An Examination of the Blood Pressure Lowering Ability and Safety of Olmesartan Medoxomil in Elderly Patients With Hypertension

Completed · Phase 4

Conditions studied: Hypertension

In brief

This 14 week study will examine the ability of olmesartan medoxomil to lower the blood pressure of patients 65 years of age or older with high blood pressure. The medication being tested has been approved by the FDA for the treatment of high blood pressure.

Key facts

Study ID

NCT00412932

Run by

Daiichi Sankyo

People needed

178

Starts

2006-12-01

Expected to finish

2008-04-01

Last updated by the study team

2009-09-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or Females greater than 65 years of age
• Patients with a mean seated systolic blood pressure (MSSBP) greater than or equal to 150 mmHg but less than 200 mm Hg and a mean seated diastolic blood pressure (MSDBP) less than or equal to 109 mmHg following a 2-3 week single blind placebo run-in period.
• The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmHg.
• Patients with a mean daytime (8am-4pm) systolic blood pressure (SBP) greater than or equal to 140 mmHg and less than or equal to 199 mmHg and a mean daytime diastolic blood pressure (DBP) less than or equal to 109 mmHg as measured by an ambulatory blood pressure monitoring device (ABPM) following placebo run-in period.

You may not qualify if…

• History of stroke or transient ischemic attack (TIA) within the last one year.
• History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months.
• Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure greater than or equal to 200 mmHg).
• Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or Cushing's syndrome.
• Type I diabetes or Type II diabetics not on stable treatment for greater than or equal to 4 weeks and plasma glucose greater than 160 mg/dl.
• Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease.
• Presence of heart block greater than first degree sinoatrial block, Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, an accessory bypass tract, atrial fibrillation, atrial flutter or any arrhythmia requiring medication.
• Serum Creatinine greater than 1.7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.

Where it is running

• Study site — Birmingham, Alabama, United States
• Study site — Mesa, Arizona, United States
• Study site — Long Beach, California, United States
• Study site — Los Angeles, California, United States
• Study site — Pomona, California, United States
• Study site — Roseville, California, United States
• Study site — Tustin, California, United States
• Study site — Farmington, Connecticut, United States
• Study site — Jupiter, Florida, United States
• Study site — Lauderdale Lakes, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Wichita, Kansas, United States
• Study site — Madisonville, Kentucky, United States
• Study site — Auburn, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Oxon Hill, Maryland, United States
• Study site — Florissant, Missouri, United States
• Study site — Berlin, New Jersey, United States
• Study site — Williamsville, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Cincinnati, Ohio, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Greer, South Carolina, United States

Full record on ClinicalTrials.gov

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