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Recruiting NCT07090161

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

Phase II Interventional Hypertension Uncontrolled Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: iloperidone, Placebo.
Who it may be relevant to
Registry conditions: Hypertension, Uncontrolled Hypertension. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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

Interventions

  • Drug iloperidone
    iloperidone
  • Drug Placebo
    placebo comparator

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 28 centers
  • Vanda Investigative Site — Phoenix
  • Vanda Investigative Site — Tempe
  • Vanda Investigative Site — Tucson
  • Vanda Investigative Site — Chula Vista
  • Vanda Investigative Site — Dublin
  • Vanda Investigative Site — Valencia
  • Vanda Investigative Site — Walnut Creek
  • Vanda Investigative Site — Doral
  • … and 20 more centers

Identifiers

NCT: NCT07090161 · VP-VYV-683-2401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗