HypertensionCHACONCT04094714
CHACO Study: Control of Arterial Hypertension in Colombian Patients
An observational study of Hypertension, run by Scandinavia Pharma at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- How many people
- 1,100 participants
- Where
- 1 siteColombia
- Study dates
- 27 Jun 2019to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colombian patients
Who may be able to join
- Age ≥ 18 years
- Prior diagnosis of Arterial Hypertension (AH) ≥ 3 months before
- Patients who are under pharmacological treatment of AH ≥ 3 months before
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Colombia1 site, 1 recruiting
- Recruiting
Scandinavia Pharma
Bogotá, 110111
Javier Castillo, Dr, +571-6461700, jcastill@scandinavia.com.co
About this study
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.
Read the 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%.
- Conditions
- Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with adequate control of the Blood Pressure (BP)
Proportion of patients who present an adequate control of the Blood Pressure (BP)
Measured: 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
Characterization of patients
Measured: 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
Characterization of treatment (s) used
Measured: 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
Evaluation of personal history of diseases
Measured: 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
Adverse events associated with the treatment (s)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start27 Jun 2019
- Primary completionDec 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Scandinavia Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Javier Castillo, Dr, Study director, Scandinavia Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094714
- Sponsor's protocol ID
- CHACO
- Acronym
- CHACO
- Status last verified
- Sep 2019
- First submitted
- 13 Sep 2019
- Last updated
- 23 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHACO Study: Control of Arterial Hypertension in Colombian Patients
- ClinicalTrials.gov ID
- NCT04094714
- Acronym / sponsor ID
- CHACO / CHACO
- Conditions
- Hypertension
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Scandinavia PharmaIndustry (pharma, biotech, devices)
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colombian patients
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Prior diagnosis of Arterial Hypertension (AH) ≥ 3 months before
- Patients who are under pharmacological treatment of AH ≥ 3 months before
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
4 secondary outcomes
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Castillo, Dr study director
Scandinavia Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Scandinavia Pharma at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Castillo, Dr (+571-6461700, jcastill@scandinavia.com.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2019.