NCT06604897Completed
Effectiveness of Entresto (Sacubitril/Valsartan) in Japanese Patients With Hypertension
Effectiveness of Entresto (Sacubitril/Valsartan) to Blood Pressure Control in Japanese Patients With Hypertension: the Database Analysis of Electronic Medical Records
Source: ClinicalTrials.gov · Last updated 14 Aug 2026
Brief summary (registry, in English)
This study was a non-interventional, secondary use of data, retrospective, cohort study, and the data to be extracted in this study was used as secondary use of collected patient information in the database (Japan Medical Data Survey \[JAMDAS\]) owned by M3 Inc. JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of general practices, allowing real-time extraction of information entered in medical records, such as prescription status including drug switching and continuation, laboratory values, clinical evaluation scores, and comorbidities, etc.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1405 (actual)
- First submitted
- 17 Sept 2024
- Start date
- 31 Jan 2023
- Primary completion date
- 31 Oct 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- High blood pressure
- NCT number
- NCT06604897
What you commit to
- Study type: Observational
- Participants enrolled: 1405
- From 31 Jan 2023 to the primary completion date, 31 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Women with a record of pregnancy-related diagnoses, drugs, or medical procedures before or after the index date, or a record of delivery- or abortion-related diagnoses, drugs, or medical procedures after the index date.
- Prescription of concomitant angiotensin-converting enzyme inhibitor (ACEi); Anatomical Therapeutic Chemical (ATC) code: C09A on, after, or in the 2 days before the index date.
- Patients diagnosed with diabetes and under treatment with aliskiren fumarate on the index date.
Other
- Patients diagnosed with angioedema: ICD-10: D84.1 under prescription of ACEi or angiotensin receptor blocker (ARB); ATC code: C09C.
- Patients with severe impaired liver functions with Child-Pugh classification C.
Who the study is looking for
- Diagnosed with essential hypertension (International Classification of Diseases \[ICD\]-10 code: I10) on the index date.
- Patients for whom data for the 6 months prior to the index date can be extracted as baseline data.
- Patients for whom blood pressure (BP) data can be extracted between weeks 8 and 12 after the index date.
- Patients whose BP data can be extracted on the index date.
- Patients whose BP value at baseline was 140/90 millimeters of mercury (mmHg) or higher.
- Patients with the prescription of 100 milligrams (mg) or 200 mg once daily as 100 mg or 200 mg tablets on the index date.
Age in the registry: 20 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.