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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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 Teilnehmende gesucht28 Studienzentren1 Land
Kategorien
In 1 Register registriert
- ClinicalTrials.govNCT07090161Diesen Eintrag bei ClinicalTrials.gov öffnenSynchronisiert vor 2 Monaten
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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.
Zusammenfassung
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension
Erkrankungen
- Hypertension
- Uncontrolled Hypertension
Eignung
| Geschlecht | Alle |
|---|---|
| Alter | 18 Years – 65 Years |
| Gesunde Freiwillige | Nein |
Eignung im Wortlaut des Registers
Eignung in einfachen Aussagen
Die Kriterien dieses Eintrags wurden noch nicht in einzelne Aussagen aufgeschlüsselt. Der Registertext oben ist vollständig und ist die maßgebliche Fassung.
Studiendesign
| Studientyp | Interventionell |
|---|---|
| Phase | Phase 2 |
| Zuteilung | Randomisiert |
| Interventionsmodell | PARALLEL |
| Primäres Ziel | TREATMENT |
| Verblindung | QUADRUPLE (4) |
| Teilnahme | 240 Teilnehmende gesucht |
Sponsor und Mitwirkende
- Vanda Pharmaceuticals Sponsor
Studienarme und Interventionen
- Experimental/IloperidoneEXPERIMENTAL
- Placebo ComparatorPLACEBO_COMPARATOR
Interventionen
- Arzneimittel Placebo
placebo comparator
- Arzneimittel iloperidone
iloperidone
Endpunkte
Primärer Endpunkt
Change from baseline to treatment week 4 in SiSBP
Zeitrahmen screening to treatment week 4
Daten
| Startdatum | 15. September 2025 (tatsächlich) |
|---|---|
| Primärer Abschluss | 1. Oktober 2026 (geschätzt) |
| Abschluss | 1. November 2026 (geschätzt) |
| Erstveröffentlichung | 29. Juli 2025 (tatsächlich) |
| Zuletzt aktualisiert | 27. Februar 2026 |
| Ergebnisse veröffentlicht | Im Registereintrag nicht angegeben |
| Status zuletzt bestätigt | Januar 2026 |
Tatsächlich bedeutet, dass das Ereignis eingetreten ist. Geschätzt bedeutet, dass der Sponsor es erwartet. Die beiden bedeuten Unterschiedliches.
Standorte
18 Studienzentren rekrutieren
United States
| Einrichtung | Stadt | Bundesland oder Region | Status |
|---|---|---|---|
| Vanda Investigative Site | Burke | Virginia | Rekrutiert |
| Vanda Investigative Site | Carrollton | Texas | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Charleston | South Carolina | Rekrutiert |
| Vanda Investigative Site | Chula Vista | California | Rekrutiert |
| Vanda Investigative Site | Cincinnati | Ohio | Rekrutiert |
| Vanda Investigative Site | Columbus | Georgia | Rekrutiert |
| Vanda Investigative Site | Doral | Florida | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Dublin | California | Rekrutiert |
| Vanda Investigative Site | El Dorado | Kansas | Rekrutiert |
| Vanda Investigative Site | Fort Myers | Florida | Rekrutiert |
| Vanda Investigative Site | Hazelwood | Missouri | Rekrutiert |
| Vanda Investigative Site | Kinston | North Carolina | Rekrutiert |
| Vanda Investigative Site | Las Vegas | Nevada | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Lexington | Kentucky | Rekrutiert |
| Vanda Investigative Site | Mount Kisco | New York | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Norfolk | Virginia | Rekrutiert |
| Vanda Investigative Site | Norman | Oklahoma | Rekrutiert |
| Vanda Investigative Site | Oak Brook | Illinois | Rekrutiert |
| Vanda Investigative Site | Oklahoma City | Oklahoma | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Phoenix | Arizona | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Rochester | New York | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Salt Lake City | Utah | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Tempe | Arizona | Rekrutiert |
| Vanda Investigative Site | Tinley Park | Illinois | Rekrutiert |
| Vanda Investigative Site | Tucson | Arizona | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Valencia | California | Rekrutierung noch nicht begonnen |
| Vanda Investigative Site | Walnut Creek | California | Rekrutiert |
| Vanda Investigative Site | Wichita | Kansas | Rekrutiert |
Studiendokumente
In diesem Registereintrag sind keine Dokumente verlinkt.
Änderungen im Zeitverlauf
Seit wir diesen Eintrag erstmals eingelesen haben, wurden keine Änderungen erfasst.
Eine Änderung wird jedes Mal erfasst, wenn der Sponsor den Registereintrag aktualisiert. Status, Daten, Teilnahme und Studienzentren erscheinen hier, sobald sie sich ändern.