HypertensionNCT06683768
A Real-world Study of the Safety of Hypertension Medication Therapy in Japanese Patients With Naïve Hypertension
An observational study of Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- Type of treatment
- Pill or oral medicine
- How many people
- 40,563 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2023to 8 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a retrospective, noninterventional cohort study.
Who may be able to join
- 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.
Who cannot join
- 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.
- Initial prescription of two or more antihypertensive medicines either with or without SPCs at 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.
- 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.
- Pregnant women at any timepoint.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan
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.
- Conditions
- Hypertension
- Keywords
- Essential hypertension, High blood pressure
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monotherapy Cohort | Adult patients with untreated hypertension who initiated antihypertensive monotherapy (excluding angiotensin receptor neprilysin inhibitor [ARNI]). | |
| Single-pill Combination (SPC) Cohort | Adult patients with untreated hypertension who initiated single-pill combination antihypertensive therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
Measured: Week 8 and Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
Measured: Week 8 and Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 8 and Week 24
Secondary outcomes (33)
Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category
BP Categories included Grade I, II, III, and (isolated) systolic hypertension.
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category
BP Categories included Grade I, II, III, and (isolated) systolic hypertension.
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category
BP Categories included Grade I, II, III, and (isolated) systolic hypertension. Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
Age group categories:
- Less than 65 years old
- 65 to 74 years old
- 75 years or older
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
Age group categories:
- Less than 65 years old
- 65 to 74 years old
- 75 years or older
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
Age group categories:
- Less than 65 years old
- 65 to 74 years old
- 75 years or older
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category
BMI categories:
- BMI <18.5
- 18.5 ≤ BMI <25
- 25 ≤ BMI
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category
BMI categories:
- BMI <18.5
- 18.5 ≤ BMI <25
- 25 ≤ BMI
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category
BMI categories:
- BMI <18.5
- 18.5 ≤ BMI <25
- 25 ≤ BMI
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category
eGFR categories:
- eGFR <30
- 30 ≤ eGFR <60
- 60 ≤ eGFR
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category
eGFR categories:
- eGFR <30
- 30 ≤ eGFR <60
- 60 ≤ eGFR
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category
eGFR categories:
- eGFR <30
- 30 ≤ eGFR <60
- 60 ≤ eGFR
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
Potassium (K) levels:
- K <3.5
- 3.5 ≤ K <5.5
- 5.5 ≤ K
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
Potassium (K) levels:
- K <3.5
- 3.5 ≤ K <5.5
- 5.5 ≤ K
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
Potassium (K) levels:
- K <3.5
- 3.5 ≤ K <5.5
- 5.5 ≤ K
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
Creatinine (Cr) Levels:
- Cr <1.5
- 1.5 ≤ Cr
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
Creatinine (Cr) Levels:
- Cr <1.5
- 1.5 ≤ Cr
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
Creatinine (Cr) Levels:
- Cr <1.5
- 1.5 ≤ Cr
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
Proteinuria:
- Urine protein <30: Negative
- 30 ≤ Protein urine: Positive
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
Proteinuria:
- Urine protein <30: Negative
- 30 ≤ Protein urine: Positive
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
Proteinuria:
- Urine protein <30: Negative
- 30 ≤ Protein urine: Positive
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication
Antihypertensive medication classes included calcium channel blockers (CCBs), angiotensin-converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), and diuretics.
Measured: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication
Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics.
Measured: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication
Antihypertensive medication classes included CCBs, ACE inhibitors, ARBs, and diuretics. Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
Measured: Week 24
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category
BP categories included Grade I, II, and III hypertension.
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category
Age group categories:
- Less than 65 years old
- 65 to 74 years old
- 75 years or older
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category
BMI categories:
- BMI <18.5
- 18.5 ≤ BMI <25
- 25 ≤ BMI
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category
eGFR categories:
- eGFR <30
- 30 ≤ eGFR <60
- 60 ≤ eGFR
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level
Potassium (K) levels:
- K <3.5
- 3.5 ≤ K <5.5
- 5.5 ≤ K
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level
Creatinine (Cr) Levels:
- Cr <1.5
- 1.5 ≤ Cr
Measured: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria
Proteinuria:
- Urine protein <30: Negative
- 30 ≤ Protein urine: Positive
Measured: Weeks 4, 8, and 12
Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup
The BP goal was 130/80 millimeters of mercury (mm Hg).
Subgroups:
- BP Grade
- Age
- BMI
- Estimated glomerular filtration rate (eGFR)
- Potassium Level
- Creatinine Level
- Proteinuria (positive or negative)
Measured: Up to 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start28 Feb 2023
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40,563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683768
- Sponsor's protocol ID
- CLCZ696AJP03
- Status last verified
- Nov 2024
- First submitted
- 8 Nov 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Hypertension Medication Therapy in Patient With Naive Hypertension: a Real-world Study in Japan
- ClinicalTrials.gov ID
- NCT06683768
- Acronym / sponsor ID
- CLCZ696AJP03
- Conditions
- Hypertension
- Keywords
- Essential hypertension, High blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40,563 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monotherapy Cohort | – | –Adult patients with untreated hypertension who initiated antihypertensive monotherapy (excluding angiotensin receptor neprilysin inhibitor [ARNI]). |
| Single-pill Combination (SPC) Cohort | – | –Adult patients with untreated hypertension who initiated single-pill combination antihypertensive therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
- Initial prescription of two or more antihypertensive medicines either with or without SPCs at 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.
- 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.
- Pregnant women at any timepoint.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
Time frame: Week 8 and Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
Time frame: Week 8 and Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE
Time frame: Week 8 and Week 24
Incidence rate was calculated by dividing the number of patients who had an event by the total number of patients.
33 secondary outcomes
Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Blood Pressure (BP) Category
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BP Category
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Age Group Category
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Body Mass Index (BMI) Category
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per BMI Category
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Estimated Glomerular Filtration Rate (eGFR) Category
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per eGFR Category
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Potassium Level
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Creatinine Level
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE by Proteinuria
Time frame: Week 24
Number of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication
Time frame: Week 24
Number of Patients With AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication
Time frame: Week 24
Incidence Rate of AEs From Initiation of Antihypertensive Treatment to Week 24 Categorized by Type of AE per Class of Antihypertensive Medication
Time frame: Week 24
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BP Category
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Age Group Category
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by BMI Category
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by eGFR Category
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Potassium Level
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Creatinine Level
Time frame: Weeks 4, 8, and 12
Change in BP From Initiation of Antihypertensive Treatment to Weeks 4, 8, and 12 by Proteinuria
Time frame: Weeks 4, 8, and 12
Number of Patients who Achieved the BP Goal at Last Visit Categorized by Subgroup
Time frame: Up to 13 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (AEs) From Initiation of Antihypertensive Treatment to Weeks 8 and 24 Categorized by Type of AE (time frame: Week 8 and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.