An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Patients With Type II Diabetes - Study Results

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: olmesartan medoxomil Drug: Olmesartan medoxomil plus Hydrochlorothiazide

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited at 24 US sites over 10 months from November 2006 to August 2007 from each physician’s clientele base. Approximately 200 eligible subjects, men and women at least 18 years of age with stage I/II hypertension and stable type 2 diabetes mellitus, were to be enrolled on active treatment.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
192 participants started this single arm titration study. Participants remained in their group or were titrated at 3-week intervals depending on achievement their blood pressure goals.

Reporting Groups

	Description
Active Treatment Period	All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.

Description

Active Treatment Period

All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.

Participant Flow for 4 periods

Period 1: Olmesartan Medoxomil (Olm) 20 mg

	Active Treatment Period
STARTED	192
COMPLETED	186
NOT COMPLETED	6
Adverse Event	1
Physician Decision	1
Protocol Violation	3
Withdrawal by Subject	1
non-compliant	0
not specified	0
Lost to Follow-up	0

Period 2: Olm 40 mg

	Active Treatment Period
STARTED	182 ^[1]
COMPLETED	177
NOT COMPLETED	5
Adverse Event	2
Protocol Violation	1
Withdrawal by Subject	1
Unknown	1

[1]	186 -4 met their blood pressure goal (remained on olmesartan 20 mg) = 182

Period 3: Olm 40 mg + Hydrochlorothiazide 12.5 mg

	Active Treatment Period
STARTED	173 ^[1]
COMPLETED	168
NOT COMPLETED	5
Adverse Event	2
Protocol Violation	1
Withdrawal by Subject	1
Unknown	1

[1]	177 -4 met their blood pressure goal (remained on olmesartan 40 mg)= 173

Period 4: Olm 40 mg + Hydrochlorothiazide 25 mg

	Active Treatment Period
STARTED	144 ^[1]
COMPLETED	142
NOT COMPLETED	2
Withdrawal by Subject	1
Lost to Follow-up	1

[1]	168 -24 met their blood pressure goal (remained on olmesartan 40 mg/hydrochlorothiazide 12.5mg)= 144

Baseline Characteristics

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Reporting Groups

	Description
Active Treatmant Arm	All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.

Description

Active Treatmant Arm

All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.

Baseline Measures

	Active Treatmant Arm
Number of Participants [units: participants]	192
Age [units: years] Mean ± Standard Deviation	58.1 ± 10.3
Gender [units: participants]
Female	85
Male	107
Race/Ethnicity, Customized [units: Participants]
Black/African American	43
Asian	3
White	145
Native Hawaiian/Pacific Islander	1
Region of Enrollment [units: participants]
United States	192
Diastolic BP [units: mm Hg] Mean ± Standard Deviation	90.0 ± 10.0
Heart rate [units: beats/min] Mean ± Standard Deviation	76.4 ± 10.4
Systolic BP [units: mm Hg] Mean ± Standard Deviation	158.1 ± 12.6

Outcome Measures

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1. Primary:

Change From Baseline to Week 12 in Systolic BP (SBP) as Measured by 24-hour ABPM. [ Time Frame: baseline and 12 weeks ]

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2. Secondary:

Change From Baseline to Week 12 in Mean Daytime and Nighttime Ambulatory Blood Pressure Measurement (Systolic). [ Time Frame: baseline and 12 weeks ]

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3. Secondary:

Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 2 Hours of the Last (Week 12) 24-hour Dosing Period. [ Time Frame: baseline and 12 weeks ]

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4. Secondary:

Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 4 Hours of the Last (Week 12 ) 24-hour Dosing Period. [ Time Frame: baseline and 12 weeks ]

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5. Secondary:

Change From Baseline to Week 12 in Ambulatory BP Measurement (Systolic)During the Last 6 Hours of the Last (Week 12 ) 24-hour Dosing Period. [ Time Frame: baseline and 12 weeks ]

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6. Secondary:

Change From Baseline to Week 12 in Mean 24-hour Ambulatory BP (Diastolic) [ Time Frame: baseline and 12 weeks ]

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7. Secondary:

Change in Daytime and Nighttime Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 [ Time Frame: baseline and 12 weeks ]

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8. Secondary:

Change in Ambulatory Blood Pressure (Diastolic) From Baseline to Week 12 During the Last 2 Hours of the Last (Week 12 ) 24-hour Dosing Period. [ Time Frame: baseline and 12 Weeks ]

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9. Secondary:

Change in Ambulatory BP (Diastolic) From Baseline to Week 12 During the Last (Week 12 ) 4 and 6 Hours of the Last 24-hour Dosing Period. [ Time Frame: baseline and 12 weeks ]

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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: If identified by Daiichi Sankyo Inc., any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving Daiichi Sankyo, Inc. any right of editorial control over any publication prepared by the study site.

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: John J. Raia, R.Ph, Pharm. D.
Organization: Daiichi Sankyo
phone: 1-877-437-7763
e-mail: druginfo@dsus.com

No publications provided by Daiichi Sankyo Inc.

Publications automatically indexed to this study:

Kereiakes DJ, Neutel JM. Seated cuff blood pressure-lowering efficacy of an olmesartan medoxomil-based treatment regimen in patients with type 2 diabetes mellitus. Drugs R D. 2011 Sep 1;11(3):251-7.

Neutel JM, Kereiakes DJ; BENIFICIARY Investigators. An olmesartan medoxomil-based treatment algorithm is effective in achieving 24-hour BP control in patients with type 2 diabetes mellitus, regardless of age, race, sex, or severity of hypertension: subgroup analysis of the BENIFICIARY study. Am J Cardiovasc Drugs. 2010;10(5):289-303.

Responsible Party:	William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00403481 History of Changes
Other Study ID Numbers:	866-449
Study First Received:	November 22, 2006
Results First Received:	November 21, 2008
Last Updated:	November 9, 2009
Health Authority:	United States: Food and Drug Administration