Isolated Systolic Hypertension in the Elderly and Very Elderly

Study Overview
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Brief Summary
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To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.

Official Title
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Comparison of the Efficacy of Olmesartan Medoxomil Versus Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension

Conditions
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Isolated Systolic Hypertension

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 65 or older Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg Exclusion Criteria: Secondary hypertension Malignant hypertension Severe Heart Failure (NYHA III-IV) Recent history of myocardial infarction Hypersensitivity to study medications History of drug or alcohol abuse History or evidence of renal disease

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 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to controll BP | Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary<br>* oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP<br>|
| Active Comparator: 2<br>oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP | Drug: nitrendipine + hydrochlorothiazide, if necessary<br>* oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily 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 systolic blood pressure as assessed by conventional BP measurements |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean sitting systolic blood pressure assessed by conventional BP measurements |  | After 1, 2, 4, 8, 12, 16, 20, and 24 weeks | 
| Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP |  | after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment |