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Efficacy and Safety of Azilsartan Medoxomil, Once Daily (QD), Co-Administered With Amlodipine in Participants With Essential Hypertension

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00591266
First received: December 27, 2007
Last updated: July 18, 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 amlodipine
Drug: Amlodipine

  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 65 investigative sites in Argentina, Chile, Mexico, Peru and the United States from 03 October 2007 to 03 April 2009.

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

Reporting Groups
  Description
Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg QD Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.

Participant Flow:   Overall Study
    Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD   Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD   Amlodipine 5 mg QD
STARTED   189 [1]   188 [1]   189 [1] 
COMPLETED   180   177   175 
NOT COMPLETED   9   11   14 
Adverse Event                2                2                3 
Lost to Follow-up                0                1                0 
Protocol Violation                0                0                1 
Withdrawal by Subject                6                2                5 
Lack of Efficacy                0                2                0 
Other                1                4                5 
[1] Randomized only



  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 Amlodipine 5 mg QD Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Amlodipine 5 mg QD Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
Total Total of all reporting groups

Baseline Measures
   Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD   Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD   Amlodipine 5 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 189   188   189   566 
Age 
[Units: Participants]
       
<45 years   28   23   15   66 
Between 45 and 64 years   97   111   115   323 
≥65 years   64   54   59   177 
Gender 
[Units: Participants]
       
Female   99   85   95   279 
Male   90   103   94   287 


  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



Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00591266     History of Changes
Other Study ID Numbers: 01-05-TL-491-010
U1111-1113-9132 ( Registry Identifier: WHO )
Study First Received: December 27, 2007
Results First Received: March 24, 2011
Last Updated: July 18, 2011