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 Global Research & Development Center, Inc.

ClinicalTrials.gov Identifier:

NCT00696436

First received: June 10, 2008

Last updated: March 24, 2011

Last verified: March 2011

History of Changes

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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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

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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. ]

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2. Secondary:

Change From Baseline in Mean Trough Clinic Sitting Systolic Blood Pressure. [ Time Frame: Baseline and Week 6. ]

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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. ]

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4. Secondary:

Change From Baseline in Mean Trough Clinic Sitting Diastolic Blood Pressure [ Time Frame: Baseline and Week 6. ]

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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. ]

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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. ]

Show Outcome Measure 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. ]

Show Outcome Measure 7

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. ]

Show Outcome Measure 8

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. ]

Show Outcome Measure 9

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. ]

Show Outcome Measure 10

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. ]

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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. ]

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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. ]

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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. ]

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15. Secondary:

Percentage of Participants Who Achieve Both a Clinic Diastolic and Systolic Blood Pressure Response [ Time Frame: Baseline and Week 6. ]

Show Outcome Measure 15

Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.

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.

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:

White WB, Weber MA, Sica D, Bakris GL, Perez A, Cao C, Kupfer S. Effects of the angiotensin receptor blocker azilsartan medoxomil versus olmesartan and valsartan on ambulatory and clinic blood pressure in patients with stages 1 and 2 hypertension. Hypertension. 2011 Mar;57(3):413-20. Epub 2011 Jan 31.

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

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