Safety and Efficacy of Azilsartan Medoxomil in Participants With Mild to Moderate Hypertension

This study has been completed.
Sponsor:
Information provided by:
Takeda
ClinicalTrials.gov Identifier:
NCT00362115
First received: August 7, 2006
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: Olmesartan
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 76 investigative sites in Argentina, Mexico, Peru and the United States from 16 May 2006 to 07 December 2006.

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

Reporting Groups
  Description
Azilsartan Medoxomil 5 mg QD Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 10 mg QD Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 20 mg QD Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 40 mg QD Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 80 mg QD Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Olmesartan 20 mg QD Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Placebo QD Matching placebo tablets, orally, once daily for up to 8 weeks.

Participant Flow:   Overall Study
    Azilsartan Medoxomil 5 mg QD     Azilsartan Medoxomil 10 mg QD     Azilsartan Medoxomil 20 mg QD     Azilsartan Medoxomil 40 mg QD     Azilsartan Medoxomil 80 mg QD     Olmesartan 20 mg QD     Placebo QD  
STARTED     65     65 [1]   64     63 [1]   64     64 [1]   64 [1]
COMPLETED     63     59     57     59     57     57     52  
NOT COMPLETED     2     6     7     4     7     7     12  
Adverse Event                 0                 1                 1                 1                 2                 2                 1  
Protocol Violation                 0                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 1                 0                 0                 2                 0                 1  
Withdrawal by Subject                 1                 3                 1                 0                 1                 3                 4  
Lack of Efficacy                 1                 0                 5                 2                 2                 0                 3  
Physician Decision                 0                 0                 0                 0                 0                 0                 3  
Other                 0                 1                 0                 1                 0                 1                 0  
[1] 1 participant failed to receive double-blind medication.



  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 5 mg QD Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 10 mg QD Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 20 mg QD Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 40 mg QD Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Azilsartan Medoxomil 80 mg QD Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Olmesartan 20 mg QD Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
Placebo QD Matching placebo tablets, orally, once daily for up to 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Azilsartan Medoxomil 5 mg QD     Azilsartan Medoxomil 10 mg QD     Azilsartan Medoxomil 20 mg QD     Azilsartan Medoxomil 40 mg QD     Azilsartan Medoxomil 80 mg QD     Olmesartan 20 mg QD     Placebo QD     Total  
Number of Participants  
[units: participants]
  65     63     64     62     64     63     61     442  
Age  
[units: participants]
               
<45 years     12     5     10     9     12     10     11     69  
Between 45 and 64 years     45     52     46     43     41     46     36     309  
≥65 years     8     6     8     10     11     7     14     64  
Gender  
[units: participants]
               
Female     29     32     30     33     28     34     32     218  
Male     36     31     34     29     36     29     29     224  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Sitting Clinic Diastolic Blood Pressure.   [ Time Frame: Baseline and Week 8. ]

2.  Secondary:   Change From Baseline in Sitting Clinic Systolic Blood Pressure.   [ Time Frame: Baseline and Week 8 ]

3.  Secondary:   Change From Baseline in Standing Clinic Systolic Blood Pressure.   [ Time Frame: Baseline and Week 8. ]

4.  Secondary:   Change From Baseline in Standing Clinic Diastolic Blood Pressure.   [ Time Frame: Baseline and Week 8. ]

5.  Secondary:   Change From Baseline in 24-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

6.  Secondary:   Change From Baseline in 24-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

7.  Secondary:   Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

8.  Secondary:   Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

9.  Secondary:   Change From Baseline in the 10-12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

10.  Secondary:   Change From Baseline in the 10-12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

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 8 ]

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 8. ]

13.  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 8. ]

14.  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 8. ]

15.  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 8. ]

16.  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 8. ]

17.  Secondary:   Change From Baseline in the 24-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

18.  Secondary:   Change From Baseline in the 24-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]

19.  Secondary:   Change From Baseline in the 34-36-Hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8 ]

20.  Secondary:   Change From Baseline in the 34-36-Hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 8. ]


  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


No publications provided


Responsible Party: Sr. VP, Clinical Science, Takeda Global Research & Development Center, Inc.
ClinicalTrials.gov Identifier: NCT00362115     History of Changes
Other Study ID Numbers: 01-05-TL-491-005, U1111-1113-8783
Study First Received: August 7, 2006
Results First Received: March 24, 2011
Last Updated: March 24, 2011
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Chile: Instituto de Salud Pública de Chile
Mexico: Ministry of Health