Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Study Overview
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Brief Summary
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To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.

Official Title
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Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.

Conditions
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Essential Hypertension

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 years or older Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG Exclusion Criteria: Secondary hypertension Malignant hypertension Severe heart failure (NYHA III-IV) History or evidence of renal disease Recent history of myocardial infarction Hypersensitivity to study drugs History of drug or alcohol abuse

Ages Eligible for Study
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Minimum Age: 65 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 |
| --- | --- |
| Experimental: 1<br>oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary<br>* oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP<br>|
| Active Comparator: 2<br>oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP. | Drug: losartan + hydrochlorothiazide, if necessary<br>* oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean sitting diastolic blood pressure assessed by conventional BP measurements |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean sitting diastolic BP assessed by conventional BP measurements |  | after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks | 
| Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP |  | after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks |