Clinical trial NCT02853045: Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
Official title: Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Measure of systolic blood pressure
timeFrame: for 24 hours
Secondary outcomes:
measure: number of side effects
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Annonay
country: France
facility: CH d'ANNONAY
city: Feurs
country: France
facility: CH de FEURS
city: Firminy
country: France
facility: CH de FIRMINY
city: Le Puy En Velay
country: France
facility: CH du PUY EN VELAY
city: Montbrison
country: France
facility: CH de MONTBRISON
city: Roanne
country: France
facility: CH de ROANNE
city: Saint-chamond
country: France
facility: CH de SAINT-CHAMOND
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Christophe MARIAT, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: