CHACO Study: Control of Arterial Hypertension in Colombian Patients

Hypertension Clinical Trial

— CHACO  

Official title:

CHACO Study: Control of Arterial Hypertension in Colombian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04094714
• Other study ID #: CHACO
• Status: Recruiting
• Start date: June 27, 2019
• Est. completion date: July 2024

Study information

• Verified date: September 2019
• Source: Scandinavia Pharma
• Contact: Javier Castillo, Dr
• Phone: +571-6461700
• Email: jcastill[@]scandinavia.com.co
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1100
• Est. completion date: July 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension

Locations

Country	Name	City	State
Colombia	Scandinavia Pharma	Bogotá

Sponsors (1)

Lead Sponsor	Collaborator
Scandinavia Pharma

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Demographic analysis	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.
Secondary	Treatment analysis	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.
Secondary	Personal history of diseases	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.
Secondary	Adverse Events related with the treatment	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.