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Completed

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pathumwan, Bangkok, Thailand

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

Other

No intervention was administered in this study.

Other names: No intervention was administered in this study.

Primary outcomes

  1. Percentage of Participants with Controlled Treated Hypertension

    Time frame: Up to 16 weeks

Secondary outcomes

  1. Percentage of Participants for Whom Dose of Current Medications was Increased

    Time frame: Up to 16 weeks

  2. Percentage of Participants for Whom Antihypertensive Medications were Switched

    Time frame: Up to 16 weeks

  3. Percentage of Participants for Whom Second Antihypertensive Drug was Added

    Time frame: Up to 16 weeks

  4. Percentage of Participants for Whom One or More of the Compound of Index Treatment was Removed

    Time frame: Up to 16 weeks

  5. Percentage of Participants in Whom There was No Change in Treatment Regimen

    Time frame: Up to 16 weeks

  6. Reason for Choosing the Treatment Regimens in Hypertension Treatment

    Time frame: Up to 16 weeks

  7. Treatment Regimen for Hypertension

    Time frame: Up to 16 weeks

    Treatment regimen for hypertension will be either monotherapy or combination therapy.

  8. 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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