HypertensionNCT02467855
Epidemiological Study in Thai Participants With Hypertension
An observational study of Hypertension, run by Takeda at 1 site in Thailand.
Trial summary
The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 2,071 participants
- Where
- 1 siteThailand
- Study dates
- Oct 2014to Aug 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: Participants with essential hypertension will be enrolled from outpatient hospital departments or hospital clinics in Thailand.
Who may be able to join
- Ability to provide written informed consent
- Age above 18 years.
- Participants with essential hypertension as per European Society of Hypertension/European Society of Cardiology (ESH/ESC) criteria in general, target blood pressure (BP), systolic blood pressure (SBP) <140 and diastolic blood pressure (DBP) <90 mmHg, in diabetes, target BP, SBP <140 and DBP <85 mmHg, in renal disease with overt proteinuria (urine albumin excretion > 300 mg/day or 200 microgram/min), target BP, SBP <130 and DBP <90 mmHg).
- Essential Hypertension will be defined based on the criteria established by the ESH/ESC 2013 criteria:
- Grade 1 Essential hypertension - Systolic blood pressure (SBP) 140 - 159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg with no identifiable cause
- Grade 2 Essential hypertension - SBP 160 - 179 mmHg and/or DBP 100 - 109 mmHg with no identifiable cause
- Grade 3 Essential hypertension-SBP ≥ 180 and/or DBP ≥ 110 mmHg with no identifiable cause.
Who cannot join
- Female participants who are breastfeeding or pregnant or who are intending to become pregnant.
- Has known or suspected secondary hypertension.
- Is currently enrolled in or has not yet completed at least 30 days since ending an investigational product or device study or is receiving other investigational agents.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre, Non-Interventional, Hospital-Based, Cross-Sectional as Well as Longitudinal Epidemiological Study in Thai Subjects With Hypertension
The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.
Read the detailed description
This study has been designed as a non-interventional, observational study to obtain information on hypertension treatment regimens and how well hypertension is controlled in Thai patients in real-life settings. Antihypertensive medications prescribed in this study will be at the discretion of the investigator and the standard of care practice at the particular study site.
The study will enroll approximately 2000 patients. Participants with well-controlled hypertension on their current antihypertensive therapy will participate in the study for only 1 visit. Participants with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. These participants will make 3 visits to the study site.
This multi-centre trial will be conducted in Thailand.
- Conditions
- Hypertension
- Being tested
- No Intervention
- Keywords
- Drug therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
Also called No intervention was administered in this study.
No intervention was administered in this study.
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional Cohort | Participants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit. Receives: Other: No Intervention | |
| Longitudinal Cohort | Participants receiving standard of care for hypertension with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Controlled Treated Hypertension
Measured: Up to 16 weeks
Secondary outcomes (8)
Percentage of Participants for Whom Dose of Current Medications was Increased
Measured: Up to 16 weeks
Percentage of Participants for Whom Antihypertensive Medications were Switched
Measured: Up to 16 weeks
Percentage of Participants for Whom Second Antihypertensive Drug was Added
Measured: Up to 16 weeks
Percentage of Participants for Whom One or More of the Compound of Index Treatment was Removed
Measured: Up to 16 weeks
Percentage of Participants in Whom There was No Change in Treatment Regimen
Measured: Up to 16 weeks
Reason for Choosing the Treatment Regimens in Hypertension Treatment
Measured: Up to 16 weeks
Treatment Regimen for Hypertension
Treatment regimen for hypertension will be either monotherapy or combination therapy.
Measured: Up to 16 weeks
Types of Antihypertensive Medications and Medication Classes
Measured: Up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2015 (estimated)
- Study startOct 2014
- Primary completionAug 2015
- Study completionAug 2015
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 TakedaThe 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
- Prospective
- Enrolment
- 2,071 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director Clinical Science, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467855
- Sponsor's protocol ID
- AZI-P4-003
- Status last verified
- Nov 2015
- First submitted
- 23 Apr 2015
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Non-Interventional, Hospital-Based, Cross-Sectional as Well as Longitudinal Epidemiological Study in Thai Subjects With Hypertension
- ClinicalTrials.gov ID
- NCT02467855
- Acronym / sponsor ID
- AZI-P4-003
- Conditions
- Hypertension
- Keywords
- Drug therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,071 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Jun 2015 (estimated)
- 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.
The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.
Detailed description
This study has been designed as a non-interventional, observational study to obtain information on hypertension treatment regimens and how well hypertension is controlled in Thai patients in real-life settings. Antihypertensive medications prescribed in this study will be at the discretion of the investigator and the standard of care practice at the particular study site.
The study will enroll approximately 2000 patients. Participants with well-controlled hypertension on their current antihypertensive therapy will participate in the study for only 1 visit. Participants with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. These participants will make 3 visits to the study site.
This multi-centre trial will be conducted in Thailand.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Cohort | – | Other: No InterventionParticipants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit. |
| Longitudinal Cohort | – | Other: No InterventionParticipants receiving standard of care for hypertension with history of hypertension who are uncontrolled on the current antihypertensive medications or participants with newly diagnosed hypertension (diagnosed within the past 4 weeks and uncontrolled on antihypertensive therapy) will be observed over the course of 12-16 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with essential hypertension will be enrolled from outpatient hospital departments or hospital clinics in Thailand.
Key inclusion criteria (7 listed)
- Ability to provide written informed consent
- Age above 18 years.
- Participants with essential hypertension as per European Society of Hypertension/European Society of Cardiology (ESH/ESC) criteria in general, target blood pressure (BP), systolic blood pressure (SBP) <140 and diastolic blood pressure (DBP) <90 mmHg, in diabetes, target BP, SBP <140 and DBP <85 mmHg, in renal disease with overt proteinuria (urine albumin excretion > 300 mg/day or 200 microgram/min), target BP, SBP <130 and DBP <90 mmHg).
- Essential Hypertension will be defined based on the criteria established by the ESH/ESC 2013 criteria:
- Grade 1 Essential hypertension - Systolic blood pressure (SBP) 140 - 159 mmHg and/or diastolic blood pressure (DBP) 90-99 mmHg with no identifiable cause
Key exclusion criteria (3 listed)
- Female participants who are breastfeeding or pregnant or who are intending to become pregnant.
- Has known or suspected secondary hypertension.
- Is currently enrolled in or has not yet completed at least 30 days since ending an investigational product or device study or is receiving other investigational agents.
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 |
|---|---|---|
| No InterventionAlso: No intervention was administered in this study.No intervention was administered in this study. | Other | Cross-Sectional Cohort, Longitudinal Cohort |
Primary outcome
Percentage of Participants with Controlled Treated Hypertension
Time frame: Up to 16 weeks
8 secondary outcomes
Percentage of Participants for Whom Dose of Current Medications was Increased
Time frame: Up to 16 weeks
Percentage of Participants for Whom Antihypertensive Medications were Switched
Time frame: Up to 16 weeks
Percentage of Participants for Whom Second Antihypertensive Drug was Added
Time frame: Up to 16 weeks
Percentage of Participants for Whom One or More of the Compound of Index Treatment was Removed
Time frame: Up to 16 weeks
Percentage of Participants in Whom There was No Change in Treatment Regimen
Time frame: Up to 16 weeks
Reason for Choosing the Treatment Regimens in Hypertension Treatment
Time frame: Up to 16 weeks
Treatment Regimen for Hypertension
Time frame: Up to 16 weeks
Types of Antihypertensive Medications and Medication Classes
Time frame: Up to 16 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 13 Nov 2015.
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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.
Medical Director Clinical Science study director
Takeda
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 Takeda at 1 site in Thailand.
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 7 inclusion and 3 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 13 Nov 2015. 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 Thailand. 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?
Percentage of Participants with Controlled Treated Hypertension (time frame: Up to 16 weeks). 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 13 Nov 2015.