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

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.

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

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

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

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.

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	85
Male	93
Region of Enrollment  [Units: Participants]
United States	178
Baseline stage of hypertension [1]  [Units: Participants]
Stage 1 hypertension	62
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)

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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 ]

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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