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

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

Official Title
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A Prospective, Open Label, Titration Study to Assess the Efficacy and Safety of Benicar® and Benicar ®HCT in Patients With Stage II Systolic Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Olmesartan medoxomil
* Drug: Olmesartan medoxomil/hydrochlorothiazide
* Drug: Hydrochlorothiazide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olmesartan medoxomil|nan|
|Drug: Olmesartan medoxomil/hydrochlorothiazide|nan|
|Drug: Hydrochlorothiazide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean trough seated systolic blood pressure compared to the start of the study |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systolic hypertension, Angiotensin receptor blocker