An Examination of the Safety and Blood Pressure Lowering Effect of Increasing Doses of Benicar® and Benicar® HCT in Patients With Hypertension
A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension
1 other identifier
interventional
110
1 country
16
Brief Summary
Effect of increasing doses of olmesartan medoxomil and olmesartan medoxomil/hydrochlorothiazide on blood pressure in patients with hypertension
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 hypertension
Started Mar 2004
Shorter than P25 for phase_4 hypertension
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 16, 2005
CompletedSeptember 16, 2005
September 1, 2005
September 9, 2005
September 9, 2005
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean trough seated systolic blood pressure compared to the start of the study
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- \. 18 years of age.
- \. Patients with stage II systolic hypertension
- \. 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:
- \. 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.
- \. Patients with malignancy during the past 5 years excluding squamous cell or basal cell carcinoma of the skin.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
Study Sites (16)
Unknown Facility
Fort Lauderdale, California, United States
Unknown Facility
Long Beach, California, United States
Unknown Facility
Roseville, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Santa Anna, California, United States
Unknown Facility
Tustin, California, United States
Unknown Facility
Westlake Village, California, United States
Unknown Facility
DeLand, Florida, United States
Unknown Facility
Pembroke Pines, Florida, United States
Unknown Facility
Orland Park, Illinois, United States
Unknown Facility
New Orleans, Louisiana, United States
Unknown Facility
Auburn, Maine, United States
Unknown Facility
Omaha, Nebraska, United States
Unknown Facility
Buffalo, New York, United States
Unknown Facility
Oklahoma City, Oklahoma, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 16, 2005
Study Start
March 1, 2004
Study Completion
October 1, 2004
Last Updated
September 16, 2005
Record last verified: 2005-09