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

Condition(s) targeted: Hypertension

Intervention: amlodipine and olmesartan medoxomil tablets (Drug); hydrochlorothiazide tablets (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Daiichi Sankyo Inc.

Overall contact:
Julie B Tobin, Phone: 623-271-9334, Email: julie.tobin@integrium.com

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.

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 design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: The percent of patients who achieve cuff systolic blood pressure goal (<140 mm Hg for non-diabetics and <130 mm Hg for diabetics) during the dual combination period

Secondary outcome:

The percentage of subjects achieving cuff diastolic BP goal (<90 mmHg for non-diabetics or < 80 mmHg for subjects with diabetes) during the dual-combination period

The percentage of subjects who achieve cuff BP goal (<140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics

The percentage of subjects who achieve cuff BP goal (<140/90 mmHg for non-diabetics or <130/80 mmHg for diabetics

Change from baseline in mean cuff systolic BP

Change from baseline in mean cuff diastolic BP

Percentage of patients achieving cuff Systolic BP goal of <140 mm HG

Percentage of patients achieving cuff Systolic BP goal of <135 mm HG

Percentage of patients achieving cuff Systolic BP goal of <130 mm HG

Percentage of patients achieving cuff Systolic BP goal of <120 mm HG

Percentage of patients achieving cuff Diastolic BP goal of <90 mm HG

Percentage of patients achieving cuff Diastolic BP goal of <85 mm HG

Percentage of patients achieving cuff Diastolic BP goal of <80 mm HG

Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <140/90 mm Hg

Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <135/85 mm Hg

Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <130/80 mm Hg

Percentage of patients achieving cuff systolic BP/Diastolic BP goal of <120/80 mm Hg

Number and percentage of patients achieving cuff systolic BP drop of <= to 15 mm Hg

Number and percentage of patients achieving cuff systolic BP drop of < 15 mm Hg to <= 30 mm Hg

Number and percentage of patients achieving cuff systolic BP drop of < 30 mm Hg to <= 45 mm Hg

Number and percentage of patients achieving cuff systolic BP drop of < 30 mm Hg to <= 45 mm Hg

Number and percentage of patients achieving cuff systolic BP drop of > 45 mm Hg

Number and percentage of patients achieving cuff diastolic BP drop of <= 10 mm Hg

Number and percentage of patients achieving cuff diastolic BP drop of <10 to <= 15 mm Hg

Number and percentage of patients achieving cuff diastolic BP drop of <15 to <= 20 mm Hg

Number and percentage of patients achieving cuff diastolic BP drop of >20 mm Hg

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Julie B Tobin, Phone: 623-271-9334, Email: julie.tobin@integrium.com

Birmingham, Alabama, United States; Recruiting

Tucson, Arizona, United States; Recruiting

Green Valley, Arizona, United States; Recruiting

Mesa, Arizona, United States; Recruiting

Sierra Vista, Arizona, United States; Recruiting

Tempe, Arizona, United States; Recruiting

Anaheim, California, United States; Recruiting

Harbor City, California, United States; Recruiting

National City, California, United States; Recruiting

Tustin, California, United States; Recruiting

Westlake Village, California, United States; Recruiting

Pueblo, Colorado, United States; Recruiting

Colorado Springs, Colorado, United States; Recruiting

Milford, Connecticut, United States; Recruiting

Sarasota, Florida, United States; Recruiting

Kissimmee, Florida, United States; Recruiting

Boynton Beach, Florida, United States; Recruiting

Brooksville, Florida, United States; Recruiting

Clearwater, Florida, United States; Recruiting

Deerfield Beach, Florida, United States; Recruiting

DeLand, Florida, United States; Recruiting

Fort Lauderdale, Florida, United States; Recruiting

Pembroke Pines, Florida, United States; Recruiting

St. Petersburg, Florida, United States; Recruiting

Tampa, Florida, United States; Recruiting

Boise, Idaho, United States; Recruiting

Eddison, Illinois, United States; Recruiting

Orland Park, Illinois, United States; Recruiting

Wichita, Kansas, United States; Recruiting

Lexington, Kentucky, United States; Recruiting

Columbia, Maryland, United States; Recruiting

Elkridge, Maryland, United States; Recruiting

Oxon Hill, Maryland, United States; Recruiting

Reisterstown, Maryland, United States; Recruiting

Stevensville, Michigan, United States; Recruiting

Omaha, Nebraska, United States; Recruiting

Las Vegas, Nevada, United States; Recruiting

Edison, New Jersey, United States; Recruiting

Sewell, New Jersey, United States; Recruiting

Albuquerque, New Mexico, United States; Recruiting

Binghamton, New York, United States; Recruiting

Cary, North Carolina, United States; Recruiting

Charlotte, North Carolina, United States; Recruiting

Harrisburg, North Carolina, United States; Recruiting

Hickory, North Carolina, United States; Recruiting

High Point, North Carolina, United States; Recruiting

Raleigh, North Carolina, United States; Recruiting

Wilmington, North Carolina, United States; Recruiting

Winston-Salem, North Carolina, United States; Recruiting

Cincinnati, Ohio, United States; Recruiting

Cleveland, Ohio, United States; Recruiting

Tulsa, Oklahoma, United States; Recruiting

Norman, Oklahoma, United States; Recruiting

Oklahoma City, Oklahoma, United States; Recruiting

Eugene, Oregon, United States; Recruiting

Portland, Oregon, United States; Recruiting

Havertown, Pennsylvania, United States; Recruiting

Jenkintown, Pennsylvania, United States; Recruiting

Pittsburgh, Pennsylvania, United States; Recruiting

Greenville, South Carolina, United States; Recruiting

Mt. Pleasant, South Carolina, United States; Recruiting

New Tazewell, Tennessee, United States; Recruiting

Dallas, Texas, United States; Recruiting

Amarillo, Texas, United States; Recruiting

Austin, Texas, United States; Recruiting

Carrollton, Texas, United States; Recruiting

Corpus Christi, Texas, United States; Recruiting

Longview, Texas, United States; Recruiting

West Jordan, Utah, United States; Recruiting

Norfolk, Virginia, United States; Recruiting

Walla Walla, Washington, United States; Recruiting

Madison, Wisconsin, United States; Recruiting

Starting date: November 2008
Ending date: December 2009
Last updated: February 6, 2009