One-Year Safety and Tolerability Study of Azilsartan Medoxomil in Participants With Essential Hypertension

Phase 3

Completed

• Conditions: Hypertension
• Interventions: Drug: Azilsartan medoxomil with or without add-on chlorthalidone; Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide

• Registration Number: NCT00695955
• Lead Sponsor: Takeda

Brief Summary

This purpose of this study is to evaluate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Detailed Description

Hypertension affects approximately 50 million individuals in the United States. As the population ages, the prevalence of hypertension will continue to increase if broad and effective preventive measures are not implemented. According to the World Health Organization, hypertension is the most common attributable cause of preventable death in developed nations, as uncontrolled hypertension greatly increases the risk of cardiovascular disease, cerebrovascular disease, and renal failure. Despite the availability of antihypertensive treatments, hypertension remains inadequately controlled; only about one-third of patients continue to maintain control successfully.

Takeda Global Research and Development is developing TAK-491 (azilsartan medoxomil) for the treatment of essential hypertension. This study is being conducted to demonstrate the long-term safety and tolerability of azilsartan medoxomil in individuals with essential hypertension.

Study participation is anticipated to be approximately 1 year and 1.5 months, and participants will be required to return to the clinic for 10 study visits.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-10
• Study First Posted: 2008-06-12
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2011-03
• Results First Submitted: 2011-03-24
• Results First Submitted QC: 2011-03-24
• Last Update Submitted: 2011-03-24
• Results First Posted: 2011-04-19
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 669

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Azilsartan Medoxomil	Azilsartan medoxomil with or without add-on chlorthalidone	-
Azilsartan Medoxomil	Azilsartan medoxomil with or without add-on hydrochlorothiazide	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.	56 weeks.	Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.
Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.	56 weeks.	Treatment-emergent adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 14 days after the last dose of study drug, or if a serious adverse event, within 30 days after the last dose of study drug.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2	52 weeks	The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.	52 weeks.	The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.	52 weeks.	The change between sitting clinic diastolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.
Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.	52 weeks	The change between sitting clinic systolic blood pressure measured at each week assessed relative to the baseline measurement. Mean calculated by using the average (arithmetic mean) of 3 measurements performed at each visit.