Clinical trial NCT00791258: A Dose Escalation Study of a Combination Antihypertensive Drug in the Treatment of Various Groups of Patients Who do Not Respond to Single Drug Treatment of Their High Blood Pressure
Official title: A Prospective, Open-Label, Titration Study to Evaluate the Efficacy and Safety Safety of AZOR in Multiple Subgroups of Hypertensive Subjects Who Are Non-Responders to Anti-Hypertensive Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Integrium
First posted: 2008-11-14
Enrollment: 999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.


Eligibility criteria: Inclusion Criteria:

* \>= to 18 years of age
* Hypertension uncontrolled on current monotherapy
* Females:
* negative serum pregnancy test at screening
* post menopausal or have had a hysterectomy or tubal ligation or practicing approved methods of birth control

Exclusion Criteria:

* Pregnant females
* Uncontrolled hypertension with multiple drugs, except for hydrochlorothiazide/triamterene
* Diabetes requiring insulin
* Serious disorders that may limit the ability to evaluate the efficacy or safety of treatment
* History of myocardial infarction, bypass graft, angioplasty or heart failure within the past 6 months
* History of Class III or IV congestive heart failure
* History of stroke or transient ischemic attack within the last 1 year

Primary outcomes:
measure: The Percentage of Patients Who Achieve Seated Systolic Blood Pressure Goal (<140 mm Hg for Non-diabetics and <130 mm Hg for Diabetics) From Baseline to 12 Weeks
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: The Percentage of Subjects Achieving Seated Diastolic BP Goal (<90 mmHg for Non-diabetics or < 80 mmHg for Subjects With Diabetes) From Baseline to 12 Weeks
timeFrame: baseline to 12 weeks
measure: The Percentage of Subjects Who Achieve BP Goal (<140/90 mmHg for Non-diabetics or <130/80 mmHg for Diabetics) From Baseline to 12 and 20 Weeks
timeFrame: Baseline to 12 and 20 weeks
measure: Change in Mean Seated Systolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Change in Mean Seated Diastolic Blood Pressure From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Achieving the Mean Daytime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Achieving the Mean Nighttime Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Achieving the Mean 24-hour Blood Pressure Goals, as Measured by Ambulatory Blood Pressure Monitor, From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Change From Baseline to Week 12 in Ambulatory Systolic and Diastolic Blood Pressure Values
timeFrame: Baseline to 12 weeks
measure: Change From Baseline to Week 20 in Ambulatory Systolic and Diastolic Blood Pressure Values
timeFrame: Baseline to 20 weeks
measure: Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of African American/Black Patients Achieving Seated Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of African American/Black Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of African American/Black Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Asain Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Asian Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Asian Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Hispanic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Hispanic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Elderly Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Elderly Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Type 2 Diabetic Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Type 2 Diabetic Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Obese Patients Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Obese Patients Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Goal From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients With Metabolic Syndrome Achieving Seated Systolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Patients With Metabolic Syndrome Achieving Seated Diastolic Blood Pressure Reduction Ranges From Baseline to 4, 8, 12, 16, 20 Weeks
timeFrame: Baseline to 4, 8, 12, 16, 20 weeks
measure: Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Previously on a Dihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Previously on a Diuretic Achieving the Blood Pressure Goals From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Previously on an Angiotensin Converting Enzyme Inhibitor Achieving the Blood Pressure Goals From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Previously on an Angiotensin II Receptor Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Previously on a Beta Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
measure: Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 12 Weeks
timeFrame: Baseline to 12 weeks
measure: Percentage of Participants Previously on a Nondihydropyridine Calcium Channel Blocker Achieving the Blood Pressure Goals From Baseline to 20 Weeks
timeFrame: Baseline to 20 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Green Valley
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Sierra Vista
country: United States
state: Arizona
city: Tempe
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Harbor City
country: United States
state: California
city: National City
country: United States
state: California
city: Tustin
country: United States
state: California
city: Westlake Village
country: United States
state: California
city: Colorado Springs
country: United States
state: Colorado
city: Pueblo
country: United States
state: Colorado
city: Milford
country: United States
state: Connecticut
city: Boynton Beach
country: United States
state: Florida
city: Brooksville
country: United States
state: Florida
city: Clearwater
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: DeLand
country: United States
state: Florida
city: Fort Lauderdale
country: United States
state: Florida
city: Kissimmee
country: United States
state: Florida
city: Pembroke Pines
country: United States
state: Florida
city: Saint Petersburg
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Boise
country: United States
state: Idaho
city: Addison
country: United States
state: Illinois
city: Orland Park
country: United States
state: Illinois
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: Columbia
country: United States
state: Maryland
city: Elkridge
country: United States
state: Maryland
city: Oxon Hill
country: United States
state: Maryland
city: Reisterstown
country: United States
state: Maryland
city: Stevensville
country: United States
state: Michigan
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Edison
country: United States
state: New Jersey
city: Sewell
country: United States
state: New Jersey
city: Albuquerque
country: United States
state: New Mexico
city: Binghamton
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Harrisburg
country: United States
state: North Carolina
city: Hickory
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cleveland
country: United States
state: Ohio
city: Norman
country: United States
state: Oklahoma
city: Oklahoma City
country: United States
state: Oklahoma
city: Tulsa
country: United States
state: Oklahoma
city: Eugene
country: United States
state: Oregon
city: Portland
country: United States
state: Oregon
city: Havertown
country: United States
state: Pennsylvania
city: Jenkintown
country: United States
state: Pennsylvania
city: Pittsburgh
country: United States
state: Pennsylvania
city: Greenville
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: New Tazewell
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Austin
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Corpus Christi
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Longview
country: United States
state: Texas
city: West Jordan
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Walla Walla
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
Study officials:
References:
citation: Nesbitt SD, Shojaee A, Maa JF, Weir MR. Efficacy of an amlodipine/olmesartan treatment algorithm in patients with or without type 2 diabetes and hypertension (a secondary analysis of the BP-CRUSH study). J Hum Hypertens. 2013 Jul;27(7):445-52. doi: 10.1038/jhh.2012.65. Epub 2012 Dec 20.
citation: Hsueh WA, Shojaee A, Maa JF, Neutel JM. Efficacy of amlodipine/olmesartan medoxomil +/- HCTZ in obese patients uncontrolled on antihypertensive monotherapy. Curr Med Res Opin. 2012 Nov;28(11):1809-18. doi: 10.1185/03007995.2012.740632. Epub 2012 Oct 30.