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 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
- ClinicalTrials.govNCT07090161Ouvrir cette fiche sur ClinicalTrials.govSynchronisé il y a 2 mois
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.
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.
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
| Sexe | Tous |
|---|---|
| Âges | 18 Years – 65 Years |
| Volontaires sains | Non |
Éligibilité telle qu'elle figure dans le registre
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
| Type d'étude | Interventionnelle |
|---|---|
| Phase | Phase 2 |
| Répartition | Randomisée |
| Modèle d'intervention | PARALLEL |
| Objectif principal | TREATMENT |
| Insu | QUADRUPLE (4) |
| Recrutement | 240 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
Critère de jugement principal
Change from baseline to treatment week 4 in SiSBP
Délai screening to treatment week 4
Dates
| Date de début | 15 septembre 2025 (réelle) |
|---|---|
| Achèvement principal | 1 octobre 2026 (estimée) |
| Achèvement | 1 novembre 2026 (estimée) |
| Première publication | 29 juillet 2025 (réelle) |
| Dernière mise à jour | 27 février 2026 |
| Résultats publiés | Non précisé dans la fiche du registre |
| Statut vérifié pour la dernière fois | janvier 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
| Établissement | Ville | État ou région | Statut |
|---|---|---|---|
| Vanda Investigative Site | Burke | Virginia | En recrutement |
| Vanda Investigative Site | Carrollton | Texas | Pas encore en recrutement |
| Vanda Investigative Site | Charleston | South Carolina | En recrutement |
| Vanda Investigative Site | Chula Vista | California | En recrutement |
| Vanda Investigative Site | Cincinnati | Ohio | En recrutement |
| Vanda Investigative Site | Columbus | Georgia | En recrutement |
| Vanda Investigative Site | Doral | Florida | Pas encore en recrutement |
| Vanda Investigative Site | Dublin | California | En recrutement |
| Vanda Investigative Site | El Dorado | Kansas | En recrutement |
| Vanda Investigative Site | Fort Myers | Florida | En recrutement |
| Vanda Investigative Site | Hazelwood | Missouri | En recrutement |
| Vanda Investigative Site | Kinston | North Carolina | En recrutement |
| Vanda Investigative Site | Las Vegas | Nevada | Pas encore en recrutement |
| Vanda Investigative Site | Lexington | Kentucky | En recrutement |
| Vanda Investigative Site | Mount Kisco | New York | Pas encore en recrutement |
| Vanda Investigative Site | Norfolk | Virginia | En recrutement |
| Vanda Investigative Site | Norman | Oklahoma | En recrutement |
| Vanda Investigative Site | Oak Brook | Illinois | En recrutement |
| Vanda Investigative Site | Oklahoma City | Oklahoma | Pas encore en recrutement |
| Vanda Investigative Site | Phoenix | Arizona | Pas encore en recrutement |
| Vanda Investigative Site | Rochester | New York | Pas encore en recrutement |
| Vanda Investigative Site | Salt Lake City | Utah | Pas encore en recrutement |
| Vanda Investigative Site | Tempe | Arizona | En recrutement |
| Vanda Investigative Site | Tinley Park | Illinois | En recrutement |
| Vanda Investigative Site | Tucson | Arizona | Pas encore en recrutement |
| Vanda Investigative Site | Valencia | California | Pas encore en recrutement |
| Vanda Investigative Site | Walnut Creek | California | En recrutement |
| Vanda Investigative Site | Wichita | Kansas | En 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.