Epidemiological Study in Thai Participants With Hypertension

Hypertension Clinical Trial

Official title:

A Multi-Centre, Non-Interventional, Hospital-Based, Cross-Sectional as Well as Longitudinal Epidemiological Study in Thai Subjects With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02467855
• Other study ID #: AZI-P4-003
• Status: Completed
• Phase: N/A
• First received: April 23, 2015
• Last updated: November 12, 2015
• Start date: October 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Legal Affairs Group, Thai Food and Drug Administration, Ministry of Public Health
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate blood pressure (BP) goal attainment in adult participants with essential hypertension.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2071
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension

Intervention

Other:
• No Intervention
No intervention was administered in this study.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants with Controlled Treated Hypertension		Up to 16 weeks	No
Secondary	Percentage of Participants for Whom Dose of Current Medications was Increased		Up to 16 weeks	No
Secondary	Percentage of Participants for Whom Antihypertensive Medications were Switched		Up to 16 weeks	No
Secondary	Percentage of Participants for Whom Second Antihypertensive Drug was Added		Up to 16 weeks	No
Secondary	Percentage of Participants for Whom One or More of the Compound of Index Treatment was Removed		Up to 16 weeks	No
Secondary	Percentage of Participants in Whom There was No Change in Treatment Regimen		Up to 16 weeks	No
Secondary	Reason for Choosing the Treatment Regimens in Hypertension Treatment		Up to 16 weeks	No
Secondary	Treatment Regimen for Hypertension	Treatment regimen for hypertension will be either monotherapy or combination therapy.	Up to 16 weeks	No
Secondary	Types of Antihypertensive Medications and Medication Classes		Up to 16 weeks	No