NCT02467855

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,071

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 10, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 13, 2015

Status Verified

November 1, 2015

Enrollment Period

10 months

First QC Date

April 23, 2015

Last Update Submit

November 12, 2015

Conditions

Hypertension

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants with Controlled Treated Hypertension

    Up to 16 weeks

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

Cross-Sectional Cohort

Participants receiving standard of care for hypertension with well-controlled hypertension will participate in 1 visit.

Other: No Intervention

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

Interventions

No InterventionOTHER

No intervention was administered in this study.

Also known as: No intervention was administered in this study.
Cross-Sectional CohortLongitudinal Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Pathumwan, Bangkok, Thailand

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Medical Director Clinical Science

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

June 10, 2015

Study Start

October 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 13, 2015

Record last verified: 2015-11

Locations

TH(1)