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This is a single arm, multicenter, observational study in Japanese chronic heart failure patients.
This study is a special drug use surveillance to evaluate the safety and efficacy of Entresto Tablets (hereafter called Entresto) clinically administered in Japanese patients for the newly approved indication of "chronic heart failure" and to be conducted as one of the RMP-specified additional pharmacovigilance activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entresto | Patients administered Entresto by prescription |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entresto | Drug | There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of Entresto in chronic heart failure patients | EAIR of hypotension, hyperkalemia, renal impairment and dehydration will be collected. EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the impact of risk factors | Subgroup analysis of EAIR (patients/100 patient-years) of hypotension, hyperkalemia, renal impairment and dehydration by risk factor will be presented EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Japanese patients using Entresto for the newly approved indication of "chronic heart failure"
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ichinomiya | Aichi-ken | 493-0004 | Japan | ||
| Novartis Investigative Site |
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| To investigate the occurrence of AEs, SAEs, ADRs and serious ADRs | A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal. An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Entresto or whose causality is not recorded | Up to 52 weeks |
| EAIR for each of the clinical events | EAIR: n/T, n: total number of events included in the analysis, T(100 patient years): total up-to-event/censoring duration-time summarized over patients | Up to 52 weeks |
| Kaplan-Meier curve for each of the clinical events | Kaplan-Meier estimate of cumulative failure rate(%) will be collected | Up to 52 weeks |
| Total frequency of hospitalization due to heart failure | Total frequency of hospitalization due to heart failure will be collected | Up to 52 weeks |
| To investigate data on the administration of Entresto in clinical use | Data on Entresto administration will be collected | Up to 52 weeks |
| Ichinomiya |
| Aichi-ken |
| 494-0001 |
| Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 460-0004 | Japan |
| Novartis Investigative Site | Nishio | Aichi-ken | 444-0403 | Japan |
| Novartis Investigative Site | Ōbu | Aichi-ken | 474-0044 | Japan |
| Novartis Investigative Site | Yatomi | Aichi-ken | 498-0048 | Japan |
| Novartis Investigative Site | Funabashi | Chiba | 273-0031 | Japan |
| Novartis Investigative Site | Kashiwa | Chiba | 277-0054 | Japan |
| Novartis Investigative Site | Sakura | Chiba | 285-8765 | Japan |
| Novartis Investigative Site | Yachiyo | Chiba | 276-8524 | Japan |
| Novartis Investigative Site | Imabari | Ehime | 794-0052 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-0932 | Japan |
| Novartis Investigative Site | Chikushino-shi | Fukuka | 818-8516 | Japan |
| Novartis Investigative Site | Kasuya-gun | Fukuoka | 811-2311 | Japan |
| Novartis Investigative Site | Ukiha | Fukuoka | 839-1306 | Japan |
| Novartis Investigative Site | Iwaki | Fukushima | 979-0201 | Japan |
| Novartis Investigative Site | Maebashi | Gunma | 371-0004 | Japan |
| Novartis Investigative Site | Takasaki | Gunma | 370-0046 | Japan |
| Novartis Investigative Site | Fuchū | Hiroshima | 726-0013 | Japan |
| Novartis Investigative Site | Mihara | Hiroshima | Japan |
| Novartis Investigative Site | Takehara | Hiroshima | 725-0012 | Japan |
| Novartis Investigative Site | Takehara | Hiroshima | 725-0026 | Japan |
| Novartis Investigative Site | Abashiri | Hokkaido | 092-0235 | Japan |
| Novartis Investigative Site | Fukagawa | Hokkaido | 074-0006 | Japan |
| Novartis Investigative Site | Hakodate | Hokkaido | 041-8522 | Japan |
| Novartis Investigative Site | Ishikari | Hokkaido | 061-3217 | Japan |
| Novartis Investigative Site | Iwamizawa | Hokkaido | 068-0004 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 004-0052 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 007-0849 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 065-0012 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 065-0027 | Japan |
| Novartis Investigative Site | Akashi | Hyōgo | 673-0023 | Japan |
| Novartis Investigative Site | Awaji | Hyōgo | 656-2131 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 670-0811 | Japan |
| Novartis Investigative Site | Himeji | Hyōgo | 672-8035 | Japan |
| Novartis Investigative Site | Kakogawa | Hyōgo | 675-0017 | Japan |
| Novartis Investigative Site | Kakogawa | Hyōgo | 675-0101 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0047 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 654-0121 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 657-0051 | Japan |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 663-8107 | Japan |
| Novartis Investigative Site | Takarazuka | Hyōgo | 665-0861 | Japan |
| Novartis Investigative Site | Takarazuka | Hyōgo | 665-0873 | Japan |
| Novartis Investigative Site | Mito | Ibaraki | 310-0004 | Japan |
| Novartis Investigative Site | Mito | Ibaraki | 310-0841 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920-0007 | Japan |
| Novartis Investigative Site | Morioka | Iwate | 020-0871 | Japan |
| Novartis Investigative Site | Takamatsu | Kagawa-ken | 761-8063 | Japan |
| Novartis Investigative Site | Fujisawa | Kanagawa | 252-0802 | Japan |
| Novartis Investigative Site | Kamakura | Kanagawa | 248-0011 | Japan |
| Novartis Investigative Site | Sagamihara | Kanagawa | 252-0105 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 236 0037 | Japan |
| Novartis Investigative Site | Mukou-City | Kyoto | 617-0002 | Japan |
| Novartis Investigative Site | Iga | Mie-ken | 518-0121 | Japan |
| Novartis Investigative Site | Tamaru | Mie-ken | 516-0101 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-0823 | Japan |
| Novartis Investigative Site | Tsu | Mie-ken | 514-8508 | Japan |
| Novartis Investigative Site | Higashimatsushima | Miyagi | 981-0501 | Japan |
| Novartis Investigative Site | Shiogama | Miyagi | 985-0087 | Japan |
| Novartis Investigative Site | Saito | Miyazaki | 881-0003 | Japan |
| Novartis Investigative Site | Iki | Nagasaki | 811-5135 | Japan |
| Novartis Investigative Site | Sasebo | Nagasaki | 857-0053 | Japan |
| Novartis Investigative Site | Kita-Katsuragi-gun | Nara | 636-0002 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 710-1101 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 713-8121 | Japan |
| Novartis Investigative Site | Urasoe | Okinawa | 901-2132 | Japan |
| Novartis Investigative Site | Sakai | Osaka | 590-0111 | Japan |
| Novartis Investigative Site | Kishima-gun | Saga-ken | 849-0401 | Japan |
| Novartis Investigative Site | Ureshino | Saga-ken | 843-0302 | Japan |
| Novartis Investigative Site | Kawaguchi | Saitama | 332-0001 | Japan |
| Novartis Investigative Site | Kawaguchi | Saitama | 333-0847 | Japan |
| Novartis Investigative Site | Sayama | Saitama | 350-1305 | Japan |
| Novartis Investigative Site | Toda | Saitama | 335-0013 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 351-1151 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-1142 | Japan |
| Novartis Investigative Site | Higashiohmi | Shiga | 527-0134 | Japan |
| Novartis Investigative Site | Gotemba | Shizuoka | 412-0043 | Japan |
| Novartis Investigative Site | Hamamatsu | Shizuoka | 434-0011 | Japan |
| Novartis Investigative Site | Sunto-gun | Shizuoka | 411-0917 | Japan |
| Novartis Investigative Site | Nasushiobara | Tochigi | 329-2763 | Japan |
| Novartis Investigative Site | Utsunomiya | Tochigi | 321-0917 | Japan |
| Novartis Investigative Site | Adachi City | Tokyo | 123-0845 | Japan |
| Novartis Investigative Site | Adachi City | Tokyo | 123-0864 | Japan |
| Novartis Investigative Site | Akiruno | Tokyo | 197-0804 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0046 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0918 | Japan |
| Novartis Investigative Site | Katsushika-ku | Tokyo | 124-0021 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 194-0013 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 194-0043 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 195-0074 | Japan |
| Novartis Investigative Site | Minato | Tokyo | 106-0031 | Japan |
| Novartis Investigative Site | Minato-ku | Tokyo | 108-8329 | Japan |
| Novartis Investigative Site | Nakano City | Tokyo | 165-0022 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 144-0051 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 144-8501 | Japan |
| Novartis Investigative Site | Toshima City | Tokyo | 171-0033 | Japan |
| Novartis Investigative Site | Takaoka | Toyama | 939-1104 | Japan |
| Novartis Investigative Site | Sakata | Yamagata | 998-8501 | Japan |
| Novartis Investigative Site | Shinjō | Yamagata | 996-0035 | Japan |
| Novartis Investigative Site | Shimonoseki | Yamaguchi | 759-6301 | Japan |
| Novartis Investigative Site | Gifu | 500-8384 | Japan |
| Novartis Investigative Site | Hiroshima | 731-0102 | Japan |
| Novartis Investigative Site | Hiroshima | 731-0113 | Japan |
| Novartis Investigative Site | Hiroshima | 731-0154 | Japan |
| Novartis Investigative Site | Kumamoto | 861-4115 | Japan |
| Novartis Investigative Site | Kumamoto | 862-0916 | Japan |
| Novartis Investigative Site | Kumamoto | 862-0924 | Japan |
| Novartis Investigative Site | Kyoto | 612-8555 | Japan |
| Novartis Investigative Site | Nagasaki | 852-8055 | Japan |
| Novartis Investigative Site | Osaka | 531-0071 | Japan |
| Novartis Investigative Site | Osaka | 533-0001 | Japan |
| Novartis Investigative Site | Osaka | 533-0013 | Japan |
| Novartis Investigative Site | Osaka | 537-0024 | Japan |
| Novartis Investigative Site | Ōita | 870-0955 | Japan |
| Novartis Investigative Site | Ōita | 879-7761 | Japan |
| Novartis Investigative Site | Saitama | 338-0837 | Japan |
| Novartis Investigative Site | Shizuoka | 420-0867 | Japan |
| Novartis Investigative Site | Tokushima | 770-8079 | Japan |
| Novartis Investigative Site | Toyama | 939-8081 | Japan |
| Novartis Investigative Site | Wakayama | 641-0006 | Japan |
| Novartis Investigative Site | Yamaguchi | 754-0002 | Japan |
| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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