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Angiotensin II Receptor Blocker

Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD for High Blood Pressure

Phase 3
Waitlist Available
Research Sponsored by Takeda
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and week 6.
Awards & highlights
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions
No Placebo-Only Group

Summary

The purpose of this study is to evaluate the efficacy and safety of azilsartan medoxomil, once daily (QD), co-administered with chlorthalidone in treating individuals with essential hypertension, compared to treatment with chlorthalidone alone.

Eligible Conditions
  • High Blood Pressure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and week 6.
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and week 6. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Secondary study objectives
Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.
Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure.
+11 more

Side effects data

From 2009 Phase 3 trial • 551 Patients • NCT00591773
9%
Dizziness
7%
Plasminogen activator inhibitor increased
4%
Headache
1%
Heart rate decreased
1%
Hypertensive crisis
1%
Atrioventricular block complete
1%
Chest discomfort
1%
Syncope
1%
Hypokalaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD
Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD
Chlorthalidone 25 mg QD

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QDExperimental Treatment1 Intervention
Group II: Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QDExperimental Treatment1 Intervention
Group III: Chlorthalidone 25 mg QDActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Chlorthalidone
FDA approved

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor
1,238 Previous Clinical Trials
4,148,647 Total Patients Enrolled
Executive Medical Director Clinical ScienceStudy DirectorTakeda
7 Previous Clinical Trials
7,721 Total Patients Enrolled
~30 spots leftby Nov 2025
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