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This is a single arm, multicenter, observational study to evaluate the safety and efficacy of Entresto Tablets during the first 52 weeks of treatment in Japanese patients with hypertension.
This study is a special drug use surveillance to collect information on the safety specifications under the actual clinical practice of Entresto Tablets in patients with hypertension in Japan to confirm the occurrence and timing of onset of events related to the safety specifications and investigate their risk factors.
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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 |
|---|---|---|
| Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure | To investigate the safety of 52 weeks of treatment with Entresto in patients with hypertension in a real-world setting. In particular, the occurrence status of hypotension, hyperkalemia, and renal impairment/renal failure | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with hypotension, hyperkalemia, and renal impairment/failure by risk factor | To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure | Up to 52 weeks |
| Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure |
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Inclusion Criteria:
Exclusion Criteria:
Patients who have received a formulation containing the same ingredient as Entresto (including investigational product or post-marketing clinical study drug)
The following patients for whom administration of Entresto is contraindicated in the package insert:
Patients with a history or complication of cardiac failure
Patients who have been hospitalized at the start of treatment with Entresto
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Japanese patients with hypertension using Entresto
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anjo | Aichi-ken | 444-1154 | Japan | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Link to study results | View source |
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|
To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure |
| Up to 52 weeks |
| Change from baseline in sitting systolic blood pressure (sSBP) and sitting diastolic blood pressure (sDBP) over time | To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting | Up to 52 weeks |
| Percentage of patients who achieved blood pressure control at each evaluation time point | To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting | Up to 52 weeks |
| Percentage of patients who achieved improvement in sSBP and sDBP at each evaluation time point | To evaluate the efficacy of 52 weeks of treatment with Entresto in a real-world setting | Up to 52 weeks |
| Ichinomiya |
| Aichi-ken |
| 494-0001 |
| Japan |
| Novartis Investigative Site | Kasugai | Aichi-ken | 487-0024 | Japan |
| Novartis Investigative Site | Nagoya | Aichi-ken | 460-0004 | Japan |
| Novartis Investigative Site | Okazaki | Aichi-ken | 444-0856 | Japan |
| Novartis Investigative Site | Ōbu | Aichi-ken | 474-0044 | Japan |
| Novartis Investigative Site | Toyohashi | Aichi-ken | 440-0836 | Japan |
| Novartis Investigative Site | Yatomi | Aichi-ken | 498-0048 | Japan |
| Novartis Investigative Site | Inzai | Chiba | 270-1334 | Japan |
| Novartis Investigative Site | Matsudo | Chiba | 270-0034 | Japan |
| Novartis Investigative Site | Sakura | Chiba | 285-8765 | Japan |
| Novartis Investigative Site | Yotsukaidō | Chiba | 284-0027 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-0051 | Japan |
| Novartis Investigative Site | Matsuyama | Ehime | 790-0932 | Japan |
| Novartis Investigative Site | Saijō | Ehime | 799-1371 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 815-0033 | Japan |
| Novartis Investigative Site | Fukuoka | Fukuoka | 815-0041 | Japan |
| Novartis Investigative Site | Kasuga | Fukuoka | 816-0807 | Japan |
| Novartis Investigative Site | Kasuga | Fukuoka | 816-0833 | Japan |
| Novartis Investigative Site | Kasuya Gun | Fukuoka | 811-2202 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 804-0081 | Japan |
| Novartis Investigative Site | Kitakyushu | Fukuoka | 805-0019 | Japan |
| Novartis Investigative Site | Kurume | Fukuoka | 830-0011 | Japan |
| Novartis Investigative Site | Nakagawa | Fukuoka | 811-1244 | Japan |
| Novartis Investigative Site | Omuta | Fukuoka | 837-0916 | Japan |
| Novartis Investigative Site | Yame | Fukuoka | 834-0004 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 731-0102 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 731-0154 | Japan |
| Novartis Investigative Site | Hiroshima | Hiroshima | 731-0221 | Japan |
| Novartis Investigative Site | Takehara | Hiroshima | 725-0026 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 001-0017 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 060-0031 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 064-0802 | Japan |
| Novartis Investigative Site | Sapporo | Hokkaido | 064-0809 | Japan |
| Novartis Investigative Site | Akashi | Hyōgo | 673-0023 | Japan |
| Novartis Investigative Site | Amagasaki | Hyōgo | 660-0861 | Japan |
| Novartis Investigative Site | Kasai | Hyōgo | 679-0103 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 650-0047 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 651-1302 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 651-1505 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 651-2135 | Japan |
| Novartis Investigative Site | Kobe | Hyōgo | 654-0121 | Japan |
| Novartis Investigative Site | Nishinomiya | Hyōgo | 663-8107 | Japan |
| Novartis Investigative Site | Bandō | Ibaraki | 306-0631 | Japan |
| Novartis Investigative Site | Chikusei | Ibaraki | 309-1195 | Japan |
| Novartis Investigative Site | Koga | Ibaraki | 306-0232 | Japan |
| Novartis Investigative Site | Moriya | Ibaraki | 302-0118 | Japan |
| Novartis Investigative Site | Ryūgasaki | Ibaraki | 301-0005 | Japan |
| Novartis Investigative Site | Kanazawa | Ishikawa-ken | 920-0007 | Japan |
| Novartis Investigative Site | Kagoshima | Kagoshima-ken | 892-0862 | Japan |
| Novartis Investigative Site | Aiko-gun | Kanagawa | 243-0301 | Japan |
| Novartis Investigative Site | Fujisawa | Kanagawa | 252-0804 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 225-0013 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 2260025 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 2270046 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 232-0052 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 235-0045 | Japan |
| Novartis Investigative Site | Yokohama | Kanagawa | 241-0821 | Japan |
| Novartis Investigative Site | Yokosuka | Kanagawa | 238-0007 | Japan |
| Novartis Investigative Site | Kumamoto | Kumamoto | 862-0924 | Japan |
| Novartis Investigative Site | Yamaga | Kumamoto | 861-0382 | Japan |
| Novartis Investigative Site | Iki | Nagasaki | 811-5135 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8055 | Japan |
| Novartis Investigative Site | Nagasaki | Nagasaki | 852-8511 | Japan |
| Novartis Investigative Site | Nakatsu | Oita Prefecture | 871-0152 | Japan |
| Novartis Investigative Site | Ōita | Oita Prefecture | 870-0837 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 710-1101 | Japan |
| Novartis Investigative Site | Kurashiki | Okayama-ken | 713-8121 | Japan |
| Novartis Investigative Site | Hirakata | Osaka | 573-0058 | Japan |
| Novartis Investigative Site | Ikeda | Osaka | 563-0047 | Japan |
| Novartis Investigative Site | Minoo | Osaka | 562-0046 | Japan |
| Novartis Investigative Site | Moriguchi | Osaka | 570-0012 | Japan |
| Novartis Investigative Site | Moriguchi | Osaka | 570-8507 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 533-0013 | Japan |
| Novartis Investigative Site | Osaka | Osaka | 534-0024 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0862 | Japan |
| Novartis Investigative Site | Suita | Osaka | 565-0874 | Japan |
| Novartis Investigative Site | Takatsuki | Osaka | 569-1121 | Japan |
| Novartis Investigative Site | Toyonaka | Osaka | 561-0881 | Japan |
| Novartis Investigative Site | Kashima | Saga-ken | 849-1311 | Japan |
| Novartis Investigative Site | Kishima-gun | Saga-ken | 849-1203 | Japan |
| Novartis Investigative Site | Tosu | Saga-ken | 841-0061 | Japan |
| Novartis Investigative Site | Ureshino | Saga-ken | 843-0302 | Japan |
| Novartis Investigative Site | Asaka | Saitama | 3510021 | Japan |
| Novartis Investigative Site | Fujimino | Saitama | 356-0011 | Japan |
| Novartis Investigative Site | Gyōda | Saitama | 361-0056 | Japan |
| Novartis Investigative Site | Kawaguchi | Saitama | 333-0847 | Japan |
| Novartis Investigative Site | Niiza | Saitama | 352-0023 | Japan |
| Novartis Investigative Site | Saitama | Saitama | 339-0033 | Japan |
| Novartis Investigative Site | Satte | Saitama | 340-0115 | Japan |
| Novartis Investigative Site | Sayama | Saitama | 350-1305 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-1106 | Japan |
| Novartis Investigative Site | Tokorozawa | Saitama | 359-1141 | Japan |
| Novartis Investigative Site | Akishima | Tokyo | 196-0015 | Japan |
| Novartis Investigative Site | Edogawa-ku | Tokyo | 134-0081 | Japan |
| Novartis Investigative Site | Hachiōji | Tokyo | 192-0918 | Japan |
| Novartis Investigative Site | Katsushika-ku | Tokyo | 125-0042 | Japan |
| Novartis Investigative Site | Kokubunji | Tokyo | 185-0011 | Japan |
| Novartis Investigative Site | Koto-ku | Tokyo | 135-0003 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 194-0021 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 1940013 | Japan |
| Novartis Investigative Site | Machida | Tokyo | 195-0074 | Japan |
| Novartis Investigative Site | Mitaka | Tokyo | 181-0013 | Japan |
| Novartis Investigative Site | Ōta-ku | Tokyo | 146-8531 | Japan |
| Novartis Investigative Site | Setagaya-ku | Tokyo | 157-0066 | Japan |
| Novartis Investigative Site | Shibuya City | Tokyo | 151-0053 | Japan |
| Novartis Investigative Site | Toshima-ku | Tokyo | 171-0014 | Japan |
| Novartis Investigative Site | Takaoka | Toyama | 939-1104 | Japan |
| Novartis Investigative Site | Shimonoseki | Yamaguchi | 759-6301 | Japan |
| Novartis Investigative Site | Yamaguchi | Yamaguchi | 754-0002 | Japan |
| Novartis Investigative Site | Fukuoka | 810-0044 | Japan |
| Novartis Investigative Site | Fukuoka | 810-0801 | Japan |
| Novartis Investigative Site | Fukuoka | 812-0025 | Japan |
| Novartis Investigative Site | Fukuoka | 812-0039 | Japan |
| Novartis Investigative Site | Fukuoka | 814-0163 | Japan |
| Novartis Investigative Site | Saitama | 3300074 | Japan |
| Novartis Investigative Site | Saitama | 338-0837 | Japan |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C549068 | sacubitril and valsartan sodium hydrate drug combination |
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