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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003085-32 | EudraCT Number |
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The purpose of this randomized, actively controlled, double-blind study with prospective data collection was to assess differences between sacubitril/valsartan versus enalapril in increasing exercise capacity and non-sedentary physical activity in HFrEF patients. Physical activity was assessed by the 6 minute walk test, and daily physical activity was continuously measured by means of a wrist-worn accelerometry device from 2 weeks before until 12 weeks after start of study therapy (sacubitril/valsartan or enalapril).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LCZ696 (Sacubitril/Valsartan) | Experimental | After randomization, patients in this arm received LCZ696 (Sacubitril/Valsartan) twice daily and matching placebo of Enalapril depending on the patient's previous ACEI/ARB dose (enalapril equivalent dose) for 2 weeks. Patients could start study medication at dose level 1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ) or matching placebo bid. After 2 weeks (visit 3) the doses were up-titrated: patients, who started on dose level 2 or 2a received the target dose of study medication (level 3) at this point. After another 2 weeks (visit 4) all patients were to achieve the target dose of 97 mg/103 mg bid LCZ696(sacubitril/valsartan) and matching placebo, provided no safety and tolerability issues arised during uptitration. |
|
| Enalapril | Active Comparator | After randomization, patients in this arm received Enalapril twice daily and matching placebo of LCZ696 (Sacubitril/Valsartan) depending on the patient's previous ACEI/ARB for 2 weeks. Patients could start study medication at dose level 1 or 2a or matching placebo bid. After 2 weeks (visit 3) the doses were up-titrated: patients, who started on dose level 2 or 2a received the target dose of study medication (level 3) at this point. After another 2 weeks (visit 4) all patients were to achieve the target dose of 10 mg bid enalapril and matching placebo, provided no safety and tolerability issues arised during uptitration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCZ696 (Sacubitril/Valsartan) | Drug | LCZ696 (sacubitril/valsartan) was available in 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at End of Study (Week 12) | The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at 12 weeks. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. | Baseline, Week 12 |
| Change From Baseline (Week 0) in Mean Daily Non-sedentary Daytime Activity at End of Study (Week 12) | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity is being calculated over 14 days before randomization (baseline i.e. week -2 to week 0) and the last 14 days of treatment (i.e. week 10 to week 12). | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group. | Baseline, Week 12 |
| Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS Subset Without AE/SAE |
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Key Inclusion Criteria:
AND one of the following two criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Edegem | Antwerpen | 2650 | Belgium | ||
| Novartis Investigative Site |
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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It was planned to recruit 300 patients per treatment arm, i.e. 600 patients in total. A total of 764 patients were screened, of whom 621 patients were randomized (310 in the sacubitril/valsartan group and 311 in the enalapril group).
This study was conducted at 120 centers in 19 countries worldwide (Belgium, Bulgaria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Iceland, Ireland, Latvia, Lithuania, Netherlands, Norway, Poland, Spain, Sweden and UK).
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| ID | Title | Description |
|---|---|---|
| FG000 | LCZ696 (Sacubitril/Valsartan) | LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Randomization (Visit 2) |
|
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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 | Sep 11, 2018 | Apr 11, 2019 |
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|
| Placebo of LCZ696 (Sacubitril/Valsartan) | Drug | Placebo of LCZ696 (sacubitril/valsartan) was available to match 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets |
|
|
| Enalapril | Drug | Enalapril was available in 2.5 mg, 5 mg and 10 mg film-coated tablets |
|
| Placebo of Enalapril | Drug | Placebo of Enalapril was available to match 2.5 mg, 5 mg and 10 mg film-coated tablets |
|
|
The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group. |
| Baseline, Week 12 |
| Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters. | Baseline, Week 12 |
| Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS Subset Without AE/SAE | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters. | Baseline, Week 12 |
| Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance from 100 to 450 meters. | Baseline, Week 12 |
| Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS Subset Without AE/SAE | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance from 100 to 450 meters. | Baseline, Week 12 |
| Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at Weeks 4 and 8 | The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at Weeks 4 and 8. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. | Baseline, Week 4 and Week 8 |
| Number and Percentage of Participants Who Show Increased Levels (>= 10% Increase) of Non Sedentary Daytime Physical Activity at Week 12 Compared to Baseline | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity will be calculated over 14 days before randomization (baseline) and the last 14 days of treatment (i.e week 10 to week 12) | Baseline, Week 12 |
| Number and Percentage of Participants Achieving PGA Score at Weeks 4, 8 and 12 | The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse. | Week 4, Week 8, Week 12 |
| Number and Percentage of Participants With Improved Symptoms of Heart Failure as Assessed by Patient Global Assessment (PGA) | The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse. Patients with improved symptoms were categorized as: Improvement, Is unchanged, Gets worse or Missing. | Week 4, Week 8, Week 12 |
| Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Weekly Intervals | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over weekly and compared to before the inclusion. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Two-weekly Intervals | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over two-weekly intervals and compared to before the inclusion. | Baseline, Weeks 0 to 2, Weeks 2 to 4, Weeks 4 to 6, Weeks 6 to 8, Weeks 8 to 10, Weeks 10 to 12 |
| Change From Baseline in Mean Daily Light Non-sedentary Daytime Physical Activity | The average number of minutes per day spent in light non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and light physical activity is defined as 178.5 - 565.5 counts per minute. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Change From Baseline in Mean Daily Moderate-to-Vigorous Non-sedentary Daytime Physical Activity | The average number of minutes per day spent in moderate to vigorous non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and moderate-to-vigorous activity is defined as > 565.5 counts per minute. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Total Weekly Time Spent in Non-sedentary Daytime Physical Activity | Non-sedentary physical activity is defined as >= 178.5 activity counts per minute; The total time spent in non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Total Weekly Time Spent in Light Non-sedentary Daytime Physical Activity | Light non-sedentary daytime physical activity is defined as between 178.5 - 565.5 counts per minute; The time spent in light non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Total Weekly Time Spent in Moderate-to-Vigorous Non-sedentary Daytime Physical Activity | Moderate-to-vigorous non-sedentary physical activity is defined as > 565.5 counts per minute. The total time spent in moderate-to-vigorous non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed. | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| Change From Baseline in Peak Six Minutes of Daytime Physical Activity | The peak 6 min walk (M6min) is a parameter derived by validated algorithms of the software that are used to preprocess actigraphy data. The parameter reflected the peak 6 minutes of day time physical activity. The mean daily 6-minute walking test was being calculated over 14 day intervals. | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 12 |
| Dendermonde |
| 9200 |
| Belgium |
| Novartis Investigative Site | Geel | 2440 | Belgium |
| Novartis Investigative Site | Ghent | 9000 | Belgium |
| Novartis Investigative Site | Turnhout | 2300 | Belgium |
| Novartis Investigative Site | Pleven | 5800 | Bulgaria |
| Novartis Investigative Site | Plovdiv | 4000 | Bulgaria |
| Novartis Investigative Site | Sofia | 1233 | Bulgaria |
| Novartis Investigative Site | Sofia | 1606 | Bulgaria |
| Novartis Investigative Site | Sofia | 1709 | Bulgaria |
| Novartis Investigative Site | Brno | Czech Republic | 60200 | Czechia |
| Novartis Investigative Site | Chomutov | Czech Republic | 43001 | Czechia |
| Novartis Investigative Site | Svitavy | Czech Republic | 568 25 | Czechia |
| Novartis Investigative Site | Most | CZE | 434 01 | Czechia |
| Novartis Investigative Site | Kolín | 280 20 | Czechia |
| Novartis Investigative Site | Prague | 106 00 | Czechia |
| Novartis Investigative Site | Prague | 150 00 | Czechia |
| Novartis Investigative Site | Elsinore | DK-3000 | Denmark |
| Novartis Investigative Site | Odense C | DK 5000 | Denmark |
| Novartis Investigative Site | Randers | 8930 | Denmark |
| Novartis Investigative Site | Roskilde | 4000 | Denmark |
| Novartis Investigative Site | Svendborg | 5700 | Denmark |
| Novartis Investigative Site | Tallinn | 10138 | Estonia |
| Novartis Investigative Site | Tallinn | 13419 | Estonia |
| Novartis Investigative Site | Tartu | 51014 | Estonia |
| Novartis Investigative Site | Hämeenlinna | 13100 | Finland |
| Novartis Investigative Site | Tampere | 33520 | Finland |
| Novartis Investigative Site | Auxerre | 89000 | France |
| Novartis Investigative Site | Clermont-Ferrand | 63003 | France |
| Novartis Investigative Site | Metz-Tessy | 74370 | France |
| Novartis Investigative Site | Dresden | Saxony | 01099 | Germany |
| Novartis Investigative Site | Bad Homburg | 61348 | Germany |
| Novartis Investigative Site | Berlin | 10787 | Germany |
| Novartis Investigative Site | Berlin | 10789 | Germany |
| Novartis Investigative Site | Berlin | 13055 | Germany |
| Novartis Investigative Site | Berlin | 13353 | Germany |
| Novartis Investigative Site | Buchholz in der Nordheide | 21244 | Germany |
| Novartis Investigative Site | Dietzenbach | 63128 | Germany |
| Novartis Investigative Site | Elsterwerda | 04910 | Germany |
| Novartis Investigative Site | Essen | 45355 | Germany |
| Novartis Investigative Site | Frankfurt | 60594 | Germany |
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| Novartis Investigative Site | Hamburg | 22041 | Germany |
| Novartis Investigative Site | Haßloch | 67454 | Germany |
| Novartis Investigative Site | Leipzig | 04103 | Germany |
| Novartis Investigative Site | Löhne | 32584 | Germany |
| Novartis Investigative Site | Mannheim | 68165 | Germany |
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| Novartis Investigative Site | Nuremberg | 90402 | Germany |
| Novartis Investigative Site | Reinfeld | 23858 | Germany |
| Novartis Investigative Site | Schwäbisch Hall | 74523 | Germany |
| Novartis Investigative Site | Siegen | 57 072 | Germany |
| Novartis Investigative Site | Wallerfing | 94574 | Germany |
| Novartis Investigative Site | Wedel | 22880 | Germany |
| Novartis Investigative Site | Wermsdorf | 04779 | Germany |
| Novartis Investigative Site | Alexandroupoli | Evros | 681 00 | Greece |
| Novartis Investigative Site | Heraklion Crete | Greece | 711 10 | Greece |
| Novartis Investigative Site | Voula | GR | 166 73 | Greece |
| Novartis Investigative Site | Athens | 115 27 | Greece |
| Novartis Investigative Site | Athens | 151 27 | Greece |
| Novartis Investigative Site | Kopavogur | 201 | Iceland |
| Novartis Investigative Site | Reykjavik | IS-101 | Iceland |
| Novartis Investigative Site | Dublin | Ireland |
| Novartis Investigative Site | Jelgava | 3001 | Latvia |
| Novartis Investigative Site | Ogre | 5001 | Latvia |
| Novartis Investigative Site | Riga | 1012 | Latvia |
| Novartis Investigative Site | Riga | LV 1002 | Latvia |
| Novartis Investigative Site | Riga | LV-1001 | Latvia |
| Novartis Investigative Site | Kaunas | LTU | LT 50161 | Lithuania |
| Novartis Investigative Site | Klaipėda | LTU | LT-92288 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
| Novartis Investigative Site | Goes | 4462 RA | Netherlands |
| Novartis Investigative Site | Haarlem | 2035 RC | Netherlands |
| Novartis Investigative Site | Heerlen | 6419 | Netherlands |
| Novartis Investigative Site | Leiderdorp | 2353 GA | Netherlands |
| Novartis Investigative Site | Roermond | 6043 CV | Netherlands |
| Novartis Investigative Site | Veldhoven | 5504 DB | Netherlands |
| Novartis Investigative Site | Feiring | 2093 | Norway |
| Novartis Investigative Site | Warsaw | Masovian Voivodeship | 02-676 | Poland |
| Novartis Investigative Site | Warsaw | 02-097 | Poland |
| Novartis Investigative Site | Warsaw | 02-507 | Poland |
| Novartis Investigative Site | Warsaw | 05077 | Poland |
| Novartis Investigative Site | Lodz | Łódź Voivodeship | 91425 | Poland |
| Novartis Investigative Site | Ferrol | A Coruna | 15405 | Spain |
| Novartis Investigative Site | Elche | Alicante | 03293 | Spain |
| Novartis Investigative Site | Córdoba | Andalusia | 14004 | Spain |
| Novartis Investigative Site | Granada | Andalusia | 18014 | Spain |
| Novartis Investigative Site | Huelva | Andalusia | 21005 | Spain |
| Novartis Investigative Site | Sanlúcar de Barrameda | Andalusia | 11540 | Spain |
| Novartis Investigative Site | Seville | Andalusia | 41009 | Spain |
| Novartis Investigative Site | Villamartín | Cadiz | 11650 | Spain |
| Novartis Investigative Site | Santander | Cantabria | 39008 | Spain |
| Novartis Investigative Site | Aranda de Duero | Castille and León | 09400 | Spain |
| Novartis Investigative Site | Burgos | Castille and León | 09006 | Spain |
| Novartis Investigative Site | León | Castille and León | 24071 | Spain |
| Novartis Investigative Site | Soria | Castille and León | 42005 | Spain |
| Novartis Investigative Site | Sabadell | Catalonia | 08208 | Spain |
| Novartis Investigative Site | Cáceres | Extremadura | 10003 | Spain |
| Novartis Investigative Site | Lugo | Galicia | 27003 | Spain |
| Novartis Investigative Site | Santiago de Compostela | Galicia | 15706 | Spain |
| Novartis Investigative Site | Gijón | Principality of Asturias | 33290 | Spain |
| Novartis Investigative Site | Oviedo | Principality of Asturias | 33011 | Spain |
| Novartis Investigative Site | Alicante | Valencia | 03010 | Spain |
| Novartis Investigative Site | Manises | Valencia | 46940 | Spain |
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| Novartis Investigative Site | Madrid | 28031 | Spain |
| Novartis Investigative Site | Madrid | 28222 | Spain |
| Novartis Investigative Site | Lund | 222 21 | Sweden |
| Novartis Investigative Site | Mölndal | 431 80 | Sweden |
| Novartis Investigative Site | Stockholm | 17176 | Sweden |
| Novartis Investigative Site | Stockton-on-Tees | Cleveland | TS19 8PE | United Kingdom |
| Novartis Investigative Site | Rothwell | GBR | NN14 6JQ | United Kingdom |
| Novartis Investigative Site | Faringdon | Oxfordshire | SN7 7YU | United Kingdom |
| Novartis Investigative Site | Gateshead | Tyne and Wear | NE9 6SX | United Kingdom |
| Novartis Investigative Site | Bournemouth | BH7 7DW | United Kingdom |
| Novartis Investigative Site | Cumbria | CA139HT | United Kingdom |
| Novartis Investigative Site | Poole | BH15 2JB | United Kingdom |
| Novartis Investigative Site | Wellingborough | NN8 4RW | United Kingdom |
| FG001 | Enalapril | Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme. |
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| COMPLETED |
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| NOT COMPLETED |
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| Treatment Phase |
|
All randomized patients are represented in the overall number of Baseline Participants. The Demographic and Baseline Characteristics were done in the Safety Analysis Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LCZ696 (Sacubitril/Valsartan) | LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme. |
| BG001 | Enalapril | Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme. |
| 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 | The Demographic and Baseline Characteristics were done in the Safety Analysis Set. | Mean | Standard Deviation | Years |
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| Sex: Female, Male | The Demographic and Baseline Characteristics were done in the Safety Analysis Set. | Count of Participants | Participants |
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| Race/Ethnicity, Customized | The Demographic and Baseline Characteristics were done in the Safety Analysis Set. | Number | Participants |
|
| 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 | Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at End of Study (Week 12) | The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at 12 weeks. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. | The Full Analysis Set (FAS) and FAS population subset without AE/SAE were considered | Posted | Mean | Standard Deviation | meters | Baseline, Week 12 |
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| Primary | Change From Baseline (Week 0) in Mean Daily Non-sedentary Daytime Activity at End of Study (Week 12) | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity is being calculated over 14 days before randomization (baseline i.e. week -2 to week 0) and the last 14 days of treatment (i.e. week 10 to week 12). | The FAS population with Multiple Imputation (MI), with Last Observation Carried Forward (LOCF) and without MI/LOCF were considered. | Posted | Mean | Standard Deviation | minutes | Baseline, Week 12 |
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| Secondary | Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group. | The Full Analysis Set (FAS) was considered. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | Number and Percentage of Participants With Improved Performance (>= 30 m) in the Six Minute Walk Test (6MWT) - FAS Subset Without AE/SAE | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group. | The Full Analysis Set (FAS) population subset without AE/SAE was considered. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters. | The Full Analysis Set (FAS) was considered for patients with Baseline 6MWT equal to or less than 300 meters. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked Equal to or Less Than 300 Meters at Baseline - FAS Subset Without AE/SAE | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance equal to or less than 300 meters. | The Full Analysis Set (FAS) population subset without AE/SAE was considered for patients with Baseline 6MWT equal to or less than 300 meters. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance from 100 to 450 meters. | The Full Analysis Set (FAS) was considered for patients with Baseline 6MWT between 100 or above and less than 450 meters. | Posted | Count of Participants | Participants | Baseline, Week 12 |
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| Secondary | Number and Percentage of Participants With Improved Performance (>= 30 m) in the 6MWT Which Walked 100-450 Meters at Baseline - FAS Subset Without AE/SAE | The proportion of patients with improved performance (>= 30 meters) in the six-minute walk test (6MWT) was assessed by treatment group in a subset of patients with baseline six-minute walk distance from 100 to 450 meters. | The Full Analysis Set (FAS) population subset without AE/SAE was considered for patients with Baseline 6MWT between 100 or above and less than 450 meters. | Posted | Count of Participants | Participants | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline (Week 0) in the Six Minute Walk Test (6MWT) at Weeks 4 and 8 | The impact of LCZ696 (Sacubitril/Valsartan) and Enalapril on functional exercise capacity was measured by the Six Minute Walk Test at Weeks 4 and 8. The 6MWT measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is able to self-pace and rest as needed as they traverse back and forth along a marked walkway. | The Full Analysis Set (FAS) and FAS population subset without AE/SAE were considered. | Posted | Mean | Standard Deviation | meters | Baseline, Week 4 and Week 8 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants Who Show Increased Levels (>= 10% Increase) of Non Sedentary Daytime Physical Activity at Week 12 Compared to Baseline | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; the average number of minutes per day spent in non-sedentary physical activity will be calculated over 14 days before randomization (baseline) and the last 14 days of treatment (i.e week 10 to week 12) | The Full Analysis Set was considered | Posted | Count of Participants | Participants | Baseline, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants Achieving PGA Score at Weeks 4, 8 and 12 | The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse. | The Full Analysis Set was considered | Posted | Count of Participants | Participants | Week 4, Week 8, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number and Percentage of Participants With Improved Symptoms of Heart Failure as Assessed by Patient Global Assessment (PGA) | The Patient Global Assessment (PGA) is a self-reported tool to assess the patients' subjective rating of their disease activity widely used in HF research. The patients are asked to report functioning or response to an intervention by rating their current condition compared to their pre-intervention condition on a numerical scale: 1) much improved 2) moderately improved 3) a little improved 4) unchanged 5) a little worse 6) moderately worse or 7) much worse. Patients with improved symptoms were categorized as: Improvement, Is unchanged, Gets worse or Missing. | The Full Analysis Set was considered | Posted | Count of Participants | Participants | Week 4, Week 8, Week 12 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Weekly Intervals | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over weekly and compared to before the inclusion. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Non-sedentary Daytime Activity in Two-weekly Intervals | Non-sedentary physical activity is defined as >= 178.50 activity counts per minute; Mean daily non-sedentary daytime physical activity were being calculated over two-weekly intervals and compared to before the inclusion. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Weeks 0 to 2, Weeks 2 to 4, Weeks 4 to 6, Weeks 6 to 8, Weeks 8 to 10, Weeks 10 to 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Light Non-sedentary Daytime Physical Activity | The average number of minutes per day spent in light non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and light physical activity is defined as 178.5 - 565.5 counts per minute. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Moderate-to-Vigorous Non-sedentary Daytime Physical Activity | The average number of minutes per day spent in moderate to vigorous non-sedentary physical activity was being calculated over 7 day epochs. Non-sedentary physical activity is defined as >= 178.5 activity counts per minute and moderate-to-vigorous activity is defined as > 565.5 counts per minute. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Weekly Time Spent in Non-sedentary Daytime Physical Activity | Non-sedentary physical activity is defined as >= 178.5 activity counts per minute; The total time spent in non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Weekly Time Spent in Light Non-sedentary Daytime Physical Activity | Light non-sedentary daytime physical activity is defined as between 178.5 - 565.5 counts per minute; The time spent in light non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Total Weekly Time Spent in Moderate-to-Vigorous Non-sedentary Daytime Physical Activity | Moderate-to-vigorous non-sedentary physical activity is defined as > 565.5 counts per minute. The total time spent in moderate-to-vigorous non-sedentary physical activity was being calculated for each patient in weekly intervals and the temporal course for each patient was assessed. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11 and Week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Peak Six Minutes of Daytime Physical Activity | The peak 6 min walk (M6min) is a parameter derived by validated algorithms of the software that are used to preprocess actigraphy data. The parameter reflected the peak 6 minutes of day time physical activity. The mean daily 6-minute walking test was being calculated over 14 day intervals. | The Full Analysis Set was considered | Posted | Mean | Standard Deviation | minutes | Baseline, Week 2, Week 4, Week 6, Week 8 and Week 12 |
|
|
Adverse Events were collected for the maximum duration of participants' treatment exposure plus any follow up period, approximately 4 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LCZ696 (Sacubitril/Valsartan) | LCZ696 (Sacubitril/Valsartan) or its matching placebo twice a day for 12 weeks. Patients began study treatment (Sacubitril/Valsartan) at a specific dose level according to their pre-study ACEI/ARB dose (1 (24 mg/26 mg LCZ), 2 (49 mg/51 mg LCZ) or 2a (49 mg/51 mg LCZ)) or matching placebo and were up-titrated according to an up-titration scheme. | 1 | 309 | 19 | 309 | 168 | 309 |
| EG001 | Enalapril | Enalapril or its matching placebo twice a day for 12 weeks. Patients began study treatment (Enalapril) at a specific dose level according to their pre-study ACEI/ARB dose (1 (2.5 mg), 2a (5 mg)) or matching placebo and were up-titrated according to an up-titration scheme. | 4 | 310 | 28 | 310 | 143 | 310 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ventricular arrhythmia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Death | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Coronary bypass thrombosis | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Metastatic bronchial carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Stroke in evolution | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Urogenital haemorrhage | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Prostatitis | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin necrosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal lithiasis prophylaxis | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure chronic | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiovascular insufficiency | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ventricular fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Otorrhoea | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Blepharitis | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Retinal vein occlusion | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Aerophagia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chronic gastritis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rectal ulcer | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mucosal dryness | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Campylobacter gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Chlamydial infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Oesophageal candidiasis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Tracheobronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Drug dispensing error | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Underdose | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood 25-hydroxycholecalciferol decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood potassium decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood pressure ambulatory decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Glomerular filtration rate decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Glomerular filtration rate increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Heart rate decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Heart rate increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Laboratory test abnormal | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Red blood cell sedimentation rate increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| White blood cell count increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bladder neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Monoclonal gammopathy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness postural | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Psychotic disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bladder neck obstruction | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal colic | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal disorder | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea paroxysmal nocturnal | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lung disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Obstructive airways disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hair texture abnormal | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Madarosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Inguinal hernia repair | Surgical and medical procedures | MedDRA (21.0) | Systematic Assessment |
| |
| Blood pressure fluctuation | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Intermittent claudication | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral coldness | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
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 | Dec 12, 2018 | Apr 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
| C000717211 | sacubitril |
| D000068756 | Valsartan |
| D004656 | Enalapril |
| ID | Term |
|---|---|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D014633 | Valine |
| D000597 | Amino Acids, Branched-Chain |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000601 | Amino Acids, Essential |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
Not provided
Not provided
|
|
| White |
|
|
| Missing |
|
|
| Week 12 (FAS) |
|
|
| Change from BL at Week 12 (FAS) |
|
|
| Baseline (FAS without AE/SAE) |
|
|
| Week 12 (FAS without AE/SAE) |
|
|
| Change from BL at Week 12 (FAS without AE/SAE) |
|
|
Change from BL at Week 12 (FAS without AE/SAE) |
| ANCOVA |
| 0.0503 |
The comparison of treatment groups were out using an analysis of covariance (ANCOVA) model adjusting for treatment and baseline NYHA class (NYHA II vs. III/IV) and the 6MWT baseline value as covariates. |
| Differences of least square means |
| 8.98 |
| Standard Error of the Mean |
| 4.58 |
| 2-Sided |
| 97.5 |
| -1.31 |
| 19.27 |
| Other |
| Units | Counts |
|---|---|
| Participants |
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| Participants |
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| Participants |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Counts |
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| Participants |
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| Counts |
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| Participants |
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| Units | Counts |
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| Units |
|---|
| Counts |
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| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|
| Counts |
|---|
| Participants |
|
|
|
| Has a little improved |
|
| Is unchanged |
|
| Is a little worse |
|
| Is (moderately) worse |
|
| Is much worse |
|
| Missing |
|
| Has a little improved |
|
| Is unchanged |
|
| Is a little worse |
|
| Is (moderately) worse |
|
| Is much worse |
|
| Missing |
|
| Gets worse |
|
| Missing |
|
| Gets worse |
|
| Missing |
|