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This 16 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients with moderate to severe high blood pressure in comparison to placebo. The medication being tested has been approved by the FDA for the treatment of high blood pressure.
This study was to randomize an equal number of participants to either an olmesartan medoxomil based treatment or to placebo. The titration scheme was as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Olmesartan medoxomil, plus hydrochlorothiazide, if necessary |
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| Placebo | Placebo Comparator | Placebo tablets were taken once daily for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| olmesartan medoxomil + hydrochlorothiazide, if necessary | Drug | olmesartan medoxomil + hydrochlorothiazide, if necessary. Oral tablets administered for once daily for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group. | baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach. | baseline to 12 weeks |
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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 |
|---|---|---|---|
| 20653330 | Result | Kereiakes DJ, Maa JF, Shojaee A, Dubiel R. Effect of an olmesartan medoxomil-based treatment algorithm on systolic blood pressure in patients with stage 1 or 2 hypertension: a randomized, double-blind, placebo-controlled study. Am J Cardiovasc Drugs. 2010;10(4):239-46. doi: 10.2165/11538630-000000000-00000. | |
| 19120717 | Result |
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After 3-4 weeks of placebo treatment, eligible subjects were randomized. 140 were randomized to drug; 138 to placebo. 2 active drug participants were given the wrong dose at entry. Because only 138 participants received Olmesartan 20 mg, any demography data totals are equal to 276 instead of 278. The subgroup analyses are similarly affected.
Subjects were recruited at 29 US sites (private medical practices and small clinics) over 5 months from December 2006 to May 2007 from each physician's clientele base. About 450 potential subjects were to be screened so that about 250 eligible subjects, men and women at least 18 years of age with stage I or II hypertension, were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo (Pbo) Group | 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | Oral tablets administered for once daily for 12 weeks |
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| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males. | The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed. | Baseline to week 12 |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females. | The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed. | Baseline to week 12 |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old. | Baseline to 12 weeks |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old. | Baseline to 12 weeks |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants. | Baseline to week 12 |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants. | Baseline to 12 weeks |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives | Baseline to 12 weeks |
| The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives | Baseline to 12 months |
| Mobile |
| Alabama |
| United States |
| Muscle Shoals | Alabama | United States |
| Searcy | Arkansas | United States |
| Carmichael | California | United States |
| Spring Valley | California | United States |
| Coral Gables | Florida | United States |
| Deerfield Beach | Florida | United States |
| DeLand | Florida | United States |
| Fort Lauderdale | Florida | United States |
| Hialeah | Florida | United States |
| Hollywood | Florida | United States |
| Pembroke Pines | Florida | United States |
| Chicago | Illinois | United States |
| Elizabeth | New Jersey | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Eugene | Oregon | United States |
| Downingtown | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Nashville | Tennessee | United States |
| New Tazewell | Tennessee | United States |
| Colleyville | Texas | United States |
| San Antonio | Texas | United States |
| Murray | Utah | United States |
| Manassas | Virginia | United States |
| Olympia | Washington | United States |
| Madison | Wisconsin | United States |
| Oparil S, Chrysant SG, Kereiakes D, Xu J, Chavanu KJ, Waverczak W, Dubiel R. Results of an olmesartan medoxomil-based treatment regimen in hypertensive patients. J Clin Hypertens (Greenwich). 2008 Dec;10(12):911-21. doi: 10.1111/j.1751-7176.2008.00045.x. |
| FG001 | Olmesartan Group | 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg. |
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| ID | Title | Description |
|---|---|---|
| BG000 | Olmesartan Group | Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12). |
| BG001 | Placebo Group | Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment. |
| BG002 | Total | Total of all reporting groups |
| 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 | Full Range | 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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| Diastolic BP | Mean | Full Range | mm Hg |
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| Heart Rate | Mean | Full Range | Beats/minute |
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| Systolic BP | Mean | Full Range | 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 Systolic Blood Pressure (SBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | The change from baseline in mean systolic blood pressure (SBP) after 12 weeks of randomized treatment was compared between the olmesartan based treatment group and the placebo treatment group. | The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group. 139 is the correct number analyzed. For the placebo group the efficacy cohort = 137. | Posted | Least Squares Mean | Standard Error | mm Hg | baseline to 12 weeks |
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| Secondary | Change From Baseline in Mean Diastolic Blood Pressure (DBP) After 12 Weeks of Randomized Treatment as Measured by Omron Device. | Change from study baseline (average of triplicate DBP measurements at the last 2 qualifying visits during placebo run-in period) in DBP to the end of 12 weeks of randomized treatment using a last observation carried forward (LOCF) approach. | The efficacy cohort is defined as any subject who received at least 1 dose of randomized study medication and had a baseline and at least 1 post-baseline efficacy blood pressure assessment. 140 participants were originally randomized to the olmesartan group, but two were erroneously started with the 40mg dose. 139 is the correct number analyzed. | Posted | Least Squares Mean | Standard Error | mm Hg | baseline to 12 weeks |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Males. | The difference in the change from baseline to week 12 in seated systolic and diastolic blood pressure for males in the olmesartan group vs. the placebo group was analyzed. | 131 male participants | Posted | Least Squares Mean | Standard Error | mm Hg | Baseline to week 12 |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Females. | The difference in the change from baseline to week 12 in seated blood pressure for females in the olmesartan group vs. the placebo group was analyzed. | 145 female participants from both the olmesartan and placebo groups were analyzed. | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to week 12 |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Less Than 65 Years Old. | 232 participants from both the olmesartan and placebo groups, less than 65 years of age, were analyzed. | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to 12 weeks |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Participants Greater Than or Equal to 65 Years Old. | 44 participants of greater than 65 years of age, from both the olmesartan and placebo groups were analyzed. | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to 12 weeks |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Black Participants. | 55 Black participants from both the olmesartan and placebo groups were analyzed. | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to week 12 |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Non-Black Participants. | 221 non-Black participants from both the olmesartan and placebo groups were analyzed. | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to 12 weeks |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 1 Hypertensives | 130 Stage 1 hypertensive participants from both the olmesartan and placebo groups. | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to 12 weeks |
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| Secondary | The Difference in the Change From Baseline to Week 12 in Seated Systolic and Diastolic Blood Pressure Between the Olmesartan Group and the Placebo Group for Stage 2 Hypertensives | 146 Stage 2 hypertensive participants from both the olmesartan and placebo groups | Posted | Least Squares Mean | Standard Deviation | mm Hg | Baseline to 12 months |
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12-week randomized, treatment period plus 30 days after the last dose of study medication.
All adverse events (whether observed by the Investigator or reported by the subject) were recorded on the Adverse Event page of the CRF with details of the following: date, time of onset, duration, severity, relationship to study drug, action taken with respect to the study drug, treatments administered, outcome, and seriousness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo (Pbo) Group | 138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg. | 0 | 138 | 46 | 138 | ||
| EG001 | Olmesartan Group | 140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg. | 3 | 140 | 55 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
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| Small Intestine Obstruction | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA (9.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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| Viral upper respiratory infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
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If identified by Daiichi Sankyo Inc.(DSI), any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving DSI any right of editorial control over any publication prepared by the study site.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Clinical Leader | Daiichi Sankyo | 1-908-992-6400 |
| 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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| Title | Denominators | Categories | ||||
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| Systolic Blood Pressure |
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| Diastolic Blood Pressure |
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