NCT07090161

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2 hypertension

Timeline
6mo left

Started Sep 2025

Geographic Reach
1 country

28 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress57%
Sep 2025Nov 2026

First Submitted

Initial submission to the registry

July 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 27, 2026

Status Verified

January 1, 2026

Enrollment Period

1 year

First QC Date

July 22, 2025

Last Update Submit

February 25, 2026

Conditions

HypertensionUncontrolled Hypertension

Keywords

iloperidonehypertensionuncontrolled hypertension

Outcome Measures

Primary Outcomes (1)

  • Change from baseline to treatment week 4 in SiSBP

    screening to treatment week 4

Study Arms (2)

Experimental/Iloperidone

EXPERIMENTAL
Drug: iloperidone

Placebo Comparator

PLACEBO COMPARATOR
Drug: Placebo

Interventions

iloperidoneDRUG

iloperidone

Also known as: Fanapt
Experimental/Iloperidone
PlaceboDRUG

placebo comparator

Placebo Comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • SiSBP \>/= 130 mmHg despite \>8 weeks treatment w/ 1 or more antihypertensive therapies

You may not qualify if:

  • Confirmed Grade 3/severe hypertension (SiSBP \>/= 180 mmHg, SiDBP \>/= 120 mmHg), unstable cardiac disease, renal insufficiency

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Vanda Investigative Site

Phoenix, Arizona, 85053, United States

NOT YET RECRUITING

Vanda Investigative Site

Tempe, Arizona, 85281, United States

RECRUITING

Vanda Investigative Site

Tucson, Arizona, 85715, United States

NOT YET RECRUITING

Vanda Investigative Site

Chula Vista, California, 91910, United States

RECRUITING

Vanda Investigative Site

Dublin, California, 94568, United States

RECRUITING

Vanda Investigative Site

Valencia, California, 91355, United States

NOT YET RECRUITING

Vanda Investigative Site

Walnut Creek, California, 94596, United States

RECRUITING

Vanda Investigative Site

Doral, Florida, 33172, United States

NOT YET RECRUITING

Vanda Investigative Site

Fort Myers, Florida, 33912, United States

RECRUITING

Vanda Investigative Site

Columbus, Georgia, 31904, United States

RECRUITING

Vanda Investigative Site

Oak Brook, Illinois, 60523, United States

RECRUITING

Vanda Investigative Site

Tinley Park, Illinois, 60477, United States

RECRUITING

Vanda Investigative Site

El Dorado, Kansas, 67042, United States

RECRUITING

Vanda Investigative Site

Wichita, Kansas, 67226, United States

RECRUITING

Vanda Investigative Site

Lexington, Kentucky, 40509, United States

RECRUITING

Vanda Investigative Site

Hazelwood, Missouri, 63042, United States

RECRUITING

Vanda Investigative Site

Las Vegas, Nevada, 89119, United States

NOT YET RECRUITING

Vanda Investigative Site

Mount Kisco, New York, 10549, United States

NOT YET RECRUITING

Vanda Investigative Site

Rochester, New York, 14609, United States

NOT YET RECRUITING

Vanda Investigative Site

Kinston, North Carolina, 28501, United States

RECRUITING

Vanda Investigative Site

Cincinnati, Ohio, 45212, United States

RECRUITING

Vanda Investigative Site

Norman, Oklahoma, 73069, United States

RECRUITING

Vanda Investigative Site

Oklahoma City, Oklahoma, 73112, United States

NOT YET RECRUITING

Vanda Investigative Site

Charleston, South Carolina, 29414, United States

RECRUITING

Vanda Investigative Site

Carrollton, Texas, 75006, United States

NOT YET RECRUITING

Vanda Investigative Site

Salt Lake City, Utah, 84124, United States

NOT YET RECRUITING

Vanda Investigative Site

Burke, Virginia, 22015, United States

RECRUITING

Vanda Investigative Site

Norfolk, Virginia, 23502, United States

RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

iloperidone

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Vanda Pharmaceuticals, Inc.

CONTACT

202-734-3400clinicaltrials@vandapharma.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2025

First Posted

July 29, 2025

Study Start

September 15, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 27, 2026

Record last verified: 2026-01

Locations

US(28)