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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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29 May 2023 |
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Main ID: |
ISRCTN14491942 |
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Date of registration:
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14/04/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of achieved blood pressure control with more than one antihypertensive drug in patients treated by general practitioners in Belgium
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Scientific title:
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Cross-sectional survey evaluating blood pressure target ACHIEVEment in the Belgian general hypertensive population treated with multiple anti-hypertensive agents according to the treatment received |
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Date of first enrolment:
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19/01/2015 |
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Target sample size:
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10000 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN14491942 |
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Study type:
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Observational |
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Study design:
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Cross-sectional observational study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Bregt
Van Nieuwenhuyse |
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Address:
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Servier BeLux
Internationalelaan 57
1070
Anderlecht
Belgium |
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Telephone:
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Email:
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Affiliation:
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Name:
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Valerie
Pauwels |
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Address:
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Servier BeLux
Internationalelaan 57
1070
Anderlecht
Belgium |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All hypertensive patients treated with more than one antihypertensive drug consulting a general practitioner
Exclusion criteria: No exclusion criteria
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
Circulatory System
Hypertension
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Intervention(s)
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Participants attend an appointment to see their general practitioner, who is asked to record the following information:
1. Age and sex of the patient
2. Presence of comorbidities (specify: diabetes, prior CV complications, renal insufficiency, or other)
3. Systolic and diastolic blood pressure
4. Is the patient controlled: Yes or No
5. Current antihypertensive treatment (free associations and/or fixed associations)
6. If the patients is not treated with a fixed association, would you switch them on: fixed bitherapy: Yes or No? // fixe tritherapy: Yes or No?
6.1. If Yes, for which reason?: better compliance?/Better blood pressure control?/better prognosis?/other?
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Primary Outcome(s)
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Systolic and diastolic blood pressure is measured according to clinical practice during cabinet visit
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Secondary Outcome(s)
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1. Isolated systolic hypertension is calculated based on blood pressure measurement according to clinical practice during cabinet visit
2. Judged blood pressure control is written down in CRF by treating general practitioner during cabinet visit
3. Blood pressure control according to ESH/ESC guidelines is evaluated in comparison with blood pressure measurement according to clinical practice during cabinet visit
4. Number of antihypertensive drugs is written down in CRF by treating general practitioner during cabinet visit
5. Type of antihypertensive associations used (free, fixed or mixed) is written down in CRF by treating general practitioner during cabinet visit
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Secondary ID(s)
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Visa Pharma.be: VI 14/10/06/01
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Source(s) of Monetary Support
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Servier BeLux
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Ethics review
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Status:
Approval date:
Contact:
Due to the observational nature of this study, it does not require ethics approval according to the European directive and Belgian law. Nonetheless, the study has been approved by pharma.be (Bureau Des Visas Études Scientifiques Décision) on 16/10/2014 (dossier 14/10/06/01)
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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14/09/2016 |
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URL:
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