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

NCT ID: NCT02853045

Last Updated: 2021-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-11

Study Completion Date

2021-03-10

Brief Summary

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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

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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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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period with drug (trade name) then period with generic

Period of 6 weeks.

Group Type EXPERIMENTAL

period with drug (trade name) then period with generic

Intervention Type DRUG

The list of drugs is detailed in the "study description"

period with generic then period with drug (trade name)

Period of 6 weeks.

Group Type EXPERIMENTAL

period with generic then period with drug (trade name)

Intervention Type DRUG

The list of drugs is detailed in the "study description"

Interventions

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period with drug (trade name) then period with generic

The list of drugs is detailed in the "study description"

Intervention Type DRUG

period with generic then period with drug (trade name)

The list of drugs is detailed in the "study description"

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christophe MARIAT, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de SAINT-ETIENNE

Locations

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CH d'ANNONAY

Annonay, , France

Site Status

CH de FEURS

Feurs, , France

Site Status

CH de FIRMINY

Firminy, , France

Site Status

CH du PUY EN VELAY

Le Puy-en-Velay, , France

Site Status

CH de MONTBRISON

Montbrison, , France

Site Status

CH de ROANNE

Roanne, , France

Site Status

CH de SAINT-CHAMOND

Saint-Chamond, , France

Site Status

CHU de SAINT-ETIENNE

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2014-001404-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1408032

Identifier Type: -

Identifier Source: org_study_id

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