An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
Information source: Daiichi Sankyo Inc.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypertension
Intervention: Olmesartan medoxomil (Drug); Olmesartan medoxomil/hydrochlorothiazide (Drug); Hydrochlorothiazide (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Daiichi Sankyo Inc.
Summary
Effect of increasing doses of olmesartan medoxomil and olmesartan
medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
Clinical Details
Official title: A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension
Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change in mean trough seated systolic blood pressure compared to the start of the study
Secondary outcome: 1. Blood pressure changes from baseline at the end of each titration period.2. Percentage of patients responding to therapy 3. Percentage of patients achieving various blood pressure target goals
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 Criteria:
- 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.
Locations and Contacts
Long Beach, California, United States
Westlake Village, California, United States
Roseville, California, United States
Sacramento, California, United States
Fort Lauderdale, California, United States
Santa Anna, California, United States
Tustin, California, United States
Pembroke Pines, Florida, United States
Deland, Florida, United States
Orland Park, Illinois, United States
New Orleans, Louisiana, United States
Auburn, Maine, United States
Omaha, Nebraska, United States
Buffalo, New York, United States
Oklahoma City, Oklahoma, United States
Madison, Wisconsin, United States
Additional Information
Starting date: March 2004
Ending date: October 2004
Last updated: September 9, 2005
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