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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000220-33 | EudraCT Number |
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The purpose of this study was to determine the effect of sacubitril/valsartan (LCZ696) vs. Enalapril on improvement in erectile function and ability in male patients with chronic heart failure with reduced ejection fraction and erectile dysfunction.
The purpose of this study was to evaluate the effect of sacubitril/valsartan in improving erectile function in male patients with chronic heart failure (NYHA II) and reduced ejection fraction (HFrEF) and erectile dysfunction (ED). Data from this study was intended to provide a thorough understanding of the impact of sacubitril/valsartan on male sexual function and therefore quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 | Experimental | LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg bid) |
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| Enalapril | Active Comparator | Enalapril 10 mg |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 | Drug | sacubitril/valsartan 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Erectile Function Score Using Index of Erectile Function (IIEF-15) | The International Index of Erectile Function (IIEF-15) was used to assess erectile function in male patients with chronic heart failure. The IIEF-15 is a patient self-reported assessment of erectile dysfunction (ED) and consists of 15 questions assessing different aspects associated with ED. The domain evaluating erectile function consists of items 1, 2, 3, 4, 5 & 15 and its total score was used here. Total score range =1-30. Items 1-5 is 6-point Likert-type scale from '0' (= No sexual activity), '1' (=Almost never or never) to '5' (= Almost always or always). Items 15 is 5-point Likert-type scale from '1' (= very low) to '5 '(= very high). Higher score indicates better outcome | Week 12 (3 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week | Assessment of early-onset effect and end of study effect, regarding improvement in sexual activity, using patient's self-reported frequency of sexual activity per week. Patient was asked to complete a diary assessing sexual activity on a weekly basis | Baseline, Week 4, Week 12 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Hanover | Lower Saxony | 30159 | Germany | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Plain Language Trial Summary | View source |
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Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 13 patients were randomized to the LCZ696 group and 14 patients were randomized to the enalapril group. Of these, 12 patients in the LCZ696 group and 13 patients in the enalapril group completed the study. One patient from the LCZ696 group discontinued due to Adverse Event and 1 patient from the enalapril group discontinued due to subject decision.
A total of 13 patients were randomized to the LCZ696 group and 14 patients were randomized to the enalapril group. Of these, 12 patients in the LCZ696 group and 13 patients in the enalapril group completed the study. One patient from the LCZ696 group discontinued due to Adverse Event and 1 patient from the enalapril group discontinued due to subject decision.
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| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 | LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid |
| FG001 | Enalapril | Enalapril 10 mg bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 15, 2019 | May 19, 2022 |
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| Enalapril matching placebo | Drug | Placebo to Enalapril 10 mg film-coated tablets |
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| Enalapril | Drug | Enalapril 10 mg film-coated tablets |
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| LCZ696 matching placebo | Drug | Placebo to LCZ696 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets |
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| Summary of Change From Baseline in NT-proBNP Levels | Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12 | Baseline, Week 4, Week 12 |
| Bamberg |
| 96049 |
| Germany |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Berlin | 10789 | Germany |
| Novartis Investigative Site | Böhlen | 04564 | Germany |
| Novartis Investigative Site | Buchholz in der Nordheide | 21244 | Germany |
| Novartis Investigative Site | Frankfurt | 60594 | Germany |
| Novartis Investigative Site | Jerichow | 39319 | Germany |
| Novartis Investigative Site | Markkleeberg | 04416 | Germany |
| Novartis Investigative Site | Nuremberg | 90402 | Germany |
| Novartis Investigative Site | Rostock | 18107 | Germany |
| Novartis Investigative Site | Ulm | 89077 | Germany |
| Novartis Investigative Site | Wermsdorf | 04779 | Germany |
| COMPLETED |
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| NOT COMPLETED |
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A total of 27 patients were included in the Full Analysis Set (FAS) and safety set.
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| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 | LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid |
| BG001 | Enalapril | Enalapril 10 mg bid |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Gender | Count of Participants | Participants |
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| Race (NIH/OMB) | Race | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Erectile Function Score Using Index of Erectile Function (IIEF-15) | The International Index of Erectile Function (IIEF-15) was used to assess erectile function in male patients with chronic heart failure. The IIEF-15 is a patient self-reported assessment of erectile dysfunction (ED) and consists of 15 questions assessing different aspects associated with ED. The domain evaluating erectile function consists of items 1, 2, 3, 4, 5 & 15 and its total score was used here. Total score range =1-30. Items 1-5 is 6-point Likert-type scale from '0' (= No sexual activity), '1' (=Almost never or never) to '5' (= Almost always or always). Items 15 is 5-point Likert-type scale from '1' (= very low) to '5 '(= very high). Higher score indicates better outcome | All participants who received at least one dose of study treatment and had a valid assessment of the outcome measure | Posted | Least Squares Mean | Standard Error | Scores on a scale | Week 12 (3 months) |
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| Secondary | Summary of Change From Baseline in Self-reported Frequency of Sexual Activity Per Week | Assessment of early-onset effect and end of study effect, regarding improvement in sexual activity, using patient's self-reported frequency of sexual activity per week. Patient was asked to complete a diary assessing sexual activity on a weekly basis | Full Analysis Set, including all participants who received at least one dose of study treatment | Posted | Mean | Standard Deviation | Activities per week. | Baseline, Week 4, Week 12 |
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| Secondary | Summary of Change From Baseline in NT-proBNP Levels | Change in n-terminal prohormone of brain natriuretic peptide (NT-proBNP) levels compared to baseline assessed at Week 4 and Week 12 | Full Analysis Set, including all participants who received at least one dose of study treatment | Posted | Median | Inter-Quartile Range | pg/mL | Baseline, Week 4, Week 12 |
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Adverse Events were collected from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 2 years, 1 month
Any sign or symptom that occurs during the study treatment plus the 30 days post treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCZ696 | LCZ696 200 mg (sacubitril/valsartan 97 mg/103 mg) bid | 0 | 13 | 1 | 13 | 7 | 13 |
| EG001 | Enalapril | Enalapril 10 mg bid | 0 | 14 | 1 | 14 | 5 | 14 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA (24.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA (24.0) | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA (24.0) | Systematic Assessment |
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| Blood potassium decreased | Investigations | MedDRA (24.0) | Systematic Assessment |
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| Fluid retention | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
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| Gout | Metabolism and nutrition disorders | MedDRA (24.0) | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (24.0) | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (24.0) | Systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA (24.0) | Systematic Assessment |
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The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 6, 2021 | May 19, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D054143 | Heart Failure, Systolic |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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