An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00412932

Recruitment Status : Completed

First Posted : December 19, 2006

Results First Posted : September 11, 2009

Last Update Posted : September 22, 2009

Sponsor:

Information provided by:

Daiichi Sankyo, Inc.

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition:	Hypertension
Interventions:	Drug: Olmesartan medoxomil Drug: Olmesartan medoxomil/hydrochlorothiazide

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 were recruited at 37 US sites (private medical practices and small clinics) over 13 months (Nov 29,06 to Dec 28,07) from each physician’s clientele base. Approximately 200 eligible participants, men and women at least 65 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After 3-4 weeks of placebo, patients with a systolic pressure (SBP) ≥150 ≤199mmHg and diastolic pressure (DBP) ≤109 mmHg at the last 2 visits, and 8-hr daytime SBP >140 and ≤199 mmHg and DBP ≤109 mmHg by ambulatory blood pressure monitoring were entered.All started with Olmesartan 20 mg and were titrated if their blood pressure was not controlled

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 40 mg + 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 40 mg + HCTZ 25 mg if their blood pressure was not controlled.

Participant Flow for 4 periods

Period 1: Olmesartan (Olm) 20 mg

	Active Treatment Period
STARTED	178
COMPLETED	171
NOT COMPLETED	7
Adverse Event	1
Lack of Efficacy	2
Protocol Violation	1
Withdrawal by Subject	2
Other	1

Period 2: Olmesartan 40 mg

	Active Treatment Period
STARTED	169 ^[1]
COMPLETED	161
NOT COMPLETED	8
Adverse Event	4
Lack of Efficacy	3
Withdrawal by Subject	1

^[1]	171 -1 met blood pressure goal (stayed on olmesartan 20) -1 who erroneously skipped this step = 169.

Period 3: Olm+Hydrochlorothiazide 12.5 mg

	Active Treatment Period
STARTED	159 ^[1]
COMPLETED	153
NOT COMPLETED	6
Adverse Event	3
Withdrawal by Subject	3

^[1]	161 -2 met blood pressure goal (stayed on olmesartan 40) = 159

Period 4: Olm+ Hydrochlorothiazide 25 mg

	Active Treatment Period
STARTED	125 ^[1]
COMPLETED	123
NOT COMPLETED	2
Adverse Event	1
Lost to Follow-up	1

^[1]	153 -28 met their blood pressure goal (stayed on olmesartan 40/hydrochlorothiazide 12.5) = 125

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.
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Reporting Groups

	Description
Active Treatment Period	All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg 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 40 mg + HCTZ 25 mg if their blood pressure was not controlled.

Description

Active Treatment Period

All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg 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 40 mg + HCTZ 25 mg if their blood pressure was not controlled.

Baseline Measures

Active Treatment Period

Overall Participants Analyzed
[Units: Participants]

178

Age
[Units: Years]
Mean (Standard Deviation)

72.0 (5.3)

Gender
[Units: Participants]

Female

Male

Region of Enrollment
[Units: Participants]

United States

178

Baseline stage of hypertension ^[1]
[Units: Participants]

Stage 1 hypertension

Stage 2 hypertension

116

^[1]	Stage I hypertension is defined as systolic blood pressure (SBP) of 140 – 159 mmHg and diastolic blood pressure (DBP) of 90 – 99 mmHg; Stage II is defined as SBP ≥ 160 mmHg or DBP ≥ 100 mm Hg.

Baseline 24-hour ambulatory diastolic blood pressure
[Units: Mm Hg]
Mean (Standard Deviation)

80.7 (8.5)

Baseline 24-hour ambulatory systolic blood pressure
[Units: Mm Hg]
Mean (Standard Deviation)

149.1 (11.2)

Baseline diastolic blood pressure
[Units: Mm Hg]
Mean (Standard Deviation)

87.7 (9.6)

Baseline heart rate
[Units: Beats/minute]
Mean (Standard Deviation)

71.5 (11.4)

Baseline systolic blood pressure
[Units: Mm Hg]
Mean (Standard Deviation)

165.5 (11.9)

Outcome Measures

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1. Primary:

Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]

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2. Secondary:

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ]

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3. Secondary:

Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]

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4. Secondary:

Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]

Show Outcome Measure 4

5. Secondary:

Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment [ Time Frame: baseline to 12 weeks ]

Show Outcome Measure 5

6. Secondary:

Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ]

Show Outcome Measure 6

7. Secondary:

Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment. [ Time Frame: baseline to 12 weeks ]

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Serious Adverse Events

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Other Adverse Events

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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:

	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. (DSI), any of DSI's confidential information as defined herein shall be deleted. Nothing in this Publication section shall be taken as giving DSI the right of editorial control over any publication prepared by the study site."

Results Point of Contact:

Name/Title: John Raia
Organization: Daiichi Sankyo
phone: 973-630-2683
e-mail: jraia@dsus.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Germino FW, Neutel JM, Dubiel R, Maa JF, Chavanu KJ. Efficacy of olmesartan medoxomil and hydrochlorothiazide fixed-dose combination therapy in patients aged 65 years and older with stage 1 and 2 hypertension or isolated systolic hypertension. Am J Cardiovasc Drugs. 2012 Oct 1;12(5):325-33. doi: 10.2165/11635000-000000000-00000.

Neutel J, Kereiakes DJ, Stoakes KA, Maa JF, Shojaee A, Waverczak WF. Blood pressure-lowering efficacy of an olmesartan medoxomil/hydrochlorothiazide-based treatment algorithm in elderly patients (age ≥65 years) stratified by age, sex and race: subgroup analysis of a 12-week, open-label, single-arm, dose-titration study. Drugs Aging. 2011 Jun 1;28(6):477-90. doi: 10.2165/11589460-000000000-00000.

Responsible Party:	William Waverczak, Daiichi Sankyo
ClinicalTrials.gov Identifier:	NCT00412932 History of Changes
Other Study ID Numbers:	866-450
First Submitted:	December 14, 2006
First Posted:	December 19, 2006
Results First Submitted:	April 28, 2009
Results First Posted:	September 11, 2009
Last Update Posted:	September 22, 2009

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