240 Participants Needed

Iloperidone for High Blood Pressure

Recruiting at 15 trial locations
AH
VP
Overseen ByVanda Pharmaceuticals, Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanda Pharmaceuticals
Must be taking: Antihypertensives
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Iloperidone, an antipsychotic medication, to determine its effectiveness for people with high blood pressure not controlled by other treatments. The study aims to assess the safety and efficacy of Iloperidone for individuals who have struggled with high blood pressure despite taking medication for more than eight weeks. Participants will receive either Iloperidone or a placebo (a pill with no active medicine) to compare results. Individuals whose blood pressure remains high despite medication may be a good fit for this trial. As a Phase 2 trial, this research focuses on measuring Iloperidone's effectiveness in an initial, smaller group of people.

Is there any evidence suggesting that Iloperidone is likely to be safe for humans?

Research has shown that iloperidone, a medication typically used for mental health issues, is being tested for its effects on high blood pressure. Earlier studies found that iloperidone can alter blood pressure, primarily lowering it during the first week of treatment, though these changes are usually short-lived.

Some individuals have experienced a drop in blood pressure upon standing, leading to dizziness. This occurred in 5% of those taking higher doses and less frequently with lower doses. Iloperidone can also cause side effects such as difficulty breathing, a rapid heartbeat, or a high fever, especially when combined with certain other medications.

Iloperidone has FDA approval for other uses, indicating that its safety profile is well understood. However, individual reactions may vary, so monitoring for any serious side effects is crucial.12345

Why do researchers think this study treatment might be promising?

Iloperidone is unique because, unlike most treatments for high blood pressure that focus on dilating blood vessels or reducing heart rate, it targets the brain's neurotransmitter systems. This drug is traditionally used for managing schizophrenia, but it's being explored for blood pressure control due to its novel mechanism of balancing neurotransmitters, which might indirectly influence blood pressure regulation. Researchers are excited about this treatment because it offers a completely different approach from current options like ACE inhibitors or beta-blockers, potentially benefiting patients who don't respond well to conventional therapies.

What evidence suggests that Iloperidone might be an effective treatment for high blood pressure?

Research has shown that iloperidone, a medication typically used for mental health issues, might help lower blood pressure. One study found that it reduced the systolic blood pressure in individuals with initially high levels. Another study with animals also demonstrated that iloperidone significantly lowered blood pressure. However, some findings suggest that while blood pressure may drop initially, this effect might not last long. This trial will evaluate iloperidone's effectiveness in lowering blood pressure compared to a placebo. Although signs indicate it could work, the long-term effects on blood pressure remain uncertain.46789

Are You a Good Fit for This Trial?

This trial is for people with high blood pressure that's still too high even after being on one or more blood pressure medications for over 8 weeks. Participants should have a systolic blood pressure (the top number) of 130 mmHg or higher.

Inclusion Criteria

My blood pressure is 130 mmHg or higher despite taking blood pressure medicine for over 8 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Iloperidone or placebo in a double-blind manner

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Iloperidone
Trial Overview The study is testing the effectiveness and safety of a drug called Iloperidone in treating uncontrolled hypertension, compared to a placebo. It's conducted across multiple centers where participants are randomly assigned to either receive Iloperidone or an inactive substance without knowing which one they're getting.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental/IloperidoneExperimental Treatment1 Intervention
Group II: Placebo ComparatorPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanda Pharmaceuticals

Lead Sponsor

Trials
68
Recruited
19,900+

Citations

ANTIHYPERTENSIVE EFFECT OF ILOPERIDONE IN ...Conclusions: Iloperidone was able to decrease SBP in participants with baseline Standing SBP > 130 mmHg, including those with comorbid hypertension. Additional ...
Antihypertensive and ocular hypotensive activity in animalsResults. Iloperidone (0.1 mg/Kg) showed significant decrease in blood pressure (38.96 ± 1.1%) in normotensive rats, while in DOCA salt induced ...
Long-term efficacy and safety of iloperidone: an update - PMCThe primary outcome measure was PANSS-T change score. Improvement from baseline was observed in patients treated with iloperidone (−12.0 points, ...
Efficacy and Safety of Iloperidone in Bipolar ManiaAt 4 weeks of treatment, patients receiving iloperidone showed significant improvement on the Young Mania Rating Scale versus those ...
Iloperidone (Fanapt®) - Texas Health and Human ServicesBlood pressure decreases were primarily observed within the first week of treatment and, in general, were not sustained. No significant changes in blood ...
Iloperidone (oral route) - Side effects & dosageCheck with your doctor right away if you have difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased ...
FANAPT (iloperidone) tablets - accessdata.fda.govUndesirable alterations in lipids have been observed in patients treated with atypical antipsychotics. Data from a placebo-controlled, 4-week, fixed-dose study, ...
Iloperidone Uses, Side Effects & WarningsIloperidone can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart ...
Iloperidone: uses, dosing, warnings, adverse events, ...Orthostatic hypotension was reported in 5% of patients receiving 20-24 mg of iloperidone daily, 3% of patients receiving 10-16 mg of iloperidone daily, and 1% ...
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