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

Completed · Phase 4

Conditions studied: Hypertension

In brief

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.

Key facts

Study ID

NCT00791258

Run by

Daiichi Sankyo

People needed

999

Starts

2008-11-01

Expected to finish

2009-09-01

Last updated by the study team

2019-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >= 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

You may not qualify if…

• 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

Where it is running

• Study site — Green Valley, Arizona, United States
• Study site — Mesa, Arizona, United States
• Study site — Sierra Vista, Arizona, United States
• Study site — Tempe, Arizona, United States
• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Harbor City, California, United States
• Study site — National City, California, United States
• Study site — Tustin, California, United States
• Study site — Westlake Village, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Pueblo, Colorado, United States
• Study site — Milford, Connecticut, United States
• Study site — Boynton Beach, Florida, United States
• Study site — Brooksville, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — DeLand, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Kissimmee, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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