COmparing arNi and Ace For Improving Erectile Dysfunction in mEN With reduCed Ejection Fraction Heart Failure
NCT ID: NCT03917459
Last Updated: 2024-02-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
27 participants
INTERVENTIONAL
2019-04-16
2021-05-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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LCZ696
LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid)
LCZ696
sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
LCZ696 matching placebo
Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Enalapril
Enalapril 10 mg
Enalapril matching placebo
Placebo to Enalapril 10 mg film-coated tablets
Enalapril
Enalapril 10 mg film-coated tablets
Interventions
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LCZ696
sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Enalapril matching placebo
Placebo to Enalapril 10 mg film-coated tablets
Enalapril
Enalapril 10 mg film-coated tablets
LCZ696 matching placebo
Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
MALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Novartis Investigative Site
Hanover, Lower Saxony, Germany
Novartis Investigative Site
Bamberg, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Böhlen, , Germany
Novartis Investigative Site
Buchholz in der Nordheide, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Jerichow, , Germany
Novartis Investigative Site
Markkleeberg, , Germany
Novartis Investigative Site
Nuremberg, , Germany
Novartis Investigative Site
Rostock, , Germany
Novartis Investigative Site
Ulm, , Germany
Novartis Investigative Site
Wermsdorf, , Germany
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Plain Language Trial Summary
Other Identifiers
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2018-000220-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLCZ696BDE03
Identifier Type: -
Identifier Source: org_study_id
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