Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone in Participants With Moderate to Severe Hypertension
Recruiting in Palo Alto (17 mi)
+52 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Takeda
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
The purpose of this study is to compare the antihypertensive effect of chlorthalidone vs hydrochlorothiazide when each is used with azilsartan medoxomil, once daily (QD), in participants with moderate to severe essential hypertension.
Research Team
EM
Executive Medical Director
Principal Investigator
Takeda
Eligibility Criteria
Inclusion Criteria
Is treated with antihypertensive therapy and has a post-washout mean sitting clinic SBP greater than or equal to 160 and less than or equal to 190 mm Hg on Day -1; or the participant has not received antihypertensive treatment within 28 days prior to Screening and has a mean sitting clinic SBP greater than or equal to 160 and less than or equal to 190 mm Hg at the Screening Visit and on Day -1.
Females of childbearing potential who are sexually active agree to routinely use adequate contraception from Screening through 30 days after the last administered study drug dose.
Has clinical laboratory test results (clinical chemistry, hematology, and complete urinalysis) within the reference range for the testing laboratory or the investigator does not consider the results to be clinically significant.
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Treatment Details
Interventions
- Azilsartan medoxomil (Angiotensin II Receptor Blocker)
- Chlorthalidone (Thiazide Diuretic)
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QDExperimental Treatment1 Intervention
Group II: Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QDExperimental Treatment1 Intervention
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Who Is Running the Clinical Trial?
Takeda
Lead Sponsor
Trials
1,255
Recruited
4,219,000+
Dr. Naoyoshi Hirota
Takeda
Chief Medical Officer since 2020
MD from University of Tokyo
Christophe Weber
Takeda
Chief Executive Officer since 2015
PhD in Molecular Biology from Université de Montpellier