Status:
COMPLETED
An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Hypertensive encephalopathy, stroke or transient ischemic attack (TIA) within the past 6 months.
- 2\. History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months.
- 3\. Severe hypertension (DBP greater than or equal to 110 mm Hg or SBP \> 200 mm Hg).
- 4\. History of secondary hypertension including renal disease, phaeochromocytoma, or Cushing's disease.
- 5\. Type I diabetes mellitus. 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, Atrial fibrillation, or Atrial Flutter.
- 8\. Laboratory test values considered clinically significant by the investigator.
- 9\. Evidence of liver disease as indicated by SGOT or SGPT and/or total bilirubin \> 3 times the upper limit of normal.
- 10\. Pregnant or lactating females.
- 11\. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT00185068
Start Date
March 1 2004
End Date
October 1 2004
Last Update
September 16 2005
Active Locations (16)
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1
Fort Lauderdale, California, United States
2
Long Beach, California, United States
3
Roseville, California, United States
4
Sacramento, California, United States