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
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
- ClinicalTrials.govNCT07090161فتح هذا السجل في ClinicalTrials.govتمت المزامنة قبل شهرين
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.
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.
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
| الجنس | الجميع |
|---|---|
| الأعمار | 18 Years – 65 Years |
| المتطوعون الأصحّاء | لا |
الأهلية كما كُتبت في السجل
الأهلية في عبارات بسيطة
لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.
تصميم الدراسة
| نوع الدراسة | تدخّلية |
|---|---|
| المرحلة | المرحلة 2 |
| التخصيص | معشّاة |
| نموذج التدخّل | PARALLEL |
| الغرض الأساسي | TREATMENT |
| التعمية | QUADRUPLE (4) |
| التجنيد | مطلوب 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
مقياس النتيجة الأولي
Change from baseline to treatment week 4 in SiSBP
الإطار الزمني screening to treatment week 4
التواريخ
| تاريخ البدء | 15 سبتمبر 2025 (فعلي) |
|---|---|
| الإتمام الأولي | 1 أكتوبر 2026 (تقديري) |
| الإتمام | 1 نوفمبر 2026 (تقديري) |
| أول نشر | 29 يوليو 2025 (فعلي) |
| آخر تحديث | 27 فبراير 2026 |
| النتائج منشورة | غير مذكور في سجل السجل |
| آخر تأكيد للحالة | يناير 2026 |
فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.
المواقع
18 موقعاً قيد التجنيد
United States
| المنشأة | المدينة | الولاية أو المنطقة | الحالة |
|---|---|---|---|
| Vanda Investigative Site | Burke | Virginia | قيد التجنيد |
| Vanda Investigative Site | Carrollton | Texas | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Charleston | South Carolina | قيد التجنيد |
| Vanda Investigative Site | Chula Vista | California | قيد التجنيد |
| Vanda Investigative Site | Cincinnati | Ohio | قيد التجنيد |
| Vanda Investigative Site | Columbus | Georgia | قيد التجنيد |
| Vanda Investigative Site | Doral | Florida | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Dublin | California | قيد التجنيد |
| Vanda Investigative Site | El Dorado | Kansas | قيد التجنيد |
| Vanda Investigative Site | Fort Myers | Florida | قيد التجنيد |
| Vanda Investigative Site | Hazelwood | Missouri | قيد التجنيد |
| Vanda Investigative Site | Kinston | North Carolina | قيد التجنيد |
| Vanda Investigative Site | Las Vegas | Nevada | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Lexington | Kentucky | قيد التجنيد |
| Vanda Investigative Site | Mount Kisco | New York | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Norfolk | Virginia | قيد التجنيد |
| Vanda Investigative Site | Norman | Oklahoma | قيد التجنيد |
| Vanda Investigative Site | Oak Brook | Illinois | قيد التجنيد |
| Vanda Investigative Site | Oklahoma City | Oklahoma | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Phoenix | Arizona | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Rochester | New York | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Salt Lake City | Utah | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Tempe | Arizona | قيد التجنيد |
| Vanda Investigative Site | Tinley Park | Illinois | قيد التجنيد |
| Vanda Investigative Site | Tucson | Arizona | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Valencia | California | لم يبدأ التجنيد بعد |
| Vanda Investigative Site | Walnut Creek | California | قيد التجنيد |
| Vanda Investigative Site | Wichita | Kansas | قيد 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.