We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Azilsartan Medoxomil in African American Participants With Essential Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591253
First Posted: January 11, 2008
Last Update Posted: April 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Takeda
Results First Submitted: March 24, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hypertension
Interventions: Drug: Azilsartan medoxomil
Drug: Placebo

  Participant Flow
  Hide Participant Flow

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 74 investigative sites in Puerto Rico and the United States from 30 October 2007 to 30 April 2009.

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

Reporting Groups
  Description
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.
Placebo QD Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.

Participant Flow:   Overall Study
    Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Placebo QD
STARTED   140 [1]   137 [1]   138 [1] 
COMPLETED   126   116   123 
NOT COMPLETED   14   21   15 
Adverse Event                3                3                1 
Protocol Violation                2                2                2 
Lost to Follow-up                2                4                0 
Withdrawal by Subject                1                7                6 
Lack of Efficacy                1                0                3 
Other                5                5                3 
[1] Randomized or Treated



  Baseline Characteristics
  Hide Baseline Characteristics

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 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.
Placebo QD Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Placebo QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 138   137   138   413 
Age 
[Units: Participants]
       
<45 years   29   37   36   102 
Between 45 and 64 years   94   86   85   265 
≥65 years   15   14   17   46 
Gender 
[Units: Participants]
       
Female   78   80   78   236 
Male   60   57   60   177 


  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-hr Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 6. ]

10.  Secondary:   Change From Baseline in the 12-hr 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
  Hide Limitations and Caveats

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
  Hide More Information

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: NCT00591253     History of Changes
Other Study ID Numbers: 01-06-TL-491-011
U1111-1113-8925 ( Registry Identifier: WHO )
First Submitted: December 27, 2007
First Posted: January 11, 2008
Results First Submitted: March 24, 2011
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011



To Top