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Efficacy and Safety of Azilsartan Medoxomil in Participants With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00696241
First received: June 10, 2008
Last updated: July 27, 2011
Last verified: July 2011
Results First Received: March 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Azilsartan medoxomil and olmesartan
Drug: Olmesartan
Drug: Placebo

  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 147 investigative sites in Argentina, Mexico, Peru and the United States from 25 June 2007 to 08 October 2008.

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 one of five, once-daily (QD) treatment groups.

Reporting Groups
  Description
Azilsartan Medoxomil 20 mg QD Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 40 mg QD Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg QD Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg QD Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo QD Placebo-matching tablets, orally, once daily for up to 6 weeks.

Participant Flow:   Overall Study
    Azilsartan Medoxomil 20 mg QD   Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Olmesartan 40 mg QD   Placebo QD
STARTED   283   283   285   282   142 
COMPLETED   259   261   261   268   130 
NOT COMPLETED   24   22   24   14   12 
Adverse Event                11                3                6                4                5 
Protocol Violation                1                1                2                0                3 
Lost to Follow-up                1                4                1                2                0 
Withdrawal by Subject                4                8                6                1                0 
Lack of Efficacy                1                5                4                5                3 
Other                6                1                5                2                1 



  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.
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Reporting Groups
  Description
Azilsartan Medoxomil 20 mg QD Azilsartan medoxomil 20 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 40 mg QD Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg QD Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
Olmesartan 40 mg QD Olmesartan 40 mg, tablets, orally, once daily for up to 6 weeks.
Placebo QD Placebo-matching tablets, orally, once daily for up to 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Azilsartan Medoxomil 20 mg QD   Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Olmesartan 40 mg QD   Placebo QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 283   283   285   282   142   1275 
Age 
[Units: Participants]
           
<45 years   32   29   37   32   11   141 
Between 45 and 64 years   173   187   161   153   84   758 
≥65 years   78   67   87   97   47   376 
Gender 
[Units: Participants]
           
Female   150   141   136   142   66   635 
Male   133   142   149   140   76   640 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in the 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

2.  Secondary:   Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure   [ Time Frame: Baseline and Week 6. ]

3.  Secondary:   Change From Baseline in the 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

4.  Secondary:   Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure   [ Time Frame: Baseline and Week 6. ]

5.  Secondary:   Change From Baseline in Daytime (6am to 10 pm) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

6.  Secondary:   Change From Baseline in Daytime (6am to 10 pm) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

7.  Secondary:   Change From Baseline in the Nighttime (12 am to 6 am) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

8.  Secondary:   Change From Baseline in the Nighttime (12 am to 6 am) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

9.  Secondary:   Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring   [ Time Frame: Baseline and Week 6. ]

10.  Secondary:   Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring   [ Time Frame: Baseline and Week 6. ]

11.  Secondary:   Change From Baseline in the Trough (22-24-hr) Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

12.  Secondary:   Change From Baseline in the Trough (22-24-hr) Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

13.  Secondary:   Percentage of Participants Who Achieve a Clinic Systolic Blood Pressure Response, Defined as < 140 mm Hg and/or Reduction From Baseline ≥ 20 mm Hg   [ Time Frame: Baseline and Week 6. ]

14.  Secondary:   Percentage of Participants Who Achieve a Clinic Diastolic Blood Pressure Response, Defined as < 90 mm Hg and/or Reduction From Baseline ≥ 10 mm Hg   [ Time Frame: Baseline and Week 6. ]

15.  Secondary:   Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response   [ Time Frame: Baseline and Week 6. ]


  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
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  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


Publications of Results:

Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00696241     History of Changes
Other Study ID Numbers: 01-05-TL-491-008
U1111-1113-8905 ( Registry Identifier: WHO )
Study First Received: June 10, 2008
Results First Received: March 24, 2011
Last Updated: July 27, 2011