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Azilsartan medoxomil- chlorthalidone

Phase 3

Essential Hypertension | Small molecule | Cardiovascular |Takeda Pharmaceutical Company Limited|Last Updated: Apr 23, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment507

FDA Designations

No designations recorded

Clinical trial landscape

Azilsartan medoxomil- chlorthalidone · 1 trial · 1 indication

Phase 3 1
NCT01456169A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil AloneEssential Hypertension
COMPLETED507 Analytics
PHASE3COMPLETED
A Study to Evaluate the Effectiveness and Safety of a Fixed Dose Combination of Azilsartan Medoxomil and Chlorthalidone in Patients With High Blood Pressure Who do Not Achieve Target Blood Pressure Following Treatment With Azilsartan Medoxomil Alone
Essential Hypertension
NCT01456169507
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Study Endpoints

Primary Endpoints

Change From Baseline to Week 8 in Trough, Sitting, Clinic Systolic Blood Pressure
Baseline (of the double-blind treatment period) and Week 8

The change between trough systolic blood pressure measured at final visit or Week 8 relative to baseline. Systolic blood pressure is the arithmetic mean of the 3 trough sitting systolic blood pressure measurements.

Secondary Endpoints

Change From Baseline to Week 8 in Trough, Sitting, Clinic Diastolic Blood Pressure
Baseline and Week 8
Change From Baseline to Week 8 in Trough Systolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Baseline and Week 8, 22-24 hours after dosing
Change From Baseline to Week 8 in Trough Diastolic Blood Pressure as Measured by Ambulatory Blood Pressure Monitoring
Baseline and Week 8, 22-24 hours after dosing
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Azilsartan medoxomil 40 mgACTIVE_COMPARATORAzilsartan medoxomil 40 mg and placebo to chlorthalidone combination tablets, orally, once daily for up to 8 weeks.
Azilsartan medoxomil + chlorthalidone 40/12.5 mgEXPERIMENTALAzilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
Azilsartan medoxomil + chlorthalidone 40/25 mgEXPERIMENTALAzilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.

Interventions

NameTypeDescription
Azilsartan medoxomil/placeboDRUGAzilsartan medoxomil and placebo to chlorthalidone combination tablets
Azilsartan medoxomil - chlorthalidoneDRUGAzilsartan medoxomil and chlorthalidone fixed dose combination tablets
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites108

Inclusion Criteria: At Screening 1. The participant has grade 2-3 essential hypertension which is not adequately controlled, as defined by mean, trough, sitting, clinic systolic blood pressure (SBP): * ≥160 to ≤180 mm Hg in participants who have not received any antihypertensive medication in ...

Countries:BulgariaEstoniaFranceGermanyHungaryItalyLithuaniaNetherlandsPolandSerbiaSlovakiaSpainSwedenUnited Kingdom
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Frequently asked questions about Azilsartan medoxomil- chlorthalidone

What is Azilsartan medoxomil-chlorthalidone used for?

Azilsartan medoxomil-chlorthalidone is used for essential hypertension, or high blood pressure. It is a fixed-dose combination being developed as a small molecule therapy for patients who do not achieve target blood pressure following treatment with azilsartan medoxomil alone. The drug is currently in Phase 3 clinical development.

Who makes Azilsartan medoxomil-chlorthalidone?

Azilsartan medoxomil-chlorthalidone is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the effectiveness and safety of this fixed-dose combination for the treatment of essential hypertension.

What phase is Azilsartan medoxomil-chlorthalidone in?

Azilsartan medoxomil-chlorthalidone is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 3 trial has been completed, involving 507 participants with essential hypertension.

What clinical trials is Azilsartan medoxomil-chlorthalidone in?

Azilsartan medoxomil-chlorthalidone has one completed Phase 3 trial, registered as NCT01456169. This randomized, double-blind, active-controlled study evaluated the effectiveness and safety of the fixed-dose combination in patients with high blood pressure who did not achieve target blood pressure with azilsartan medoxomil alone. The trial enrolled 507 participants across multiple European countries.

Is Azilsartan medoxomil-chlorthalidone the same as azilsartan medoxomil?

Azilsartan medoxomil-chlorthalidone is a fixed-dose combination that includes azilsartan medoxomil plus chlorthalidone. It is not the same as azilsartan medoxomil alone. The combination is being studied for patients who do not achieve target blood pressure with azilsartan medoxomil monotherapy.