Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
NCT02853045 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2021-09-24
Summary
Despite a large diffusion for generic anti-hypertensive, they are not currently used.
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.
Conditions
Interventions
- DRUG
-
period with drug (trade name) then period with generic
The list of drugs is detailed in the "study description"
- DRUG
-
period with generic then period with drug (trade name)
The list of drugs is detailed in the "study description"
Sponsors & Collaborators
-
Centre Hospitalier Universitaire de Saint Etienne
lead OTHER
Principal Investigators
-
Christophe MARIAT, MD PhD · CHU de SAINT-ETIENNE
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-06-11
- Primary Completion
- 2021-03-10
- Completion
- 2021-03-10
Countries
- France
Study Locations
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