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NCT07090161ClinicalTrials.gov

Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension

En recrutementAccepte des participants actuellement, selon la fiche du registre.
Contacter cette étude

En bref

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension

Phase 2240 participants recherchés28 sites1 pays

Catégories

Enregistré dans 1 registre

Une même étude peut être enregistrée dans plusieurs registres. Nous l'affichons une seule fois et renvoyons vers chaque fiche que nous détenons.

Les informations de l'essai sont affichées telles que publiées par le registre, dans leur langue d'origine.

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How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Present: Registered before enrolment beganFirst posted 2025-07-29; recorded start 2025-09-15
  • Present: Has a defined primary outcomeA primary outcome measure is listed in the record
  • Present: The primary outcome states a time frameThe primary outcome measure records a time frame
  • Present: Participants are randomly assignedAllocation is recorded as randomised
  • Present: Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Present: Uses blinding (masking)A masking level is recorded in the record
  • Not stated: An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Not stated: Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • Not stated: A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • Present: No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Present: Sponsor has 28 other studies in this databaseCounted from the lead sponsor named in the record (Vanda Pharmaceuticals)
  • Not stated: No posted results from this sponsor are in this database yetBased on the sponsor’s studies in this database
  • The record lists 2 conditions.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 28 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 240 participants (target), run at 28 sites.

How this score is built
  • Enrolment23/40

    240 participants (target)

  • Site count17/25

    28 sites

  • Country count0/15

    Single country

  • Planned duration5/10

    Planned over about 14 months

  • Sponsor scale5/10

    Vanda Pharmaceuticals has led 29 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

Résumé

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension

Affections

  • Hypertension
  • Uncontrolled Hypertension

Éligibilité

Éligibilité
SexeTous
Âges18 Years65 Years
Volontaires sainsNon

Éligibilité telle qu'elle figure dans le registre

Inclusion Criteria: * SiSBP \>/= 130 mmHg despite \>8 weeks treatment w/ 1 or more antihypertensive therapies Exclusion Criteria: * Confirmed Grade 3/severe hypertension (SiSBP \>/= 180 mmHg, SiDBP \>/= 120 mmHg), unstable cardiac disease, renal insufficiency

Éligibilité en énoncés simples

Les critères de cette fiche n'ont pas encore été décomposés en énoncés distincts. Le texte du registre ci-dessus est complet et fait foi.

Conception de l'étude

Conception de l'étude
Type d'étudeInterventionnelle
PhasePhase 2
RépartitionRandomisée
Modèle d'interventionPARALLEL
Objectif principalTREATMENT
InsuQUADRUPLE (4)
Recrutement240 participants recherchés

Promoteur et collaborateurs

  • Vanda Pharmaceuticals Promoteur

Groupes et interventions

  • Experimental/IloperidoneEXPERIMENTAL
  • Placebo ComparatorPLACEBO_COMPARATOR

Interventions

  • Médicament Placebo

    placebo comparator

  • Médicament iloperidone

    iloperidone

Critères de jugement

  1. Critère de jugement principal

    Change from baseline to treatment week 4 in SiSBP

    Délai screening to treatment week 4

Dates

Dates
Date de début15 septembre 2025 (réelle)
Achèvement principal1 octobre 2026 (estimée)
Achèvement1 novembre 2026 (estimée)
Première publication29 juillet 2025 (réelle)
Dernière mise à jour27 février 2026
Résultats publiésNon précisé dans la fiche du registre
Statut vérifié pour la dernière foisjanvier 2026

Réelle signifie que l'événement a eu lieu. Estimée signifie que le promoteur s'y attend. Les deux ont un sens différent.

Lieux

18 sites sont en recrutement

United States

United States
ÉtablissementVilleÉtat ou régionStatut
Vanda Investigative SiteBurkeVirginiaEn recrutement
Vanda Investigative SiteCarrolltonTexasPas encore en recrutement
Vanda Investigative SiteCharlestonSouth CarolinaEn recrutement
Vanda Investigative SiteChula VistaCaliforniaEn recrutement
Vanda Investigative SiteCincinnatiOhioEn recrutement
Vanda Investigative SiteColumbusGeorgiaEn recrutement
Vanda Investigative SiteDoralFloridaPas encore en recrutement
Vanda Investigative SiteDublinCaliforniaEn recrutement
Vanda Investigative SiteEl DoradoKansasEn recrutement
Vanda Investigative SiteFort MyersFloridaEn recrutement
Vanda Investigative SiteHazelwoodMissouriEn recrutement
Vanda Investigative SiteKinstonNorth CarolinaEn recrutement
Vanda Investigative SiteLas VegasNevadaPas encore en recrutement
Vanda Investigative SiteLexingtonKentuckyEn recrutement
Vanda Investigative SiteMount KiscoNew YorkPas encore en recrutement
Vanda Investigative SiteNorfolkVirginiaEn recrutement
Vanda Investigative SiteNormanOklahomaEn recrutement
Vanda Investigative SiteOak BrookIllinoisEn recrutement
Vanda Investigative SiteOklahoma CityOklahomaPas encore en recrutement
Vanda Investigative SitePhoenixArizonaPas encore en recrutement
Vanda Investigative SiteRochesterNew YorkPas encore en recrutement
Vanda Investigative SiteSalt Lake CityUtahPas encore en recrutement
Vanda Investigative SiteTempeArizonaEn recrutement
Vanda Investigative SiteTinley ParkIllinoisEn recrutement
Vanda Investigative SiteTucsonArizonaPas encore en recrutement
Vanda Investigative SiteValenciaCaliforniaPas encore en recrutement
Vanda Investigative SiteWalnut CreekCaliforniaEn recrutement
Vanda Investigative SiteWichitaKansasEn recrutement

Documents de l'étude

Aucun document n'est lié dans cette fiche du registre.

Évolution au fil du temps

Aucun changement n'a été enregistré depuis que nous avons intégré cette fiche pour la première fois.

Un changement est enregistré chaque fois que le promoteur met à jour la fiche du registre. Le statut, les dates, le recrutement et les sites apparaissent ici au fur et à mesure de leur évolution.