Epidemiological Study in Thai Participants With Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Other: No Intervention

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 Type: Observational
• Enrollment (Actual): 2071

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Pathumwan, Bangkok, Thailand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with essential hypertension will be enrolled from outpatient hospital departments or hospital clinics in Thailand.

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cross-Sectional Cohort; Participants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit.	Other: No Intervention; No intervention was administered in this study.; Other Names: No intervention was administered in this study.
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.	Other: No Intervention; No intervention was administered in this study.; Other Names: No intervention was administered in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Participants with Controlled Treated Hypertension	Up to 16 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: April 23, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 10, 2015

Study Record Updates

• Last Update Posted (Estimate): November 13, 2015
• Last Update Submitted That Met QC Criteria: November 12, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: AZI-P4-003