Different Classes of the Antihypertensive TreatmentNCT02604771
Egypt Hypertension Study
An observational study of Different Classes of the Antihypertensive Treatment, run by AstraZeneca at 1 site in Egypt.
Trial summary
This study is an epidemiological non-interventional trial that aims to evaluate standard daily practice in managing patients with arterial hypertension. The trial only records real-life clinical practice with no additional diagnostic or monitoring procedures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Different Classes of the Antihypertensive Treatment
- How many people
- 1,500 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2016to 14 Feb 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be collected from private care clinics.
Who may be able to join
- Males or female aged >21 years
- Subject population with newly diagnosed essential arterial hypertension
- Subject population with essential arterial hypertension currently receiving treatment with any of the following antihypertensive classes: a Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker and Beta Blocker for at least 3 months.
- Females of childbearing potential must use a reliable method of contraception.
- Subject willing to give written informed consent
Who cannot join
- If participating in any clinical trial, the subject cannot take part in this study.
- Pregnancy and lactation.
- Patients not willing to give Informed Consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension
This study is an epidemiological non-interventional trial that aims to evaluate standard daily practice in managing patients with arterial hypertension. The trial only records real-life clinical practice with no additional diagnostic or monitoring procedures.
The study is purposed to collect the following Egypt-specific epidemiology data on hypertension: demographic data, patients' characteristics, and patients' management/treatment in order to reach its rationale.
Read the detailed description
This study is aimed to evaluate response rate of the antihypertensive treatment with Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker, and Beta Blocker in real life practice, and to collect the following Egypt-specific epidemiology data on hypertensive patients: demographic data, patents characteristics, and patients' management/treatment.
Approximately 300 sites will be participating (1 investigator per site; 300 investigators). Patients that are to be enrolled will either be newly diagnosed with hypertension, or on current antihypertensive treatment, compiling a total of 3000 patients (21 years, or older). The study will be conducted in two sequential phases; the first phase will include 150 sites from Cairo, Giza and Alexandria aiming to reach 1500 patients followed by a second phase which will include 150 sites from Delta and Upper Egypt aiming to reach 1500 patients. Epidemiological data collection will take place at a single visit and Laboratory Investigations will be requested in the first visit. Patients will be followed for 3 visits with the investigator. The investigator will complete a Patient Record Form (PRF) with the patient's data: demographics, history, current antihypertensive drug treatment/treatment changes, results of physical examination, blood pressure (SBP/DBP), heart rate.
What is being measured
The primary outcome is the main question the study is designed to answer.
To insert number of hypertensive patients with SBP that are reaching treatment goals
To insert number of patients with Systolic Blood pressure reaching treatment goals according to the ESC 2013 criteria (Systolic blood pressure <140 mmHg* in patients) after being treated with anti-hypertensive medication/s for at least 3 months.
Measured: 12 weeks +- 2
Secondary outcomes (8)
Insert number of patients on antihypertensive pharmacological treatment reaching the DBP goals
Inserting number of SBP patients on antihypertensive treatment reaching the DBP goals according to the Europian Society of Cardiology (ESC) 2013 guidelines.
Measured: 12 +- 2 weeks
Insert number of patients on antihypertensive pharmacological treatment reaching SBP goals
Inserting number of patients on antihypertensive treatment reaching combined SBP \&DBP treatment goals according to Europian Society of Cardiology (ESC) 2013 guidelines.
Measured: 12 +- 2 weeks
Insert epidemiological information on antihypertensive patients in study
- Documenting epidemiological data from the Hypertensive patients during the visit via the investigator asking them and documenting it (Age)
- Documenting any associated major cardiovascular co-morbid diseases by the investigator asking the patient or checking patient history then writing it down in Case Report Form (CRF).
Measured: 12 +- 2 weeks
Insert treatment & managing plan of antihypertensive pharmacological treatment
- Investigator is to document the treatment/management with any changes in it chosen for the patient.
- to document tolerability via questionnaire.
Measured: 12 +- 2 weeks
Insert number of patients on antihypertensive pharmacological treatment reaching DBP goals
Inserting number of patients on antihypertensive treatment reaching combined SBP \&DBP treatment goals according to Europian Society of Cardiology (ESC) 2013 guidelines
Measured: 12+- 2 weeks
Insert epidemiological information on antihypertensive patients in study
- Documenting epidemiological data from the Hypertensive patients during the visit via the investigator asking them and documenting it (Weight)
- Documenting any associated major cardiovascular co-morbid diseases by the investigator asking the patient or checking patient history then writing it down in Case Report Form (CRF).
Measured: 12 +- 2 weeks
Insert epidemiological information on antihypertensive patients in study
- Documenting epidemiological data from the Hypertensive patients during the visit via the investigator asking them and documenting it (gender)
- Documenting any associated major cardiovascular co-morbid diseases by the investigator asking the patient or checking patient history then writing it down in Case Report Form (CRF).
Measured: 12 +- 2 weeks
Insert treatment & managing plan of antihypertensive pharmacological treatment
- Investigator is to document the treatment/management with any changes in it chosen for the patient.
- to document stability of the patient in the Case report form (CRF).
Measured: 12 +- 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start3 Apr 2016
- Primary completion14 Feb 2018
- Study completion14 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Different Classes of the Antihypertensive TreatmentStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohamed A. Saleh, PHD, Principal investigator, Proffessor Cardiology Ain Shams UniversityMohamed Mohsen Ibrahim, PHD, Principal investigator, Cairo UniversityMohamed Awad Taher, PHD, Principal investigator, Ain Shams UniversityKhaled Leon, PHD, Principal investigator, National Heart InstituteAhmed Shawky, PHD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604771
- Sponsor's protocol ID
- D1843R00249
- Status last verified
- Nov 2019
- First submitted
- 18 Aug 2015
- Last updated
- 7 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Epidemiological Study to Evaluate Standard Daily Practice in Managing Patients With Arterial Hypertension
- ClinicalTrials.gov ID
- NCT02604771
- Acronym / sponsor ID
- D1843R00249
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2016 (actual)
- Primary completion
- 14 Feb 2018 (actual)
- Study completion
- 14 Feb 2018 (actual)
- First posted
- 13 Nov 2015 (estimated)
- 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.
This study is an epidemiological non-interventional trial that aims to evaluate standard daily practice in managing patients with arterial hypertension. The trial only records real-life clinical practice with no additional diagnostic or monitoring procedures.
The study is purposed to collect the following Egypt-specific epidemiology data on hypertension: demographic data, patients' characteristics, and patients' management/treatment in order to reach its rationale.
Detailed description
This study is aimed to evaluate response rate of the antihypertensive treatment with Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker, and Beta Blocker in real life practice, and to collect the following Egypt-specific epidemiology data on hypertensive patients: demographic data, patents characteristics, and patients' management/treatment.
Approximately 300 sites will be participating (1 investigator per site; 300 investigators). Patients that are to be enrolled will either be newly diagnosed with hypertension, or on current antihypertensive treatment, compiling a total of 3000 patients (21 years, or older). The study will be conducted in two sequential phases; the first phase will include 150 sites from Cairo, Giza and Alexandria aiming to reach 1500 patients followed by a second phase which will include 150 sites from Delta and Upper Egypt aiming to reach 1500 patients. Epidemiological data collection will take place at a single visit and Laboratory Investigations will be requested in the first visit. Patients will be followed for 3 visits with the investigator. The investigator will complete a Patient Record Form (PRF) with the patient's data: demographics, history, current antihypertensive drug treatment/treatment changes, results of physical examination, blood pressure (SBP/DBP), heart rate.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be collected from private care clinics.
Key inclusion criteria (5 listed)
- Males or female aged >21 years
- Subject population with newly diagnosed essential arterial hypertension
- Subject population with essential arterial hypertension currently receiving treatment with any of the following antihypertensive classes: a Thiazide Diuretics, calcium antagonist, Angiotensin Converting enzyme Inhibitor, Angiotensin II receptor blocker and Beta Blocker for at least 3 months.
- Females of childbearing potential must use a reliable method of contraception.
- Subject willing to give written informed consent
Key exclusion criteria (3 listed)
- If participating in any clinical trial, the subject cannot take part in this study.
- Pregnancy and lactation.
- Patients not willing to give Informed Consent.
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
To insert number of hypertensive patients with SBP that are reaching treatment goals
Time frame: 12 weeks +- 2
To insert number of patients with Systolic Blood pressure reaching treatment goals according to the ESC 2013 criteria (Systolic blood pressure <140 mmHg* in patients) after being treated with anti-hypertensive medication/s for at least 3 months.
8 secondary outcomes
Insert number of patients on antihypertensive pharmacological treatment reaching the DBP goals
Time frame: 12 +- 2 weeks
Insert number of patients on antihypertensive pharmacological treatment reaching SBP goals
Time frame: 12 +- 2 weeks
Insert epidemiological information on antihypertensive patients in study
Time frame: 12 +- 2 weeks
Insert treatment & managing plan of antihypertensive pharmacological treatment
Time frame: 12 +- 2 weeks
Insert number of patients on antihypertensive pharmacological treatment reaching DBP goals
Time frame: 12+- 2 weeks
Insert epidemiological information on antihypertensive patients in study
Time frame: 12 +- 2 weeks
Insert epidemiological information on antihypertensive patients in study
Time frame: 12 +- 2 weeks
Insert treatment & managing plan of antihypertensive pharmacological treatment
Time frame: 12 +- 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2019.
- CSR SynopsisLink provided by the sponsor.
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.
Mohamed A. Saleh, PHD principal investigator
Proffessor Cardiology Ain Shams University
Mohamed Mohsen Ibrahim, PHD principal investigator
Cairo University
Mohamed Awad Taher, PHD principal investigator
Ain Shams University
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 Different Classes of the Antihypertensive Treatment, run by AstraZeneca at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 7 Nov 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To insert number of hypertensive patients with SBP that are reaching treatment goals (time frame: 12 weeks +- 2). 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 7 Nov 2019.