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An Efficacy and Safety Study of Azilsartan Medoxomil Compared to Valsartan and Olmesartan in Participants With Essential Hypertension.

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00696436
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: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Azilsartan medoxomil
Drug: Valsartan
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 141 investigative sites in Guatemala, Mexico, Peru, Puerto Rico and the United States from 02 April 2008 to 19 August 2009.

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 40 mg QD

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan Medoxomil 80 mg QD

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 320 mg QD

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 40 mg QD

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Placebo QD Matching placebo, orally, once daily for up to six weeks.

Participant Flow:   Overall Study
    Azilsartan Medoxomil 40 mg QD     Azilsartan Medoxomil 80 mg QD     Valsartan 320 mg QD     Olmesartan 40 mg QD     Placebo QD  
STARTED     280 [1]   285 [2]   282 [1]   290 [1]   154 [1]
COMPLETED     257     255     254     268     141  
NOT COMPLETED     23     30     28     22     13  
Adverse Event                 7                 9                 8                 6                 4  
Protocol Violation                 3                 2                 2                 0                 1  
Lost to Follow-up                 1                 6                 2                 4                 3  
Withdrawal by Subject                 4                 11                 5                 7                 1  
Lack of Efficacy                 3                 1                 5                 2                 4  
Participant Unavailability                 2                 0                 2                 1                 0  
Administrative Error                 2                 0                 2                 0                 0  
Participant Non-compliance                 0                 0                 1                 2                 0  
Administrative Decision                 1                 0                 0                 0                 0  
Missing                 0                 1                 1                 0                 0  
[1] Randomized participants only.
[2] Randomized participants only. One participant treated but not randomized and is not included.



  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 40 mg QD

Azilsartan medoxomil 20 mg, tablets and matching placebo comparator orally once daily for two weeks.

Increased to azilsartan medoxomil 40 mg tablets and matching placebo comparator orally, once daily for up to four weeks.

Azilsartan Medoxomil 80 mg QD

Azilsartan medoxomil 40 mg, tablets and matching placebo comparator orally, once daily for two weeks.

Increased to Azilsartan medoxomil 80 mg, tablets and matching placebo comparator orally, once daily for up to four weeks.

Valsartan 320 mg QD

Valsartan 160 mg, tablets, and matching placebo comparator orally, once daily for two weeks.

Increased to Valsartan 320 mg, tablets, and matching placebo comparator, orally, once daily for up to four weeks.

Olmesartan 40 mg QD

Olmesartan 20 mg, tablets and matching placebo comparator, orally, once daily for two weeks.

Increased to Olmesartan 40 mg, tablets and matching placebo comparator, orally, once daily for up to four weeks.

Placebo QD Matching placebo, orally, once daily for up to six weeks.
Total Total of all reporting groups

Baseline Measures
    Azilsartan Medoxomil 40 mg QD     Azilsartan Medoxomil 80 mg QD     Valsartan 320 mg QD     Olmesartan 40 mg QD     Placebo QD     Total  
Number of Participants  
[units: participants]
  280     285     282     290     154     1291  
Age  
[units: participants]
           
<45 years     41     38     56     39     20     194  
Between 45 and 64 years     170     184     178     185     98     815  
≥65 years     69     63     48     66     36     282  
Gender  
[units: participants]
           
Female     133     134     130     131     64     592  
Male     147     151     152     159     90     699  



  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: NCT00696436     History of Changes
Other Study ID Numbers: 01-06-TL-491-019, U1111-1113-9161
Study First Received: June 10, 2008
Results First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration