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 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
- ClinicalTrials.govNCT07090161Apri questa scheda su ClinicalTrials.govSincronizzato 2 mesi fa
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.
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.
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
| Sesso | Tutti |
|---|---|
| Età | 18 Years – 65 Years |
| Volontari sani | No |
Idoneità come riportata nel registro
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
| Tipo di studio | Interventistico |
|---|---|
| Fase | Fase 2 |
| Assegnazione | Randomizzata |
| Modello di intervento | PARALLEL |
| Finalità principale | TREATMENT |
| Mascheramento | QUADRUPLE (4) |
| Arruolamento | 240 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
Esito primario
Change from baseline to treatment week 4 in SiSBP
Orizzonte temporale screening to treatment week 4
Date
| Data di inizio | 15 settembre 2025 (effettiva) |
|---|---|
| Conclusione primaria | 1 ottobre 2026 (stimata) |
| Conclusione | 1 novembre 2026 (stimata) |
| Prima pubblicazione | 29 luglio 2025 (effettiva) |
| Ultimo aggiornamento | 27 febbraio 2026 |
| Risultati pubblicati | Non indicato nella scheda del registro |
| Stato verificato l'ultima volta | gennaio 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
| Struttura | Città | Stato o regione | Stato |
|---|---|---|---|
| Vanda Investigative Site | Burke | Virginia | In reclutamento |
| Vanda Investigative Site | Carrollton | Texas | Non ancora in reclutamento |
| Vanda Investigative Site | Charleston | South Carolina | In reclutamento |
| Vanda Investigative Site | Chula Vista | California | In reclutamento |
| Vanda Investigative Site | Cincinnati | Ohio | In reclutamento |
| Vanda Investigative Site | Columbus | Georgia | In reclutamento |
| Vanda Investigative Site | Doral | Florida | Non ancora in reclutamento |
| Vanda Investigative Site | Dublin | California | In reclutamento |
| Vanda Investigative Site | El Dorado | Kansas | In reclutamento |
| Vanda Investigative Site | Fort Myers | Florida | In reclutamento |
| Vanda Investigative Site | Hazelwood | Missouri | In reclutamento |
| Vanda Investigative Site | Kinston | North Carolina | In reclutamento |
| Vanda Investigative Site | Las Vegas | Nevada | Non ancora in reclutamento |
| Vanda Investigative Site | Lexington | Kentucky | In reclutamento |
| Vanda Investigative Site | Mount Kisco | New York | Non ancora in reclutamento |
| Vanda Investigative Site | Norfolk | Virginia | In reclutamento |
| Vanda Investigative Site | Norman | Oklahoma | In reclutamento |
| Vanda Investigative Site | Oak Brook | Illinois | In reclutamento |
| Vanda Investigative Site | Oklahoma City | Oklahoma | Non ancora in reclutamento |
| Vanda Investigative Site | Phoenix | Arizona | Non ancora in reclutamento |
| Vanda Investigative Site | Rochester | New York | Non ancora in reclutamento |
| Vanda Investigative Site | Salt Lake City | Utah | Non ancora in reclutamento |
| Vanda Investigative Site | Tempe | Arizona | In reclutamento |
| Vanda Investigative Site | Tinley Park | Illinois | In reclutamento |
| Vanda Investigative Site | Tucson | Arizona | Non ancora in reclutamento |
| Vanda Investigative Site | Valencia | California | Non ancora in reclutamento |
| Vanda Investigative Site | Walnut Creek | California | In reclutamento |
| Vanda Investigative Site | Wichita | Kansas | In 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.