NCT06683768Completed
A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension
Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan
Source: ClinicalTrials.gov · Last updated 20 Nov 2024
Brief summary (registry, in English)
This was a non-interventional, secondary use of data, retrospective, cohort study. The data 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. (Tokyo, Japan). JAMDAS is a database that aggregates medical information and is constructed mainly from electronic medical record information of medical institutions, 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
- 40563 (actual)
- First submitted
- 8 Nov 2024
- Start date
- 28 Feb 2023
- Primary completion date
- 8 Nov 2023
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- High blood pressure
- NCT number
- NCT06683768
What you commit to
- Study type: Observational
- Participants enrolled: 40563
- From 28 Feb 2023 to the primary completion date, 8 Nov 2023
- 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 design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prescription of hypertensive medication including alpha blocker, beta blocker, alpha-beta blocker, aldosterone antagonist, and renin inhibitor within 24 weeks prior to the index date.
- History of hypotension, hyperkalemia, hypokalemia, or hyponatremia, drug-related or otherwise, or renal failure leading to dialysis, stroke, myocardial infarction, heart failure at the index date or within 24 weeks prior to the index date.
Other illness
- History of secondary hypertension (renal parenchymal hypertension, renovascular hypertension \[unilateral or bilateral renal artery stenosis\] coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension, etc.) at any timepoint.
Other
- Initial prescription of two or more antihypertensive medicines either with or without SPCs at the index date.
- Pregnant women at any timepoint.
Who the study is looking for
- Diagnosed with essential hypertension or hypertensive heart/kidney disease at the index date.
- Sitting systolic blood pressure (sSBP) ≥150 millimeters of mercury (mm Hg) at the index date.
- At least one prescription of angiotensin-converting enzyme inhibitor (ACEi), angiotensin receptor blocker (ARB), angiotensin receptor neprilysin inhibitor (ARNI), calcium channel blocker (CCB), diuretics, or these SPCs for hypertension at the index date.
- At least one visit and blood pressure (BP) measurement within 12 weeks from the index date.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novartis Pharmaceuticals Coordinator of this site? Confirm its status | East Hanover | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.