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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

In reclutamentoAccetta partecipanti ora, secondo la scheda del registro.
Contatta questo studio

In breve

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 partecipanti ricercati28 centri1 paese

Categorie

Registrato in 1 registro

Uno studio può essere registrato in più registri. Lo mostriamo una volta sola e colleghiamo ogni scheda in nostro possesso.

Le informazioni sulla sperimentazione sono mostrate così come pubblicate dal registro, nella lingua originale.

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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.

Sintesi

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

Patologie

  • Hypertension
  • Uncontrolled Hypertension

Idoneità

Idoneità
SessoTutti
Età18 Years65 Years
Volontari saniNo

Idoneità come riportata nel 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

Idoneità in frasi semplici

I criteri di questa scheda non sono ancora stati suddivisi in affermazioni distinte. Il testo del registro qui sopra è completo ed è la versione autorevole.

Disegno dello studio

Disegno dello studio
Tipo di studioInterventistico
FaseFase 2
AssegnazioneRandomizzata
Modello di interventoPARALLEL
Finalità principaleTREATMENT
MascheramentoQUADRUPLE (4)
Arruolamento240 partecipanti ricercati

Sponsor e collaboratori

  • Vanda Pharmaceuticals Sponsor

Bracci e interventi

  • Experimental/IloperidoneEXPERIMENTAL
  • Placebo ComparatorPLACEBO_COMPARATOR

Interventi

  • Farmaco Placebo

    placebo comparator

  • Farmaco iloperidone

    iloperidone

Esiti misurati

  1. Esito primario

    Change from baseline to treatment week 4 in SiSBP

    Orizzonte temporale screening to treatment week 4

Date

Date
Data di inizio15 settembre 2025 (effettiva)
Conclusione primaria1 ottobre 2026 (stimata)
Conclusione1 novembre 2026 (stimata)
Prima pubblicazione29 luglio 2025 (effettiva)
Ultimo aggiornamento27 febbraio 2026
Risultati pubblicatiNon indicato nella scheda del registro
Stato verificato l'ultima voltagennaio 2026

«Effettiva» significa che l'evento è avvenuto. «Stimata» significa che lo sponsor lo prevede. Le due cose non sono equivalenti.

Centri

18 centri stanno reclutando

United States

United States
StrutturaCittàStato o regioneStato
Vanda Investigative SiteBurkeVirginiaIn reclutamento
Vanda Investigative SiteCarrolltonTexasNon ancora in reclutamento
Vanda Investigative SiteCharlestonSouth CarolinaIn reclutamento
Vanda Investigative SiteChula VistaCaliforniaIn reclutamento
Vanda Investigative SiteCincinnatiOhioIn reclutamento
Vanda Investigative SiteColumbusGeorgiaIn reclutamento
Vanda Investigative SiteDoralFloridaNon ancora in reclutamento
Vanda Investigative SiteDublinCaliforniaIn reclutamento
Vanda Investigative SiteEl DoradoKansasIn reclutamento
Vanda Investigative SiteFort MyersFloridaIn reclutamento
Vanda Investigative SiteHazelwoodMissouriIn reclutamento
Vanda Investigative SiteKinstonNorth CarolinaIn reclutamento
Vanda Investigative SiteLas VegasNevadaNon ancora in reclutamento
Vanda Investigative SiteLexingtonKentuckyIn reclutamento
Vanda Investigative SiteMount KiscoNew YorkNon ancora in reclutamento
Vanda Investigative SiteNorfolkVirginiaIn reclutamento
Vanda Investigative SiteNormanOklahomaIn reclutamento
Vanda Investigative SiteOak BrookIllinoisIn reclutamento
Vanda Investigative SiteOklahoma CityOklahomaNon ancora in reclutamento
Vanda Investigative SitePhoenixArizonaNon ancora in reclutamento
Vanda Investigative SiteRochesterNew YorkNon ancora in reclutamento
Vanda Investigative SiteSalt Lake CityUtahNon ancora in reclutamento
Vanda Investigative SiteTempeArizonaIn reclutamento
Vanda Investigative SiteTinley ParkIllinoisIn reclutamento
Vanda Investigative SiteTucsonArizonaNon ancora in reclutamento
Vanda Investigative SiteValenciaCaliforniaNon ancora in reclutamento
Vanda Investigative SiteWalnut CreekCaliforniaIn reclutamento
Vanda Investigative SiteWichitaKansasIn reclutamento

Documenti dello studio

In questa scheda del registro non sono collegati documenti.

Modifiche nel tempo

Non è stata registrata alcuna modifica da quando abbiamo acquisito questa scheda.

Viene registrata una modifica ogni volta che lo sponsor aggiorna la scheda del registro. Stato, date, arruolamento e centri compaiono qui man mano che cambiano.