Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension

NCT07090161 — Phase 2, Recruiting, 240 participants, Vanda Pharmaceuticals
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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

RegistryNCT07090161
StatusRecruiting
PhasePhase 2
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment240 (Estimated)
SponsorVanda Pharmaceuticals (Industry)
ConditionsHypertension, Uncontrolled Hypertension
Interventionsiloperidone, Placebo (Drug)
Datesstart 2025-09-15, primary completion 2026-10-01 (estimated), completion 2026-11-01 (estimated), first posted 2025-07-29, last updated 2026-02-27
Locations28 sites in United States

Related Papers Related Patents Related Grants Related Experts
All trials for Hypertension All trials for Uncontrolled Hypertension All trials of iloperidone All trials of Placebo

-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

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+Arms and interventions

ArmTypeInterventionsDescription
Experimental/IloperidoneExperimentalDrug: iloperidone
Placebo ComparatorPlacebo comparatorDrug: Placebo
  • iloperidone (Drug), also known as Fanapt: iloperidone
  • Placebo (Drug): placebo comparator

+Outcome measures

Primary outcomes

  • Change from baseline to treatment week 4 in SiSBP [screening to treatment week 4]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (28)

FacilityCityCountryStatus
Vanda Investigative SitePhoenix, ArizonaUnited StatesNot yet recruiting
Vanda Investigative SiteTempe, ArizonaUnited StatesRecruiting
Vanda Investigative SiteTucson, ArizonaUnited StatesNot yet recruiting
Vanda Investigative SiteChula Vista, CaliforniaUnited StatesRecruiting
Vanda Investigative SiteDublin, CaliforniaUnited StatesRecruiting
Vanda Investigative SiteValencia, CaliforniaUnited StatesNot yet recruiting
Vanda Investigative SiteWalnut Creek, CaliforniaUnited StatesRecruiting
Vanda Investigative SiteDoral, FloridaUnited StatesNot yet recruiting
Vanda Investigative SiteFort Myers, FloridaUnited StatesRecruiting
Vanda Investigative SiteColumbus, GeorgiaUnited StatesRecruiting
Vanda Investigative SiteOak Brook, IllinoisUnited StatesRecruiting
Vanda Investigative SiteTinley Park, IllinoisUnited StatesRecruiting
Vanda Investigative SiteEl Dorado, KansasUnited StatesRecruiting
Vanda Investigative SiteWichita, KansasUnited StatesRecruiting
Vanda Investigative SiteLexington, KentuckyUnited StatesRecruiting
Vanda Investigative SiteHazelwood, MissouriUnited StatesRecruiting
Vanda Investigative SiteLas Vegas, NevadaUnited StatesNot yet recruiting
Vanda Investigative SiteMount Kisco, New YorkUnited StatesNot yet recruiting
Vanda Investigative SiteRochester, New YorkUnited StatesNot yet recruiting
Vanda Investigative SiteKinston, North CarolinaUnited StatesRecruiting
Vanda Investigative SiteCincinnati, OhioUnited StatesRecruiting
Vanda Investigative SiteNorman, OklahomaUnited StatesRecruiting
Vanda Investigative SiteOklahoma City, OklahomaUnited StatesNot yet recruiting
Vanda Investigative SiteCharleston, South CarolinaUnited StatesRecruiting
Vanda Investigative SiteCarrollton, TexasUnited StatesNot yet recruiting
Vanda Investigative SiteSalt Lake City, UtahUnited StatesNot yet recruiting
Vanda Investigative SiteBurke, VirginiaUnited StatesRecruiting
Vanda Investigative SiteNorfolk, VirginiaUnited StatesRecruiting