Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
PRINGEN
2 other identifiers
interventional
50
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Jun 2015
Longer than P75 for phase_4 hypertension
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 11, 2015
CompletedFirst Submitted
Initial submission to the registry
July 6, 2016
CompletedFirst Posted
Study publicly available on registry
August 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 10, 2021
CompletedSeptember 24, 2021
September 1, 2021
5.8 years
July 6, 2016
September 23, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Measure of systolic blood pressure
with holter (ambulatory)
for 24 hours
Secondary Outcomes (1)
number of side effects
at 12 weeks
Study Arms (2)
period with drug (trade name) then period with generic
EXPERIMENTALPeriod of 6 weeks.
period with generic then period with drug (trade name)
EXPERIMENTALPeriod of 6 weeks.
Interventions
The list of drugs is detailed in the "study description"
The list of drugs is detailed in the "study description"
Eligibility Criteria
You may qualify if:
- hypertensive patient known and treated taking at least two antihypertensive
- Anti-hypertension treatment available in generic form
- Absence of changes in the anti-hypertension treatment during the previous 3 months
You may not qualify if:
- Patients on dialysis
- Patients with cardiac arrhythmia
- Patient refusing ambulatory blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
CH d'ANNONAY
Annonay, 07100, France
CH de FEURS
Feurs, 42110, France
CH de FIRMINY
Firminy, 42700, France
CH du PUY EN VELAY
Le Puy-en-Velay, 43000, France
CH de MONTBRISON
Montbrison, 42600, France
CH de ROANNE
Roanne, 42300, France
CH de SAINT-CHAMOND
Saint-Chamond, 42400, France
CHU de SAINT-ETIENNE
Saint-Etienne, 42000, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christophe MARIAT, MD PhD
CHU de SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2016
First Posted
August 2, 2016
Study Start
June 11, 2015
Primary Completion
March 10, 2021
Study Completion
March 10, 2021
Last Updated
September 24, 2021
Record last verified: 2021-09
Data Sharing
- IPD Sharing
- Will not share