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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Drug: period with drug (trade name) then period with generic; Drug: period with generic then period with drug (trade name)

• Registration Number: NCT02853045
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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

Study Timeline

• Study Start: 2015-06-11
• Study First Submitted: 2016-07-06
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Primary Completion: 2021-03-10
• Study Completion: 2021-03-10
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-23
• Last Update Posted: 2021-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
period with drug (trade name) then period with generic	period with drug (trade name) then period with generic	Period of 6 weeks.
period with generic then period with drug (trade name)	period with generic then period with drug (trade name)	Period of 6 weeks.

Primary Outcome Measures

Name	Time	Method
Measure of systolic blood pressure	for 24 hours	with holter (ambulatory)

Secondary Outcome Measures

Name	Time	Method
number of side effects	at 12 weeks	number of side effects per patient with a questionnaire

Trial Locations

Locations (8)

CH d'ANNONAY; 🇫🇷 Annonay, France

CH de MONTBRISON; 🇫🇷 Montbrison, France

CH de FIRMINY; 🇫🇷 Firminy, France

CH du PUY EN VELAY; 🇫🇷 Le Puy En Velay, France

CH de FEURS; 🇫🇷 Feurs, France

CH de ROANNE; 🇫🇷 Roanne, France

CH de SAINT-CHAMOND; 🇫🇷 Saint-chamond, France

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France