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

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00695955
First received: June 10, 2008
Last updated: March 24, 2011
Last verified: March 2011
Results First Received: March 24, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Azilsartan medoxomil with or without add-on chlorthalidone
Drug: Azilsartan medoxomil with or without add-on hydrochlorothiazide

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants enrolled at 39 investigative sites in Chile, Mexico and the United States from 22 June 2007 to 30 April 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants with essential hypertension were enrolled in a once-daily (QD) treatment group.

Reporting Groups
  Description
Azilsartan Medoxomil

Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.

Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.


Participant Flow for 2 periods

Period 1:   Cohort 1
    Azilsartan Medoxomil
STARTED   362 
COMPLETED   260 
NOT COMPLETED   102 
Adverse Event                26 
Protocol Violation                2 
Lost to Follow-up                30 
Withdrawal by Subject                25 
Lack of Efficacy                3 
Other                16 

Period 2:   Cohort 2
    Azilsartan Medoxomil
STARTED   307 
COMPLETED   203 
NOT COMPLETED   104 
Adverse Event                24 
Protocol Violation                5 
Lost to Follow-up                38 
Withdrawal by Subject                28 
Lack of Efficacy                4 
Other                5 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azilsartan Medoxomil

Cohort 1: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with chlorthalidone 25 mg, once-daily, if target blood pressure not achieved.

Cohort 2: Azilsartan medoxomil 40 mg, tablets, orally, once daily for four weeks; increased to azilsartan medoxomil 80 mg, tablets, orally, once daily for remainder of 56-week treatment period, if tolerated. Additional antihypertensive medications added, beginning with hydrochlorothiazide 12.5 to 25 mg, once-daily, if target blood pressure not achieved.


Baseline Measures
   Azilsartan Medoxomil 
Overall Participants Analyzed 
[Units: Participants]
 669 
Age, Customized 
[Units: Participants]
 
<45 years (Cohort 1)   81 
Between 45 and 64 years (Cohort 1)   233 
≥65 years (Cohort 1)   48 
<45 years (Cohort 2)   90 
Between 45 and 64 years (Cohort 2)   193 
≥65 years (Cohort 2)   24 
Gender, Customized 
[Units: Participants]
 
Female (Cohort 1)   173 
Male (Cohort 1)   189 
Female (Cohort 2)   144 
Male (Cohort 2)   163 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 1.   [ Time Frame: 56 weeks. ]

2.  Primary:   Number of Participants Reporting One or More Treatment-emergent Adverse Events From Day 1 Through End of the Study - Cohort 2.   [ Time Frame: 56 weeks. ]

3.  Secondary:   Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 1.   [ Time Frame: 52 weeks ]

4.  Secondary:   Change From Baseline in Sitting Clinic Systolic Blood Pressure - Cohort 2   [ Time Frame: 52 weeks ]

5.  Secondary:   Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 1.   [ Time Frame: 52 weeks. ]

6.  Secondary:   Change From Baseline in Sitting Clinic Diastolic Blood Pressure - Cohort 2.   [ Time Frame: 52 weeks. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sr. VP, Clinical Science
Organization: Takeda Global Research and Development Center, Inc.
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00695955     History of Changes
Other Study ID Numbers: 01-05-TL-491-006
U1111-1113-8874 ( Registry Identifier: WHO )
Study First Received: June 10, 2008
Results First Received: March 24, 2011
Last Updated: March 24, 2011