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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Key information

Conditions

Hypertension Cardiovascular Diseases Uncontrolled Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Vanda Investigative Site, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iloperidone

Drug

iloperidone

Other names: Fanapt

Placebo

Drug

placebo comparator

Primary outcomes

Change from baseline to treatment week 4 in SiSBP

Time frame: screening to treatment week 4

Study contacts

Contact information is provided by the study sponsor or research team.

Vanda Pharmaceuticals, Inc.

CONTACT

[email protected]

202-734-3400

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: Jul 29, 2025
Registry last updated: Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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