Clinical trial NCT02467855: Epidemiological Study in Thai Participants With Hypertension
Official title: A Multi-Centre, Non-Interventional, Hospital-Based, Cross-Sectional as Well as Longitudinal Epidemiological Study in Thai Subjects With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-06-10
Enrollment: 2071
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with essential hypertension will be enrolled from outpatient hospital departments or hospital clinics in Thailand.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants with Controlled Treated Hypertension
timeFrame: Up to 16 weeks
Secondary outcomes:
measure: Percentage of Participants for Whom Dose of Current Medications was Increased
timeFrame: Up to 16 weeks
measure: Percentage of Participants for Whom Antihypertensive Medications were Switched
timeFrame: Up to 16 weeks
measure: Percentage of Participants for Whom Second Antihypertensive Drug was Added
timeFrame: Up to 16 weeks
measure: Percentage of Participants for Whom One or More of the Compound of Index Treatment was Removed
timeFrame: Up to 16 weeks
measure: Percentage of Participants in Whom There was No Change in Treatment Regimen
timeFrame: Up to 16 weeks
measure: Reason for Choosing the Treatment Regimens in Hypertension Treatment
timeFrame: Up to 16 weeks
measure: Treatment Regimen for Hypertension
timeFrame: Up to 16 weeks
measure: Types of Antihypertensive Medications and Medication Classes
timeFrame: Up to 16 weeks
Other outcomes:
Locations:
city: Pathumwan
country: Thailand
state: Bangkok
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: