HypertensionNCT03255551
Blood Pressure Lowering Effects of Amosartan Regarding Proviso iN Patients With High Blood Pressure
An observational study of Hypertension, run by Seoul National University Bundang Hospital.
Trial summary
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Amosartan
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 31 Dec 2015
- 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: Estimated total number of patients: 3,150 Estimated number of centers: 37
Who may be able to join
- Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy
- In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure
- Patients who were changed to amosartan while using other hypertensive agents
Who cannot join
- Patients with hypersensitivity to dihydropyridine derivatives of amosartan
- Women who are pregnant or who may be pregnant and breastfeeding
- Patients with severe hepatic dysfunction
- Patients with severe aortic stenosis
- Patients at risk of shock
- Patients participating in other clinical studies
About this study
Official title: Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients With Hypertension: Prospective, Multicenter, Observational Study
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
Read the detailed description
After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated
- Conditions
- Hypertension
- Being tested
- Amosartan
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmosartanDrug
amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2017
- Study start1 Jan 2014
- Primary completion30 Jun 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Ju Choi, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03255551
- Sponsor's protocol ID
- LEARN BP
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 21 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.
PubMed 22035131Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003 Jun 28;326(7404):1427. doi: 10.1136/bmj.326.7404.1427.
PubMed 12829555Choi SM, Seo MJ, Kang KK, Kim JH, Ahn BO, Yoo M. Beneficial effects of the combination of amlodipine and losartan for lowering blood pressure in spontaneously hypertensive rats. Arch Pharm Res. 2009 Mar;32(3):353-8. doi: 10.1007/s12272-009-1307-x. Epub 2009 Apr 23.
PubMed 19387578
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients With Hypertension: Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT03255551
- Acronym / sponsor ID
- LEARN BP
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 21 Aug 2017 (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.
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
Detailed description
After taking Amozatan (AMS, amlodipine / rozanthin combination) in patients with essential hypertension, the percentage of patients who reached the mean systolic target blood pressure was evaluated
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Estimated total number of patients: 3,150 Estimated number of centers: 37
Key inclusion criteria (3 listed)
- Patients with essential hypertension whose blood pressure is not adequately controlled by amlodipine or rosartan monotherapy
- In patients with stage 2 hypertension (SBP 160-179 mmHg), patients requiring a combination therapy to reach the target blood pressure
- Patients who were changed to amosartan while using other hypertensive agents
Key exclusion criteria (6 listed)
- Patients with hypersensitivity to dihydropyridine derivatives of amosartan
- Women who are pregnant or who may be pregnant and breastfeeding
- Patients with severe hepatic dysfunction
- Patients with severe aortic stenosis
- Patients at risk of shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amosartanamosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent | Drug | – |
Primary outcome
Patients with essential hypertension evaluated the mean blood pressure after taking amosartan.
Time frame: 6 month
Blood Pressure Lowering Effects of Amosartan Regarding Proviso in Patients with Hypertension
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 21 Aug 2017.
- Background: PubMed 22035131Kim SH, Ryu KH, Lee NH, Kang JH, Kim WS, Park SW, Lee HY, Kim JJ, Ahn YK, Suh SY. Efficacy of fixed-dose amlodipine and losartan combination compared with amlodipine monotherapy in stage 2 hypertension: a randomized, double blind, multicenter study. BMC Res Notes. 2011 Oct 28;4:461. doi: 10.1186/1756-0500-4-461.
- Background: PubMed 12829555Law MR, Wald NJ, Morris JK, Jordan RE. Value of low dose combination treatment with blood pressure lowering drugs: analysis of 354 randomised trials. BMJ. 2003 Jun 28;326(7404):1427. doi: 10.1136/bmj.326.7404.1427.
- Background: PubMed 19387578Choi SM, Seo MJ, Kang KK, Kim JH, Ahn BO, Yoo M. Beneficial effects of the combination of amlodipine and losartan for lowering blood pressure in spontaneously hypertensive rats. Arch Pharm Res. 2009 Mar;32(3):353-8. doi: 10.1007/s12272-009-1307-x. Epub 2009 Apr 23.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Seoul National University Bundang Hospital.
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 3 inclusion and 6 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 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Patients with essential hypertension evaluated the mean blood pressure after taking amosartan. (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03255551, which also lists 3 linked publications.
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 21 Aug 2017.