Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Benicar HCT · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg |
| 2 | ACTIVE_COMPARATOR | Benicar HCT ® Tablets 40 mg/25 mg |
| Name | Type | Description |
|---|---|---|
| Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg | DRUG | - |
| Benicar HCT ® Tablets 40 mg/25 mg | DRUG | - |
| Benicar HCT® Tablets 40 mg/25 mg | DRUG | - |
Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...
Benicar HCT is a combination tablet containing olmesartan medoxomil and hydrochlorothiazide. It is used to treat high blood pressure. The drug is being studied in healthy volunteers in Phase 1 clinical trials to assess its bioavailability and pharmacokinetics.
Benicar HCT is developed by Viatris Inc., which trades under the ticker VTRS. The company is conducting clinical trials to evaluate the drug's performance in healthy subjects.
Benicar HCT is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials have been completed, both involving healthy volunteers.
Benicar HCT has two completed Phase 1 trials: NCT01019590, a fed study, and NCT01020214, a fasting study. Both compare olmesartan medoxomil and hydrochlorothiazide tablets 40 mg/25 mg with Benicar HCT tablets of the same strength in healthy adults.
Benicar HCT combines olmesartan medoxomil, an angiotensin II receptor blocker, and hydrochlorothiazide, a diuretic. Olmesartan blocks the vasoconstrictive effects of angiotensin II, while hydrochlorothiazide increases urine output to lower blood pressure.