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.
Study Type
OBSERVATIONAL
Enrollment
1,125
There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.
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
Time frame: Up to 52 weeks
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
Time frame: Up to 52 weeks
Odds ratio (OR) for each risk factor of hypotension, hyperkalemia, and renal impairment/failure
To identify risk factors associated with the development of hypotension, hyperkalemia, and renal impairment/failure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 52 weeks
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Novartis Investigative Site
Anjo, Aichi-ken, Japan
Novartis Investigative Site
Ichinomiya, Aichi-ken, Japan
Novartis Investigative Site
Kasugai, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Okazaki, Aichi-ken, Japan
Novartis Investigative Site
Ōbu, Aichi-ken, Japan
Novartis Investigative Site
Toyohashi, Aichi-ken, Japan
Novartis Investigative Site
Yatomi, Aichi-ken, Japan
Novartis Investigative Site
Inzai, Chiba, Japan
Novartis Investigative Site
Matsudo, Chiba, Japan
...and 107 more locations