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This study will be conducted to assess the efficacy and safety of an amlodipine/olmesartan treatment regimen in stage 1 and stage 2 hypertensive subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine | Drug | Tablets |
| |
| Olmesartan medoxomil plus amlodipine |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring | Baseline to 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure | Baseline to 12 weeks | |
| Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group. | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buena Park | California | United States | ||||
After placebo treatment, participants with a mean systolic blood pressure (SBP)≥140 mmHg and ≤199 mmHg or a mean diastolic BP (DBP)≥90 and ≤109 mmHg with a difference between mean SBPs ≤15 mmHg and a mean 8-hr daytime SBP of ≥135 mmHg and ≤199 mmHg, and mean 8-hr daytime DBP of <110 mmHg by ambulatory BP monitoring were considered eligible.
Participants were recruited at 18 US sites over 4 months (September 2007 to December 2007) from each physician's clientele base. Approximately 150 eligible participants, men and women at least 18 years of age with hypertension or uncontrolled hypertension on current medication, were to receive active treatment
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| ID | Title | Description |
|---|---|---|
| FG000 | Amlodipine and Olmesartan, if Necessary | All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Weeks 1-3: Amlodipine (Aml) 5mg |
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| Drug |
Tablets |
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| Baseline to end of week 3 |
| Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group. | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | Baseline to end of week 6 |
| Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | Baseline to end of week 9 |
| Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | Baseline to end end of week 12 |
| Long Beach |
| California |
| United States |
| Los Angeles | California | United States |
| Sacramento | California | United States |
| Tustin | California | United States |
| Westlake Village | California | United States |
| Castle Rock | Colorado | United States |
| Pembroke Pines | Florida | United States |
| Orland Park | Illinois | United States |
| Natick | Massachusetts | United States |
| New York | New York | United States |
| Winston-Salem | North Carolina | United States |
| Cincinnati | Ohio | United States |
| Beaver | Pennsylvania | United States |
| Greer | South Carolina | United States |
| Carrolton | Texas | United States |
| Corpus Christi | Texas | United States |
| Madison | Wisconsin | United States |
| COMPLETED |
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| NOT COMPLETED |
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| Weeks 4-6: Aml 5mg+Olmesartan 20 mg |
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| Weeks 7-9: Aml 5 mg + Olmesartan 40 mg |
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| Weeks 10-12:Aml 10 mg +Olmesartan 40 mg |
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| ID | Title | Description |
|---|---|---|
| BG000 | Amlodipine and Olmesartan, if Necessary | Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP >= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP >= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP >= 120/80 mm Hg |
| Units | Counts |
|---|---|
| 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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| Race/Ethnicity, Customized | Number | Participants |
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| Region of Enrollment | Number | participants |
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| 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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| 24-Hour Ambulatory Diastolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| 24-hour Ambulatory Systolic Blood Pressure | Mean | Standard Deviation | mm Hg |
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| Heart Rate | Mean | Standard Deviation | beats/minute |
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| Systolic Blood Pressure | Seated cuff measurement as opposed to ambulatory measurement. | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Mean 24-hour Systolic Blood Pressure Measured by Ambulatory Monitoring | The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline to 12 Weeks |
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| Secondary | Change From Baseline in Daytime and Nighttime Ambulatory Systolic Blood Pressure | The ambulatory blood pressure monitoring (ABPM) subset were subjects who received at least one dose of active study medication and had a baseline ABPM and end of study ABPM measurement.This = 172 participants. | Posted | Mean | Standard Deviation | mm Hg | Baseline to 12 weeks |
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| Secondary | Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg Group. | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | ITT (efficacy cohort) | Posted | Mean | Standard Deviation | mm Hg | Baseline to end of week 3 |
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| Secondary | Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 20 mg Group. | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | ITT (efficacy cohort) | Posted | Mean | Standard Error | mm Hg | Baseline to end of week 6 |
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| Secondary | Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 5mg + Olmesartan 40 mg Group | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | ITT (efficacy cohort) | Posted | Mean | Standard Error | mm Hg | Baseline to end of week 9 |
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| Secondary | Change From Baseline in Cuff Systolic Blood Pressure for the Amlodipine 10 mg + Olmesartan 40 mg Group | Change from study baseline in cuff systolic pressure (as measured by an Omron device) to the end of the treatment period. The Last Observation Carried Forwarded (LOCF) approach was used for the analysis. | ITT (efficacy cohort) | Posted | Mean | Standard Error | mm Hg | Baseline to end end of week 12 |
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12 week treatment period plus 30 days after the last dose.
Adverse events (AEs)were collected from the time of signing informed consent to the study and followup period (30 days). AEs were observed by the investigator (Inv) or reported by the participant. The nature of the event, time of onset, duration and intensity were documented together with the Inv assessment of the causal relationship to the drug.
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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 | Amlodipine 5 mg | All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12. | 0 | 185 | 8 | 185 | ||
| EG001 | Amlodipine 5mg and Olmesartan 20 mg | All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12. | 0 | 180 | 23 | 180 | ||
| EG002 | Amlodipine 5mg and Olmesartan 40 mg | All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12. | 1 | 161 | 11 | 161 | ||
| EG003 | Amlodipine 10 mg and Olmesartan 40 mg | All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12. | 1 | 134 | 12 | 134 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Limb amputation | Injury, poisoning and procedural complications | MedDRA (10.1) | Systematic Assessment |
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| Transient ischemic attack | Vascular disorders | MedDRA (10.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | MedDRA (10.1) | Systematic Assessment |
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| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (10.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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| Oedema Peripheral | General disorders | MedDRA (10.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (10.1) | Systematic Assessment |
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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 any right of editorial control over any publication prepared by 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 |
|---|---|
| D017311 | Amlodipine |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
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| White |
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| American Indian or Alaska Native |
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| Nighttime |
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