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Efficacy and Safety Comparison of Azilsartan Medoxomil to Valsartan in Participants With Essential Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00591578
First Posted: January 11, 2008
Last Update Posted: February 2, 2012
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 (Responsible Party):
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: Valsartan

  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 103 investigative sites from 09 November 2007 to 03 September 2009 (double-blind phase) and 04 March 2009 to 13 March 2010 (open-label extension phase). A total of 984 participants were randomized into the double-blind treatment phase, of which 170 participants entered into the open-label extension phase.

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 three, once-daily (QD) treatment groups.

Reporting Groups
  Description
Azilsartan Medoxomil 40 mg QD

Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.

Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Azilsartan Medoxomil 80 mg QD

Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.

Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Valsartan 320 mg QD

Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.

Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).


Participant Flow for 2 periods

Period 1:   Double-Blind Treatment Phase
    Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Valsartan 320 mg QD
STARTED   327   329   328 [1] 
COMPLETED   249   249   244 
NOT COMPLETED   78   80   84 
Adverse Event                20                26                19 
Protocol Violation                3                2                3 
Lost to Follow-up                12                12                11 
Withdrawal by Subject                22                22                22 
Pregnancy                1                0                0 
Lack of Efficacy                16                9                25 
Other                4                9                4 
[1] Two participants randomized but not treated.

Period 2:   Open-Label Extension Phase
    Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Valsartan 320 mg QD
STARTED   55   115   0 
COMPLETED   49   105   0 
NOT COMPLETED   6   10   0 
Adverse Event                3                5                0 
Lost to Follow-up                1                4                0 
Withdrawal by Subject                1                1                0 
Other                1                0                0 



  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, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.

Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Azilsartan Medoxomil 80 mg QD

Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.

Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Valsartan 320 mg QD

Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.

Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).

Total Total of all reporting groups

Baseline Measures
   Azilsartan Medoxomil 40 mg QD   Azilsartan Medoxomil 80 mg QD   Valsartan 320 mg QD   Total 
Overall Participants Analyzed 
[Units: Participants]
 327   329   328   984 
Age, Customized 
[Units: Participants]
       
<45 years (Double Blind Phase)   43   39   31   113 
Between 45 and 64 years (Double Blind Phase)   181   208   199   588 
≥65 years (Double Blind Phase)   103   82   98   283 
<45 years (Open Label Phase)   10   8   0   18 
Between 45 and 64 years (Open Label Phase)   25   68   0   93 
≥65 years (Open Label Phase)   20   39   0   59 
Gender, Customized 
[Units: Participants]
       
Female (Double Blind Phase)   163   160   152   475 
Male (Double Blind Phase)   164   169   176   509 
Female (Open Label Phase)   34   57   0   91 
Male (Open Label Phase)   21   58   0   79 


  Outcome Measures
  Show All Outcome Measures

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

2.  Secondary:   Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure.   [ Time Frame: Baseline and Week 24. ]

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

4.  Secondary:   Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure   [ Time Frame: Baseline and Week 24. ]

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 24. ]

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 24. ]

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 24. ]

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 24. ]

9.  Secondary:   Change From Baseline in the 12-hour Mean Systolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 24. ]

10.  Secondary:   Change From Baseline in the 12-hour Mean Diastolic Blood Pressure Measured by Ambulatory Blood Pressure Monitoring.   [ Time Frame: Baseline and Week 24. ]

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 24. ]

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 24. ]

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 24. ]

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 24. ]

15.  Secondary:   Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response.   [ Time Frame: Baseline and Week 24. ]


  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
For the Non-Serious Adverse Event Table, the total number of participants affected is based on the AEs with ≥5% in each phase, calculated separately.


  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: Takeda
ClinicalTrials.gov Identifier: NCT00591578     History of Changes
Other Study ID Numbers: TAK-491_301
U1111-1113-9238 ( 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: February 2, 2012