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NCT02853045 Clinical Trial

Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

Hypertension Clinical Trial

— PRINGEN  

Official title:
Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02853045
Other study ID # 1408032
Secondary ID 2014-001404-22
Status Completed
Phase Phase 4
First received
Last updated
Start date June 11, 2015
Est. completion date March 10, 2021

Study information
Verified date September 2021
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

List of drugs : ALDACTONE, FLUMACH, SPIROCTAN, SPIRONONE, FLUDEX, INDATEN, LASILIX, TENSTATEN, ALDACTAZINE, PRINACTIZIDE, SPIROCTAZINE, MODURETIC, AVLOCARDYL, HEMIPRALON, STHASIN, BETATOP, TENORMINE, CELECTOL, DETENSIEL, FELSAN, KERLONE, RAGON, RONALOL, LOPRESSOR, SELOKEN, NEBILOX, TEMERIT, NEVEROL, SECTRAL, ACUITEL, KOREC, BRIEM, CIBACENE, COVERSYL, CAPTOLANE, LOPRIL, FOZITEC, ODRIK, GOPTEN, PRINIVIL, ZESTRIL, RENITEC, TEOULA, ZOFENIL, TRIATEC, KENOMON, ADALATE, CHRONOADALATE, AMLOR, BAYPRESS, DELTAZEN, DILRENE, DIACOR, MONO TILDIEM, FLODIL, IPERTEN, ISOPTINE, LERCAN, ZANIDIP, LEDELCARBERDIPE, LENIBERCARDIPE, DIBERLEPIDINE, XILERMIS, APROVEL, CRISARTERS, IFIRMASTA, FLUPPE, ZELMIRB, ATACAND, KENZEN, KARBIS, COZAAR, LOBERASNAT, LOTANBERSAR, MICARDIS, PRITOR, TOLURA, ZANACODAR, DINORTES, MIRPRESOC, NISIS, TAREG, CUENCA, TIFIVAL, VAGRECOR, VAMADRID, HYPERIUM, PHYSIOTENS, BIPRETERAX, PRETERAX, LODOZ, WYTENS, ACUILIX, KORETIC, BRIAZIDE, CIBADREX, CAPTEA, ECAZIDE, CORENITEC, ENALAVIS, ENALURETIC, COTRIATEC, RADOUCHE, FOZIRETIC, PRINZIDE, ZESTORETIC, COAPROVEL, IFIRMACOMBI, COCRISARTERS, COKENZEN, HYTACAND, COANHYVA, COHESAN , COTAREG, NISISCO, FORTZAAR, HYZAAR, MICARDISPLUS, PRITORPLUS, MARESSI, TOLUCOMBI, TENORDATE, BETA ADALATE

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 10, 2021
Est. primary completion date March 10, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Patients on dialysis - Patients with cardiac arrhythmia - Patient refusing ambulatory blood pressure

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 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"

Locations
Country Name City State
France 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

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of systolic blood pressure with holter (ambulatory) for 24 hours
Secondary number of side effects number of side effects per patient with a questionnaire at 12 weeks
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