Pathumwan, Bangkok, Thailand
NCT Number: NCT02467855
Epidemiological Study in Thai Participants With Hypertension
The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Treatment and study plan
No intervention
OtherNo intervention was administered in this study.
Other names: No intervention was administered in this study.
Primary outcomes
-
Percentage of Participants with Controlled Treated Hypertension
Time frame: Up to 16 weeks
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
Treatment regimen for hypertension will be either monotherapy or combination therapy.
-
Types of Antihypertensive Medications and Medication Classes
Time frame: Up to 16 weeks
Sponsors and collaborators
Lead sponsor
Takeda
Industry
Registry information
Official study title
A Multi-Centre, Non-Interventional, Hospital-Based, Cross-Sectional as Well as Longitudinal Epidemiological Study in Thai Subjects With Hypertension
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jun 10, 2015
- Registry last updated
- Nov 13, 2015
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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