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

Information source: Daiichi Sankyo Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Olmesartan medoxomil (Drug); Olmesartan medoxomil/hydrochlorothiazide (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Daiichi Sankyo Inc.

Summary

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.

Clinical Details

Official title: A Prospective, Open Label, Single Arm Study to Evaluation the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients With Hypertension

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment

Secondary outcome:

Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure After 12 Weeks of Active Treatment.

Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10pm-6am)Ambulatory Systolic Blood Pressure After 12 Weeks of Active Treatment

Change From Baseline in Mean Daytime (8am-4pm) and Mean Nighttime (10 Pm-6am) Ambulatory Blood Pressure Monitored Diastolic Blood Pressure After 12 Weeks of Active Treatment

Number of Subjects Who Achieved Mean 24-hour Ambluatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment

Number of Subjects Who Achieved Mean Daytime (8am - 4pm) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.

Number of Subjects Who Achieved Mean Nighttime (10pm - 6am) Ambulatory Blood Pressure of <140/90 mm Hg, Systolic Blood Pressure <140 mm Hg, and Diastolic Blood Pressure <90 mm Hg After 12 Weeks of Active Treatment.

Eligibility

Minimum age: 65 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Males or Females greater than 65 years of age 2. 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. 3. The difference in MSSBP between visits 2 and 3 or between visits 3 and 3x must be less than or equal to 10 mmHg. 4. 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. Exclusion Criteria: 1. History of stroke or transient ischemic attack (TIA) within the last one year. 2. History of myocardial infarction, angina, coronary angioplasty, coronary artery bypass graft, or heart failure within the past 6 months. 3. Severe hypertension (diastolic blood pressure greater than 115 mmHg or systolic blood pressure greater than or equal to 200 mmHg). 4. Patients with secondary hypertension of any etiology, such as renal disease, pheochromocytoma or Cushing's syndrome. 5. 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. 6. Evidence of symptomatic resting bradycardia, congestive heart failure, or hemodynamically significant cardiac valvular disease. 7. 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. 8. Serum Creatinine greater than 1. 7 mg/dl, or other abnormal laboratory values deemed clinically significant by the investigator.

Locations and Contacts

Birmingham, Alabama, United States

Mesa, Arizona, United States

Long Beach, California, United States

Los Angeles, California, United States

Pomona, California, United States

Roseville, California, United States

Tustin, California, United States

Farmington, Connecticut, United States

Jupiter, Florida, United States

Lauderdale lakes, Florida, United States

New Port Richey, Florida, United States

Pembroke Pines, Florida, United States

Chicago, Illinois, United States

Wichita, Kansas, United States

Madisonville, Kentucky, United States

Auburn, Maine, United States

Baltimore, Maryland, United States

Oxon Hill, Maryland, United States

Florissant, Missouri, United States

Berlin, New Jersey, United States

Williamsville, New York, United States

Charlotte, North Carolina, United States

Cincinnati, Ohio, United States

Oklahoma City, Oklahoma, United States

Greer, South Carolina, United States

Corpus Christi, Texas, United States

Richardson, Texas, United States

Norfolk, Virginia, United States

Madison, Wisconsin, United States

Additional Information

Starting date: December 2006
Last updated: September 15, 2009

Page last updated: August 20, 2015

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