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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
Enrollment 178
Recruitment Details 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 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
Arm/Group Title Active Treatment Period
Hide Arm/Group Description 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.
Period Title: Olmesartan (Olm) 20 mg
Started 178
Completed 171
Not Completed 7
Reason Not Completed
Adverse Event             1
Lack of Efficacy             2
Protocol Violation             1
Withdrawal by Subject             2
Other             1
Period Title: Olmesartan 40 mg
Started 169 [1]
Completed 161
Not Completed 8
Reason Not Completed
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 Title: Olm+Hydrochlorothiazide 12.5 mg
Started 159 [1]
Completed 153
Not Completed 6
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             3
[1]
161 -2 met blood pressure goal (stayed on olmesartan 40) = 159
Period Title: Olm+ Hydrochlorothiazide 25 mg
Started 125 [1]
Completed 123
Not Completed 2
Reason Not Completed
Adverse Event             1
Lost to Follow-up             1
[1]
153 -28 met their blood pressure goal (stayed on olmesartan 40/hydrochlorothiazide 12.5) = 125
Arm/Group Title Active Treatment Period
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 178
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 178 participants
72.0  (5.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 178 participants
Female
85
  47.8%
Male
93
  52.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 178 participants
178
Baseline stage of hypertension   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 178 participants
Stage 1 hypertension 62
Stage 2 hypertension 116
[1]
Measure Description: 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  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 178 participants
80.7  (8.5)
Baseline 24-hour ambulatory systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 178 participants
149.1  (11.2)
Baseline diastolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 178 participants
87.7  (9.6)
Baseline heart rate  
Mean (Standard Deviation)
Unit of measure:  Beats/minute
Number Analyzed 178 participants
71.5  (11.4)
Baseline systolic blood pressure  
Mean (Standard Deviation)
Unit of measure:  Mm Hg
Number Analyzed 178 participants
165.5  (11.9)
1.Primary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Mean (Standard Error)
Unit of Measure: mm Hg
-25.7  (0.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments The sample size of this study was not based on the statistical power consideration and was considered as sufficient for the evaluation of the efficacy and safety of the proposed olmesartan medoxomil-based treatment regimen.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No multiplicity adjustments
Method one-sample t-test
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.
Time Frame baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Mean (Standard Error)
Unit of Measure: mm Hg
-12.3  (0.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method One-sample t-test
Comments [Not Specified]
3.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Mean (Standard Error)
Unit of Measure: mm Hg
Daytime -26.5  (1.10)
Nighttime -24.4  (1.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No multiplicity adjustments. This P-Value applies to both the daytime and nighttime periods.
Method one-sample t-test
Comments [Not Specified]
4.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had baseline and week 12 ABPM measurements.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Mean (Standard Error)
Unit of Measure: mm Hg
Daytime -13.0  (0.65)
Nighttime -11.5  (0.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Overall Study
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments No multiplicity adjustments. The P-Value of <0.0001 applies to both daytime and nighttime periods.
Method one-sample t-test
Comments [Not Specified]
5.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
BP<140/90 mm Hg 133
SBP<140 mm Hg 133
DBP<90 mm Hg 149
6.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
BP<140/90 mm Hg 120
SBP<140 mm Hg 120
DBP<90 mm Hg 145
7.Secondary Outcome
Title 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
Hide Outcome Measure Data
Hide Analysis Population Description
178 participants started the active treatment period. 23 dropped out. 150=The ambulatory blood pressure monitoring (ABPM) subset was defined as subjects who received at least one dose of active study medication and had a baseline and week 12 ABPM.
Arm/Group Title Overall Study
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 150
Measure Type: Number
Unit of Measure: participants
BP<140/90 mm Hg 143
SBP<140 mm Hg 143
DBP<90 mm Hg 149
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.
"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
Layout table for Results Point of Contact information
Name/Title: John Raia
Organization: Daiichi Sankyo
Phone: 973-630-2683
EMail: jraia@dsus.com
Layout table for additonal information
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