Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
NCT ID: NCT02853045
Last Updated: 2021-09-24
Study Results
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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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2015-06-11
2021-03-10
Brief Summary
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Clinical validation studies could be better to convince users and prescribers than pharmacologic validation only.
A pragmatic study to evaluate generic anti-hypertensive efficacy is proposed. It takes place in real conditions of care for hypertensive patients, for a manometer control criteria.
The aim of the study is to test the hypothesis of non-inferiority for generic anti-hypertensive for blood pressure control.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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period with drug (trade name) then period with generic
Period of 6 weeks.
period with drug (trade name) then period with generic
The list of drugs is detailed in the "study description"
period with generic then period with drug (trade name)
Period of 6 weeks.
period with generic then period with drug (trade name)
The list of drugs is detailed in the "study description"
Interventions
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period with drug (trade name) then period with generic
The list of drugs is detailed in the "study description"
period with generic then period with drug (trade name)
The list of drugs is detailed in the "study description"
Eligibility Criteria
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Inclusion Criteria
* Anti-hypertension treatment available in generic form
* Absence of changes in the anti-hypertension treatment during the previous 3 months
Exclusion Criteria
* Patients with cardiac arrhythmia
* Patient refusing ambulatory blood pressure
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Christophe MARIAT, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU de SAINT-ETIENNE
Locations
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CH d'ANNONAY
Annonay, , France
CH de FEURS
Feurs, , France
CH de FIRMINY
Firminy, , France
CH du PUY EN VELAY
Le Puy-en-Velay, , France
CH de MONTBRISON
Montbrison, , France
CH de ROANNE
Roanne, , France
CH de SAINT-CHAMOND
Saint-Chamond, , France
CHU de SAINT-ETIENNE
Saint-Etienne, , France
Countries
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Other Identifiers
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2014-001404-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1408032
Identifier Type: -
Identifier Source: org_study_id
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