Efficacy and Safety of Olmesartan Medoxomil in Stage 1 and 2 Essential Hypertension

Study Overview
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Brief Summary
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In patients naive to treatment or after a 2-week washout period for patients whose treatment was ineffective, the use of olmesartan was assessed in a 4-phase treatment scheme: monotherapy, addition of hydrochlorothiazide (2 phases), addition of amlodipine.

Official Title
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National, Multicenter, Open-Label and Prospective Study Assessment of Efficacy and Safety in Stage 1 and 2 Essential Hypertension With Olmesartan Medoxomil Based Treatment Algorithm From Monotherapy to Association With Hydrochlorothiazide and Amlodipine Besylate

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stage 1 and 2 hypertension without treatment for at least 2 weeks Women with no risk of becoming pregnant Exclusion Criteria: Study participation could result in risk to health of subject Cardiovascular disease Secondary hypertension or stage 3 hypertension Myocardial infarction within the last 6 months Congestive heart failure Pulmonary edema Valvular alterations or rheumatic cardiopathy Clinically relevant conduction disorders significant arrhythmias Alcohol or illicit drug use Medication abuse Pregnant or nursing women

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary + amlodipine, if necessary<br>* olmesartan medoxomil tablets,or olmesartan medoxomil/hydrochlorothiazide tablets, if necessary + amlodipine tablets, if necessary. All interventions are once-daily for 4 to 9 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 (Olmesartan 20 mg Monotherapy) | Number of patients that achieved a blood pressure (BP) goal of less than 130/85 in the first group (olmesartan monotherapy 20 mg). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level for an additional 4-9 weeks at the next medication level | 4 - 9 wks of olmesartan monotherapy | 
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in First Titrated Group (Olmesartan 20 mg + 12.5 mg Hydrochlorothiazide) | Number of patients that achieved a blood pressure goal of less than 130/85 in first titrated group (olmesartan 20 mg + 12.5 mg hydrochlorothiazide)If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks | 4 to 9 weeks on combination therapy | 
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Second Titrated Group (Olmesartan 40 mg + 25 mg Hydrochlorothiazide) | Number of patients that achieved a blood pressure goal of less than 130/85 in second titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide). If BP was > or = to 140/90 at 4,8, or 9 wks the participant went to next level of medication for an additional 4-9 weeks. | 4 to 9 weeks | 
| Number of Patients That Achieved a Blood Pressure Goal of Less Than 130/85 in Third Titrated Group (Olmesartan + Hydrochorothiazide + Amlodipine) | Number of patients that achieved a blood pressure goal of less than 130/85 in third titrated group (olmesartan 40 mg + 25 mg hydrochlorothiazide + amlodipine 5 mg). This combination was maintained as long as the participant's blood pressure remained within predefined parameters. If not, participant discontinued for lack of efficacy. | 4 - 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypertension, angiotensin II type 1 receptor blocker, olmesartan