NCT04094714

Brief Summary

Epidemiological study (cross-sectional study) in order to determine the patients who present an adequate control of the Blood Pressure (BP), in a population of Colombian patients diagnosed with Arterial Hypertension (AH) and who are under pharmacological treatment.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

June 27, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2019

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

4.4 years

First QC Date

September 13, 2019

Last Update Submit

September 20, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Patients with adequate control of the Blood Pressure (BP)

    Proportion of patients who present an adequate control of the Blood Pressure (BP)

    It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.

Secondary Outcomes (4)

  • Demographic analysis

    It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.

  • Treatment analysis

    It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.

  • Personal history of diseases

    It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.

  • Adverse Events related with the treatment

    It will be evaluated in each patient (only once, at the time of the interview) throughout the study which is estimated to last 3 years.

Eligibility Criteria

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

Colombian patients

You may qualify if:

  • Age ≥ 18 years
  • Prior diagnosis of Arterial Hypertension (AH) ≥ 3 months before
  • Patients who are under pharmacological treatment of AH ≥ 3 months before

You may not qualify if:

  • The patient has rejected the participation in the study.
  • Patients who, in the judgment of the Investigator, do not understand or are not willing to adequately answer the questions.
  • Mental or psychiatric illness that, in the judgment of the investigator, does not allow adequate information to be obtained.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scandinavia Pharma

Bogotá, 110111, Colombia

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Javier Castillo, Dr

    Scandinavia Pharma

    STUDY DIRECTOR

Central Study Contacts

Javier Castillo, Dr

CONTACT

Ferrari Claudio, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 19, 2019

Study Start

June 27, 2019

Primary Completion

December 1, 2023

Study Completion

July 1, 2024

Last Updated

September 23, 2019

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations