CHACO Study: Control of Arterial Hypertension in Colombian Patients (CHACO)

September 20, 2019 updated by: Scandinavia Pharma
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

OBJECTIVE: To determine the proportion of 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.

MATERIALS AND METHODS: Epidemiological study (cross-sectional study), multicentre type, in patients older than 18 years with prior diagnosis of AH in Colombia. The blood pressure control will be evaluated as the main variable (only one single blood pressure check in the doctor's office). Other secondary variables to evaluate are: demographical analysis, type (s) of antihypertensive treatment (s) used in patients, level of BP control, adverse events associated with antihypertensive treatment, comorbidities and risk factors, adherence, perception about the possible benefits of the use of combined therapy in "mono-tablet" versus "multi-tablet". The analysis will be carried out from two perspectives: A first descriptive approach and a second analytical approach, with a level of significance of 5%.

Study Type

Observational

Enrollment (Anticipated)

1100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Colombian patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with adequate control of the Blood Pressure (BP)
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic analysis
Time Frame: 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.
Characterization of patients
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
Time Frame: 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.
Characterization of treatment (s) used
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
Time Frame: 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.
Evaluation of 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
Time Frame: 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 associated with the treatment (s)
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Scandinavia Pharma

Investigators

  • Study Director: Javier Castillo, Dr, Scandinavia Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

September 13, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 19, 2019

Study Record Updates

Last Update Posted (Actual)

September 23, 2019

Last Update Submitted That Met QC Criteria

September 20, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHACO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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