Epidemiological Study in Thai Participants With Hypertension

Completed

• Conditions: Hypertension
• Interventions: Other: No Intervention

• Registration Number: NCT02467855
• Lead Sponsor: Takeda

Brief Summary

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 Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-04-23
• Study First Submitted QC: 2015-06-05
• Study First Posted: 2015-06-10
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-12
• Last Update Posted: 2015-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2071

Inclusion Criteria

1. Ability to provide written informed consent
2. Age above 18 years.
3. 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.

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Exclusion Criteria

1. Female participants who are breastfeeding or pregnant or who are intending to become pregnant.
2. Has known or suspected secondary hypertension.
3. 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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cross-Sectional Cohort	No Intervention	Participants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit.
Longitudinal Cohort	No Intervention	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants with Controlled Treated Hypertension	Up to 16 weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in Whom There was No Change in Treatment Regimen	Up to 16 weeks
Percentage of Participants for Whom Dose of Current Medications was Increased	Up to 16 weeks
Reason for Choosing the Treatment Regimens in Hypertension Treatment	Up to 16 weeks
Percentage of Participants for Whom One or More of the Compound of Index Treatment was Removed	Up to 16 weeks
Treatment Regimen for Hypertension	Up to 16 weeks	Treatment regimen for hypertension will be either monotherapy or combination therapy.
Percentage of Participants for Whom Antihypertensive Medications were Switched	Up to 16 weeks
Percentage of Participants for Whom Second Antihypertensive Drug was Added	Up to 16 weeks
Types of Antihypertensive Medications and Medication Classes	Up to 16 weeks