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This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olmesartan medoxomil | Drug | Tablets | ||
| Olmesartan medoxomil/hydrochlorothiazide | Drug | Tablets |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment. | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22920048 | Derived | 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: 10.1007/BF03261841. | |
| 21639407 | Derived |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Olmesartan (Olm) 20 mg |
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| baseline to 12 weeks |
| Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | baseline to 12 weeks |
| 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 | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | baseline to 12 weeks |
| 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 | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | baseline to 12 weeks |
| 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. | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | baseline to 12 weeks |
| 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. | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | baseline to 12 weeks |
| Mesa |
| Arizona |
| United States |
| Long Beach | California | United States |
| Los Angeles | California | United States |
| Pomona | California | United States |
| Roseville | California | United States |
| Tustin | California | United States |
| Farmington | Connecticut | United States |
| Jupiter | Florida | United States |
| Lauderdale Lakes | Florida | United States |
| New Port Richey | Florida | United States |
| Pembroke Pines | Florida | United States |
| Chicago | Illinois | United States |
| Wichita | Kansas | United States |
| Madisonville | Kentucky | United States |
| Auburn | Maine | United States |
| Baltimore | Maryland | United States |
| Oxon Hill | Maryland | United States |
| Florissant | Missouri | United States |
| Berlin | New Jersey | United States |
| Williamsville | New York | United States |
| Charlotte | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Greer | South Carolina | United States |
| Corpus Christi | Texas | United States |
| Richardson | Texas | United States |
| Norfolk | Virginia | United States |
| Madison | Wisconsin | United States |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Olmesartan 40 mg |
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| Olm+Hydrochlorothiazide 12.5 mg |
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| Olm+ Hydrochlorothiazide 25 mg |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline stage of hypertension | 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. | Number | participants |
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| Baseline 24-hour ambulatory diastolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Baseline 24-hour ambulatory systolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Baseline diastolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Baseline heart rate | Mean | Standard Deviation | beats/minute |
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| Baseline systolic blood pressure | Mean | Standard Deviation | mm Hg |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Mean | Standard Error | mm Hg | baseline to 12 weeks |
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| Secondary | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment. | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Mean | Standard Error | mm Hg | baseline to 12 weeks |
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| Secondary | Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Mean | Standard Error | mm Hg | baseline to 12 weeks |
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| 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 | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Mean | Standard Error | mm Hg | baseline to 12 weeks |
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| 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 | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Number | participants | baseline to 12 weeks |
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| 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. | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Number | participants | baseline to 12 weeks |
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| 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. | All participants started the treatment arm with 20 mg olmesartan medoxomil (Olm). If their blood pressure was not controlled, participants were titrated at 3-week intervals to: Olm 40 mg, then, if needed Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg, then, if needed Olm 40 mg + HCTZ 25 mg This outcome measure included all participants at the end of the 12-week treatment period regardless of whether or not they were titrated. They had to have both baseline and 12-week ambulatory blood pressure measurements. | 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. | Posted | Number | participants | baseline to 12 weeks |
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"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."
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Raia | Daiichi Sankyo | 973-630-2683 | jraia@dsus.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D000068557 | Olmesartan Medoxomil |
| D006852 | Hydrochlorothiazide |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013777 | Tetrazoles |
| D002740 | Chlorothiazide |
| D001581 | Benzothiadiazines |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D049971 | Thiazides |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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