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Olmesartan Medoxomil and Hydrochlorothiazide

Phase 3

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 23, 2024

Olmesartan Medoxomil and Hydrochlorothiazide development status

Highest phase Phase 3 run by Takeda (NCT01033071)
Phase scored for VTRSPhase 1
Registered trials 3 across 1 sponsor since Oct 2009

Olmesartan Medoxomil and Hydrochlorothiazide target and mechanism

Molecular targetAGTR1
Target classAntagonist
ModalitySmall molecule

Also known as Olmesartan Medoxomil

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials4
Total Enrollment144

FDA Designations

No designations recorded

Olmesartan Medoxomil and Hydrochlorothiazide clinical trials

Olmesartan Medoxomil and Hydrochlorothiazide · 4 trials · 1 indication

Phase 1 4
NCT01019590Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mgHealthy
COMPLETED36 Analytics
NCT01020214Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mgHealthy
COMPLETED36 Analytics
NCT00648219Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mgHealthy
COMPLETED36 Analytics
NCT00649623Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mgHealthy
COMPLETED36 Analytics
PHASE1COMPLETED
Fed Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Benicar HCT® Tablets 40 mg/25 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fed Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Olmesartan Medoxomil Tablets 40 mg and Benicar® Tablets 40 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
blood collections through 48 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOlmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg
2ACTIVE_COMPARATORBenicar HCT ® Tablets 40 mg/25 mg

Interventions

NameTypeDescription
Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mgDRUG -
Benicar HCT ® Tablets 40 mg/25 mgDRUG -
Benicar HCT® Tablets 40 mg/25 mgDRUG -
Olmesartan Medoxomil Tablets 40 mgDRUG40mg, single dose fed
Benicar® Tablets 40 mgDRUG40mg, single dose fed
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about Olmesartan Medoxomil and Hydrochlorothiazide

What is Olmesartan Medoxomil and Hydrochlorothiazide?

Olmesartan Medoxomil and Hydrochlorothiazide is a small molecule combination product developed by Viatris Inc. (VTRS). It combines olmesartan medoxomil, an AGTR1 antagonist, with hydrochlorothiazide. The program has been studied in Phase 1 clinical trials, all of which are completed, with a total enrollment of 144 participants across four studies.

What does Olmesartan Medoxomil and Hydrochlorothiazide target?

Olmesartan Medoxomil and Hydrochlorothiazide targets AGTR1, the angiotensin II receptor type 1. Olmesartan medoxomil acts as an antagonist at this receptor. Hydrochlorothiazide is a thiazide diuretic. The combination is designed to lower blood pressure through these complementary mechanisms.

Who makes Olmesartan Medoxomil and Hydrochlorothiazide?

Olmesartan Medoxomil and Hydrochlorothiazide is developed by Viatris Inc., which trades under the ticker VTRS. Viatris is the sponsor of the clinical program for this combination product.

What phase is Olmesartan Medoxomil and Hydrochlorothiazide in?

Olmesartan Medoxomil and Hydrochlorothiazide is in Phase 1 clinical development. All four of its Phase 1 trials are completed, and none are currently active. The program has enrolled 144 participants in total. It remains an investigational product and is not approved by the FDA for any indication.

What clinical trials is Olmesartan Medoxomil and Hydrochlorothiazide in?

Olmesartan Medoxomil and Hydrochlorothiazide has been evaluated in four completed Phase 1 trials: NCT01020214 (fasting study), NCT01019590 (fed study), NCT00649623 (fasting study of olmesartan medoxomil tablets), and NCT00648219 (fed study of olmesartan medoxomil tablets). All enrolled healthy volunteers in the United States.

Is Olmesartan Medoxomil and Hydrochlorothiazide the same as Olmesartan Medoxomil?

Olmesartan Medoxomil and Hydrochlorothiazide is a combination product that contains olmesartan medoxomil plus hydrochlorothiazide. Olmesartan Medoxomil alone is a separate product. The alternative names for this combination include Olmesartan Medoxomil and Hydrochlorothiazide Tablets 40 mg/25 mg and Olmesartan Medoxomil Tablets 40 mg.