HypertensionPhase 2NCT07090161
Evaluation of Efficacy and Safety of Iloperidone for the Treatment of Participants With Uncontrolled Hypertension
A Phase 2 study testing iloperidone in people with Hypertension and Uncontrolled Hypertension, run by Vanda Pharmaceuticals at 28 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hypertension, Uncontrolled Hypertension
- What is being tested?
- iloperidone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 28 sitesUnited States
- Study dates
- 15 Sep 2025to Nov 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SiSBP >/= 130 mmHg despite >8 weeks treatment w/ 1 or more antihypertensive therapies
Who cannot join
- Confirmed Grade 3/severe hypertension (SiSBP >/= 180 mmHg, SiDBP >/= 120 mmHg), unstable cardiac disease, renal insufficiency
Trial locations and contacts
28 sites in 1 country. Contact the study team or a site near you to ask about taking part.
28 sites in 1 country
United States28 sites, 28 recruiting
- Recruiting
Vanda Investigative Site
Burke, Virginia, 22015
- Not yet recruiting
Vanda Investigative Site
Carrollton, Texas, 75006
- Recruiting
Vanda Investigative Site
Charleston, South Carolina, 29414
- Recruiting
Vanda Investigative Site
Chula Vista, California, 91910
- Recruiting
Vanda Investigative Site
Cincinnati, Ohio, 45212
- Recruiting
Vanda Investigative Site
Columbus, Georgia, 31904
- Not yet recruiting
Vanda Investigative Site
Doral, Florida, 33172
- Recruiting
Vanda Investigative Site
Dublin, California, 94568
- Recruiting
Vanda Investigative Site
El Dorado, Kansas, 67042
- Recruiting
Vanda Investigative Site
Fort Myers, Florida, 33912
- Recruiting
Vanda Investigative Site
Hazelwood, Missouri, 63042
- Recruiting
Vanda Investigative Site
Kinston, North Carolina, 28501
- Not yet recruiting
Vanda Investigative Site
Las Vegas, Nevada, 89119
- Recruiting
Vanda Investigative Site
Lexington, Kentucky, 40509
- Not yet recruiting
Vanda Investigative Site
Mount Kisco, New York, 10549
- Recruiting
Vanda Investigative Site
Norfolk, Virginia, 23502
- Recruiting
Vanda Investigative Site
Norman, Oklahoma, 73069
- Recruiting
Vanda Investigative Site
Oak Brook, Illinois, 60523
- Not yet recruiting
Vanda Investigative Site
Oklahoma City, Oklahoma, 73112
- Not yet recruiting
Vanda Investigative Site
Phoenix, Arizona, 85053
- Not yet recruiting
Vanda Investigative Site
Rochester, New York, 14609
- Not yet recruiting
Vanda Investigative Site
Salt Lake City, Utah, 84124
- Recruiting
Vanda Investigative Site
Tempe, Arizona, 85281
- Recruiting
Vanda Investigative Site
Tinley Park, Illinois, 60477
- Not yet recruiting
Vanda Investigative Site
Tucson, Arizona, 85715
- Not yet recruiting
Vanda Investigative Site
Valencia, California, 91355
- Recruiting
Vanda Investigative Site
Walnut Creek, California, 94596
- Recruiting
Vanda Investigative Site
Wichita, Kansas, 67226
About this study
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
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension
- Conditions
- Hypertension, Uncontrolled Hypertension
- Being tested
- iloperidone, Placebo
- Keywords
- iloperidone, hypertension, uncontrolled hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloperidoneDrug
Also called Fanapt
iloperidone
PlaceboDrug
placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| Experimental/Iloperidone | Experimental | Not described Receives: Drug: iloperidone |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to treatment week 4 in SiSBP
Measured: screening to treatment week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start15 Sep 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090161
- Sponsor's protocol ID
- VP-VYV-683-2401
- Status last verified
- Jan 2026
- First submitted
- 22 Jul 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07090161
- Acronym / sponsor ID
- VP-VYV-683-2401
- Conditions
- Hypertension, Uncontrolled Hypertension
- Keywords
- iloperidone, hypertension, uncontrolled hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Iloperidone for the Treatment of Participants with Uncontrolled Hypertension
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental/Iloperidone | Experimental | Drug: iloperidone |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SiSBP >/= 130 mmHg despite >8 weeks treatment w/ 1 or more antihypertensive therapies
Key exclusion criteria (1 listed)
- Confirmed Grade 3/severe hypertension (SiSBP >/= 180 mmHg, SiDBP >/= 120 mmHg), unstable cardiac disease, renal insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iloperidoneAlso: Fanaptiloperidone | Drug | Experimental/Iloperidone |
| Placeboplacebo comparator | Drug | Placebo Comparator |
Primary outcome
Change from baseline to treatment week 4 in SiSBP
Time frame: screening to treatment week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing iloperidone in people with Hypertension and Uncontrolled Hypertension, run by Vanda Pharmaceuticals at 28 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vanda Pharmaceuticals, Inc. (202-734-3400, clinicaltrials@vandapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline to treatment week 4 in SiSBP (time frame: screening to treatment week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.