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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

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En resumen

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

Fase 2240 participantes buscados28 centros1 país

Categorías

Registrado en 1 registro

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La información del ensayo se muestra tal como la publicó el registro, en su idioma original.

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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.

Resumen

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

Afecciones

  • Hypertension
  • Uncontrolled Hypertension

Elegibilidad

Elegibilidad
SexoTodos
Edades18 Years65 Years
Voluntarios sanosNo

Elegibilidad tal como figura en el registro

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

Elegibilidad en frases sencillas

Los criterios de este registro aún no se han desglosado en frases separadas. El texto del registro anterior está completo y es la versión autorizada.

Diseño del estudio

Diseño del estudio
Tipo de estudioDe intervención
FaseFase 2
AsignaciónAleatorizado
Modelo de intervenciónPARALLEL
Propósito principalTREATMENT
EnmascaramientoQUADRUPLE (4)
Inscripción240 participantes buscados

Patrocinador y colaboradores

  • Vanda Pharmaceuticals Patrocinador

Grupos e intervenciones

  • Experimental/IloperidoneEXPERIMENTAL
  • Placebo ComparatorPLACEBO_COMPARATOR

Intervenciones

  • Fármaco Placebo

    placebo comparator

  • Fármaco iloperidone

    iloperidone

Variables de resultado

  1. Variable de resultado principal

    Change from baseline to treatment week 4 in SiSBP

    Plazo screening to treatment week 4

Fechas

Fechas
Fecha de inicio15 de septiembre de 2025 (real)
Finalización principal1 de octubre de 2026 (estimada)
Finalización1 de noviembre de 2026 (estimada)
Primera publicación29 de julio de 2025 (real)
Última actualización27 de febrero de 2026
Resultados publicadosNo indicado en el registro
Estado verificado por última vezenero de 2026

Real significa que el evento ocurrió. Estimada significa que el patrocinador lo prevé. Ambas cosas significan algo distinto.

Ubicaciones

18 centros están en reclutamiento

United States

United States
CentroCiudadEstado o regiónEstado
Vanda Investigative SiteBurkeVirginiaEn reclutamiento
Vanda Investigative SiteCarrolltonTexasAún no recluta
Vanda Investigative SiteCharlestonSouth CarolinaEn reclutamiento
Vanda Investigative SiteChula VistaCaliforniaEn reclutamiento
Vanda Investigative SiteCincinnatiOhioEn reclutamiento
Vanda Investigative SiteColumbusGeorgiaEn reclutamiento
Vanda Investigative SiteDoralFloridaAún no recluta
Vanda Investigative SiteDublinCaliforniaEn reclutamiento
Vanda Investigative SiteEl DoradoKansasEn reclutamiento
Vanda Investigative SiteFort MyersFloridaEn reclutamiento
Vanda Investigative SiteHazelwoodMissouriEn reclutamiento
Vanda Investigative SiteKinstonNorth CarolinaEn reclutamiento
Vanda Investigative SiteLas VegasNevadaAún no recluta
Vanda Investigative SiteLexingtonKentuckyEn reclutamiento
Vanda Investigative SiteMount KiscoNew YorkAún no recluta
Vanda Investigative SiteNorfolkVirginiaEn reclutamiento
Vanda Investigative SiteNormanOklahomaEn reclutamiento
Vanda Investigative SiteOak BrookIllinoisEn reclutamiento
Vanda Investigative SiteOklahoma CityOklahomaAún no recluta
Vanda Investigative SitePhoenixArizonaAún no recluta
Vanda Investigative SiteRochesterNew YorkAún no recluta
Vanda Investigative SiteSalt Lake CityUtahAún no recluta
Vanda Investigative SiteTempeArizonaEn reclutamiento
Vanda Investigative SiteTinley ParkIllinoisEn reclutamiento
Vanda Investigative SiteTucsonArizonaAún no recluta
Vanda Investigative SiteValenciaCaliforniaAún no recluta
Vanda Investigative SiteWalnut CreekCaliforniaEn reclutamiento
Vanda Investigative SiteWichitaKansasEn reclutamiento

Documentos del estudio

No hay documentos enlazados en este registro.

Cambios a lo largo del tiempo

No se han registrado cambios desde que incorporamos este registro por primera vez.

Se registra un cambio cada vez que el patrocinador actualiza el registro. El estado, las fechas, la inscripción y los centros aparecen aquí a medida que cambian.