-defined inclusion/exclusion criteria may apply.

Study Locations

Germany
Novartis Investigative Site
Recruiting
Hannover, 30159
Niedersachsen
Germany
Novartis Investigative Site
Recruiting
Bad Homburg, 61348
-
Germany
Novartis Investigative Site
Recruiting
Bamberg, 96049
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10117
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10367
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10629
-
Germany
Novartis Investigative Site
Recruiting
Berlin, 10789
-
Germany
Novartis Investigative Site
Withdrawn
Berlin, 12157
-
Germany
Novartis Investigative Site
Completed
Berlin, 13353
-
Germany
Novartis Investigative Site
Recruiting
Berlin, D 10559
-
Germany
Novartis Investigative Site
Recruiting
Boehlen, 04564
-
Germany
Novartis Investigative Site
Recruiting
Buchholz in der Nordheide, 21244
-
Germany
Novartis Investigative Site
Recruiting
Deggingen, 73326
-
Germany
Novartis Investigative Site
Recruiting
Frankfurt, 60594
-
Germany
Novartis Investigative Site
Recruiting
Halle Saale, 06120
-
Germany
Novartis Investigative Site
Recruiting
Homburg, 66421
-
Germany
Novartis Investigative Site
Recruiting
Jerichow, 39319
-
Germany
Novartis Investigative Site
Recruiting
Karlsruhe, 76137
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 51065
-
Germany
Novartis Investigative Site
Recruiting
Koeln, 51069
-
Germany
Novartis Investigative Site
Recruiting
Leipzig, 04109
-
Germany
Novartis Investigative Site
Recruiting
Mainz, 55131
-
Germany
Novartis Investigative Site
Withdrawn
Mannheim, 68161
-
Germany
Novartis Investigative Site
Recruiting
Markkleeberg, 04416
-
Germany
Novartis Investigative Site
Recruiting
Muehldorf Am Inn, 84453
-
Germany
Novartis Investigative Site
Recruiting
Nuremberg, 90402
-
Germany
Novartis Investigative Site
Recruiting
Reinfeld, 23858
-
Germany
Novartis Investigative Site
Recruiting
Rostock, 18107
-
Germany
Novartis Investigative Site
Recruiting
Stadtlohn, 48703
-
Germany
Novartis Investigative Site
Withdrawn
Straubing, 94315
-
Germany
Novartis Investigative Site
Recruiting
Ulm, 89077
-
Germany
Novartis Investigative Site
Recruiting
Wallerfing, 94574
-
Germany
Novartis Investigative Site
Recruiting
Wermsdorf, 04779
-
Germany

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Name: 
Novartis Pharmaceuticals
Phone: 
Email: 

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Call 1-999-669-6682 or email [email protected]