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

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ClinicalTrials.gov Identifier: NCT02853045
Recruitment Status : Recruiting
First Posted : August 2, 2016
Last Update Posted : February 5, 2021
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: period with drug (trade name) then period with generic Drug: period with generic then period with drug (trade name) Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Comparison of Blood Pressure Control Achieved in Antihypertensive or Generic Drugs in Moderate to Severe Hypertensive Patients
Actual Study Start Date : June 11, 2015
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : April 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: period with drug (trade name) then period with generic
Period of 6 weeks.
Drug: period with drug (trade name) then period with generic
The list of drugs is detailed in the "study description"

Experimental: period with generic then period with drug (trade name)
Period of 6 weeks.
Drug: period with generic then period with drug (trade name)
The list of drugs is detailed in the "study description"




Primary Outcome Measures :
  1. Measure of systolic blood pressure [ Time Frame: for 24 hours ]
    with holter (ambulatory)


Secondary Outcome Measures :
  1. number of side effects [ Time Frame: at 12 weeks ]
    number of side effects per patient with a questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02853045


Contacts
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Contact: Christophe MARIAT, MD PhD (0)477828739 ext +33 christophe.mariat@chu-st-etienne.fr
Contact: Carine LABRUYERE, CRA (0)477120469 ext +33 carine.labruyere@chu-st-etienne.fr

Locations
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France
CH d'ANNONAY Not yet recruiting
Annonay, France, 07100
Contact: Etienne FAVRE, MD         
CH de FEURS Not yet recruiting
Feurs, France, 42110
Contact: Georges KRUNZYNSKI, MD         
CH de FIRMINY Not yet recruiting
Firminy, France, 42700
Contact: Michel COMBIER, MD         
Sub-Investigator: Frederic CHOMETON, MD         
CH du PUY EN VELAY Not yet recruiting
Le Puy En Velay, France, 43000
Contact: Marc BOUILLER, MD         
CH de MONTBRISON Not yet recruiting
Montbrison, France, 42600
Contact: Rene RICHARD, MD         
CH de ROANNE Not yet recruiting
Roanne, France, 42300
Contact: Olivier DE SAUNIERES, MD         
CH de SAINT-CHAMOND Not yet recruiting
Saint-chamond, France, 42400
Contact: Franck FONTANEY, MD         
CHU de SAINT-ETIENNE Recruiting
Saint-etienne, France, 42000
Contact: Christophe MARIAT, MD PhD    (0)477828739 ext +33    christophe.mariat@chu-st-etienne.fr   
Contact: Carine LABRUYERE, CRA    (0)477120469 ext +33    carine.labruyere@chu-st-etienne.fr   
Sub-Investigator: Damien THIBAUDIN, MD         
Sub-Investigator: Miriana DINIC, MD         
Sub-Investigator: Serge CHARMION, MD         
Sub-Investigator: Nicolas MAILLARD, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Christophe MARIAT, MD PhD CHU de SAINT-ETIENNE
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02853045    
Other Study ID Numbers: 1408032
2014-001404-22 ( EudraCT Number )
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: February 5, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases