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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

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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

المرحلة 2مطلوب 240 مشاركاً28 موقعاًدولة واحدة

الفئات

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

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.

ملخص

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

الحالات

  • Hypertension
  • Uncontrolled Hypertension

الأهلية

الأهلية
الجنسالجميع
الأعمار18 Years65 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

تصميم الدراسة
نوع الدراسةتدخّلية
المرحلةالمرحلة 2
التخصيصمعشّاة
نموذج التدخّلPARALLEL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 240 مشاركاً

الجهة الراعية والمتعاونون

  • Vanda Pharmaceuticals الجهة الراعية

الأذرع والتدخلات

  • Experimental/IloperidoneEXPERIMENTAL
  • Placebo ComparatorPLACEBO_COMPARATOR

التدخلات

  • دواء Placebo

    placebo comparator

  • دواء iloperidone

    iloperidone

مقاييس النتائج

  1. مقياس النتيجة الأولي

    Change from baseline to treatment week 4 in SiSBP

    الإطار الزمني screening to treatment week 4

التواريخ

التواريخ
تاريخ البدء15 سبتمبر 2025 (فعلي)
الإتمام الأولي1 أكتوبر 2026 (تقديري)
الإتمام1 نوفمبر 2026 (تقديري)
أول نشر29 يوليو 2025 (فعلي)
آخر تحديث27 فبراير 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةيناير 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

18 موقعاً قيد التجنيد

United States

United States
المنشأةالمدينةالولاية أو المنطقةالحالة
Vanda Investigative SiteBurkeVirginiaقيد التجنيد
Vanda Investigative SiteCarrolltonTexasلم يبدأ التجنيد بعد
Vanda Investigative SiteCharlestonSouth Carolinaقيد التجنيد
Vanda Investigative SiteChula VistaCaliforniaقيد التجنيد
Vanda Investigative SiteCincinnatiOhioقيد التجنيد
Vanda Investigative SiteColumbusGeorgiaقيد التجنيد
Vanda Investigative SiteDoralFloridaلم يبدأ التجنيد بعد
Vanda Investigative SiteDublinCaliforniaقيد التجنيد
Vanda Investigative SiteEl DoradoKansasقيد التجنيد
Vanda Investigative SiteFort MyersFloridaقيد التجنيد
Vanda Investigative SiteHazelwoodMissouriقيد التجنيد
Vanda Investigative SiteKinstonNorth Carolinaقيد التجنيد
Vanda Investigative SiteLas VegasNevadaلم يبدأ التجنيد بعد
Vanda Investigative SiteLexingtonKentuckyقيد التجنيد
Vanda Investigative SiteMount KiscoNew Yorkلم يبدأ التجنيد بعد
Vanda Investigative SiteNorfolkVirginiaقيد التجنيد
Vanda Investigative SiteNormanOklahomaقيد التجنيد
Vanda Investigative SiteOak BrookIllinoisقيد التجنيد
Vanda Investigative SiteOklahoma CityOklahomaلم يبدأ التجنيد بعد
Vanda Investigative SitePhoenixArizonaلم يبدأ التجنيد بعد
Vanda Investigative SiteRochesterNew Yorkلم يبدأ التجنيد بعد
Vanda Investigative SiteSalt Lake CityUtahلم يبدأ التجنيد بعد
Vanda Investigative SiteTempeArizonaقيد التجنيد
Vanda Investigative SiteTinley ParkIllinoisقيد التجنيد
Vanda Investigative SiteTucsonArizonaلم يبدأ التجنيد بعد
Vanda Investigative SiteValenciaCaliforniaلم يبدأ التجنيد بعد
Vanda Investigative SiteWalnut CreekCaliforniaقيد التجنيد
Vanda Investigative SiteWichitaKansasقيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

لم تُسجَّل أي تغييرات منذ أن أدرجنا هذا السجل لأول مرة.

يُسجَّل تغيير في كل مرة تحدّث فيها الجهة الراعية سجل السجل. تظهر هنا الحالة والتواريخ والتجنيد والمواقع كلما تغيّرت.