Egypt Hypertension Study

NCT ID: NCT02604771

Last Updated: 2019-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-03

Study Completion Date

2018-02-14

Brief Summary

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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

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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.

Conditions

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Different Classes of the Antihypertensive Treatment

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* If participating in any clinical trial, the subject cannot take part in this study.
* Pregnancy and lactation.
* Patients not willing to give Informed Consent.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohamed A. Saleh, PHD

Role: PRINCIPAL_INVESTIGATOR

Proffessor Cardiology Ain Shams University

Mohamed Mohsen Ibrahim, PHD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Mohamed Awad Taher, PHD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Khaled Leon, PHD

Role: PRINCIPAL_INVESTIGATOR

National Heart Institute

Ahmed Shawky, PHD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

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Research Site

Egypt, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Related Links

Other Identifiers

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D1843R00249

Identifier Type: -

Identifier Source: org_study_id

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