An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension

Completed · Phase 4

Conditions studied: Hypertension

In brief

Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension

Key facts

Study ID

NCT00185068

Run by

Daiichi Sankyo

People needed

110

Starts

2004-03-01

Expected to finish

2004-10-01

Last updated by the study team

2005-09-16

Who can join

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

You may qualify if…

• 1. 18 years of age.
• 2. Patients with stage II systolic hypertension
• 3. If female, must have negative serum pregnancy test at screening and be either post-menopausal, had a hysterectomy or tubal ligation at least 6 months before consent or if of childbearing potential, must practice approved measures of birth control throughout study.

You may not qualify if…

• 1. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.
• History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
• Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP > 200 mm Hg).
• History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
• Type I diabetes mellitus. 6. 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, Atrial fibrillation, or Atrial Flutter.
• Laboratory test values considered clinically significant by the investigator.
• Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin > 3 times the upper limit of normal.
• Pregnant or lactating females.
• 11. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.

Where it is running

• Study site — Fort Lauderdale, California, United States
• Study site — Long Beach, California, United States
• Study site — Roseville, California, United States
• Study site — Sacramento, California, United States
• Study site — Santa Anna, California, United States
• Study site — Tustin, California, United States
• Study site — Westlake Village, California, United States
• Study site — DeLand, Florida, United States
• Study site — Pembroke Pines, Florida, United States
• Study site — Orland Park, Illinois, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Auburn, Maine, United States
• Study site — Omaha, Nebraska, United States
• Study site — Buffalo, New York, United States
• Study site — Oklahoma City, Oklahoma, United States
• Study site — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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