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 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
- ClinicalTrials.govNCT07090161Abrir este registro en ClinicalTrials.govSincronizado hace 2 meses
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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.
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
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
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
| Sexo | Todos |
|---|---|
| Edades | 18 Years – 65 Years |
| Voluntarios sanos | No |
Elegibilidad tal como figura en el registro
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
| Tipo de estudio | De intervención |
|---|---|
| Fase | Fase 2 |
| Asignación | Aleatorizado |
| Modelo de intervención | PARALLEL |
| Propósito principal | TREATMENT |
| Enmascaramiento | QUADRUPLE (4) |
| Inscripción | 240 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
Variable de resultado principal
Change from baseline to treatment week 4 in SiSBP
Plazo screening to treatment week 4
Fechas
| Fecha de inicio | 15 de septiembre de 2025 (real) |
|---|---|
| Finalización principal | 1 de octubre de 2026 (estimada) |
| Finalización | 1 de noviembre de 2026 (estimada) |
| Primera publicación | 29 de julio de 2025 (real) |
| Última actualización | 27 de febrero de 2026 |
| Resultados publicados | No indicado en el registro |
| Estado verificado por última vez | enero 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
| Centro | Ciudad | Estado o región | Estado |
|---|---|---|---|
| Vanda Investigative Site | Burke | Virginia | En reclutamiento |
| Vanda Investigative Site | Carrollton | Texas | Aún no recluta |
| Vanda Investigative Site | Charleston | South Carolina | En reclutamiento |
| Vanda Investigative Site | Chula Vista | California | En reclutamiento |
| Vanda Investigative Site | Cincinnati | Ohio | En reclutamiento |
| Vanda Investigative Site | Columbus | Georgia | En reclutamiento |
| Vanda Investigative Site | Doral | Florida | Aún no recluta |
| Vanda Investigative Site | Dublin | California | En reclutamiento |
| Vanda Investigative Site | El Dorado | Kansas | En reclutamiento |
| Vanda Investigative Site | Fort Myers | Florida | En reclutamiento |
| Vanda Investigative Site | Hazelwood | Missouri | En reclutamiento |
| Vanda Investigative Site | Kinston | North Carolina | En reclutamiento |
| Vanda Investigative Site | Las Vegas | Nevada | Aún no recluta |
| Vanda Investigative Site | Lexington | Kentucky | En reclutamiento |
| Vanda Investigative Site | Mount Kisco | New York | Aún no recluta |
| Vanda Investigative Site | Norfolk | Virginia | En reclutamiento |
| Vanda Investigative Site | Norman | Oklahoma | En reclutamiento |
| Vanda Investigative Site | Oak Brook | Illinois | En reclutamiento |
| Vanda Investigative Site | Oklahoma City | Oklahoma | Aún no recluta |
| Vanda Investigative Site | Phoenix | Arizona | Aún no recluta |
| Vanda Investigative Site | Rochester | New York | Aún no recluta |
| Vanda Investigative Site | Salt Lake City | Utah | Aún no recluta |
| Vanda Investigative Site | Tempe | Arizona | En reclutamiento |
| Vanda Investigative Site | Tinley Park | Illinois | En reclutamiento |
| Vanda Investigative Site | Tucson | Arizona | Aún no recluta |
| Vanda Investigative Site | Valencia | California | Aún no recluta |
| Vanda Investigative Site | Walnut Creek | California | En reclutamiento |
| Vanda Investigative Site | Wichita | Kansas | En 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.