Olmesartan in Essential Hypertension

Study Overview
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Brief Summary
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To test the efficacy and safety of olmesartan in patients with essential hypertension.

Official Title
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Efficacy and Safety of Olmesartan: Reduction of Blood Pressure in the Treatment of Patients Suffering From Mild to Moderate Essential Hypertension

Conditions
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Essential Hypertension

Intervention / Treatment
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* Other: placebo
* Drug: olmesartan medoxomil
* Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 18 (19 if required by local authorities) to 75 years Males and females of any race. Female participants must take adequate contraceptive measures (oral contraceptives, I.U.D.), be post-menopausal or surgically sterilized Essential hypertension: sitting DBP greater than or equal to 90 and less than 110 mmHg Written Informed Consent Mentally competent Negative pregnancy test in women at a childbearing age at the beginning of the study Exclusion Criteria: Patients with known severe (World Health Organization (WHO) stage III, sitting DBP stable at greater than or equal to 110 mmHg), malignant or secondary hypertension Patients who have had a myocardial infarction or percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) within the last 6 months Patients with a history or current evidence of congestive heart failure Bilateral renal artery stenosis Severe renal insufficiency (serum creatinine greater than 200 micro mol/l) Severe hepatic impairment or biliary obstruction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>2 week placebo run-in | Other: placebo<br>* Placebo oral tablets for 2 weeks<br>|
| Experimental: 2<br>Olmesartan medoxomil tablets for 8 weeks | Drug: olmesartan medoxomil<br>* olmesartan medoxomil oral tablets for 8 weeks<br>|
| Experimental: 3<br>Olmesartan medoxomil tablets, or olmesartan medoxomil tablets + hydrochlorothiazide tablets for 4 weeks | Drug: olmesartan medoxomil oral tablets, hydrochlorothiazide oral tablets<br>* olmesartan medoxomil oral tablets,or olmesartan medoxomil oral tablets + hydrochlorothiazide oral tablets<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the efficacy on diastolic blood pressure of 40 mg olmesartan to a combination of 20 mg olmesartan and 12.5 mg hydrochlorothiazide in patients who are not sufficiently responding to treatment with 20 mg olmesartan. |  | From week 8 to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effects on systolic and diastolic blood pressure of 20 mg olmesartan, 40 mg olmesartan and the combination of 20 mg olmesartan with 12.5 mg hydrochlorothiazide at week 2, 4, 8 and 12. |  | 12 weeks | 
| To detect less frequent adverse drug reactions and assess the safety and tolerability of olmesartan. |  | 12 weeks |