Iloperidone for adults with uncontrolled high blood pressure
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension
We are testing whether iloperidone can lower blood pressure in adults whose blood pressure stays high despite at least 8 weeks of one or more blood pressure medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vanda Pharmaceuticals Industry-sponsored |
| Locations | 28 sites (Phoenix, Arizona and 27 other locations) |
| Trial ID | NCT07090161 on ClinicalTrials.gov |
What this trial studies
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 study comparing iloperidone to placebo in adults with uncontrolled hypertension. Eligible participants must have a seated systolic blood pressure ≥130 mmHg despite more than 8 weeks of one or more antihypertensive therapies. Participants with confirmed severe (grade 3) hypertension, unstable cardiac disease, or renal insufficiency are excluded. The trial is sponsored by Vanda Pharmaceuticals and will run at Vanda investigative sites in Phoenix, Tempe, and Tucson, Arizona.
Who should consider this trial
Good fit: Adults with seated systolic BP ≥130 mmHg despite over 8 weeks of one or more antihypertensive drugs, who do not have severe hypertension, unstable heart disease, or significant kidney problems, and who can attend visits at the Arizona sites.
Not a fit: People with confirmed severe (grade 3) hypertension (SiSBP ≥180 mmHg or SiDBP ≥120 mmHg), unstable cardiac disease, renal insufficiency, or those whose blood pressure is already controlled are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, iloperidone could become an additional oral treatment option to help lower blood pressure in people whose hypertension is not controlled by current medications.
How similar studies have performed: Using iloperidone for blood pressure control is a novel approach and there is little prior clinical evidence supporting its use for hypertension.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Phoenix, Arizona and 27 other locations
- Vanda Investigative Site — Phoenix, Arizona, United States (Not_yet_recruiting)
- Vanda Investigative Site — Tempe, Arizona, United States (Recruiting)
- Vanda Investigative Site — Tucson, Arizona, United States (Not_yet_recruiting)
- Vanda Investigative Site — Chula Vista, California, United States (Recruiting)
- Vanda Investigative Site — Dublin, California, United States (Recruiting)
- Vanda Investigative Site — Valencia, California, United States (Not_yet_recruiting)
- Vanda Investigative Site — Walnut Creek, California, United States (Recruiting)
- Vanda Investigative Site — Doral, Florida, United States (Not_yet_recruiting)
- Vanda Investigative Site — Fort Myers, Florida, United States (Recruiting)
- Vanda Investigative Site — Columbus, Georgia, United States (Recruiting)
- Vanda Investigative Site — Oak Brook, Illinois, United States (Recruiting)
- Vanda Investigative Site — Tinley Park, Illinois, United States (Recruiting)
- Vanda Investigative Site — El Dorado, Kansas, United States (Recruiting)
- Vanda Investigative Site — Wichita, Kansas, United States (Recruiting)
- Vanda Investigative Site — Lexington, Kentucky, United States (Recruiting)
- Vanda Investigative Site — Hazelwood, Missouri, United States (Recruiting)
- Vanda Investigative Site — Las Vegas, Nevada, United States (Not_yet_recruiting)
- Vanda Investigative Site — Mount Kisco, New York, United States (Not_yet_recruiting)
- Vanda Investigative Site — Rochester, New York, United States (Not_yet_recruiting)
- Vanda Investigative Site — Kinston, North Carolina, United States (Recruiting)
- Vanda Investigative Site — Cincinnati, Ohio, United States (Recruiting)
- Vanda Investigative Site — Norman, Oklahoma, United States (Recruiting)
- Vanda Investigative Site — Oklahoma City, Oklahoma, United States (Not_yet_recruiting)
- Vanda Investigative Site — Charleston, South Carolina, United States (Recruiting)
- Vanda Investigative Site — Carrollton, Texas, United States (Not_yet_recruiting)
- Vanda Investigative Site — Salt Lake City, Utah, United States (Not_yet_recruiting)
- Vanda Investigative Site — Burke, Virginia, United States (Recruiting)
- Vanda Investigative Site — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Vanda Pharmaceuticals, Inc.
- Email: clinicaltrials@vandapharma.com
- Phone: 202-734-3400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.