Olmesartan Medoxomil in Hypertension and Renal Impairment

Study Overview
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Brief Summary
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This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.

Official Title
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Efficacy and Safety of Olmesartan Medoxomil Compared With Losartan in Patients With Hypertension and Mild to Moderate Renal Impairment

Conditions
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Essential Hypertension, Renal Impairment

Intervention / Treatment
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* Drug: Olmesartan medoxomil
* Drug: Losartan
* Drug: Furosemide oral tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Mean sitting BP prior to randomization of 140-180/90-109 mmHg; Renal impairment prior to randomization of mild (50 ≤ CLcr ≥ 80 mL/min) to moderate (30 ≤ CLcr ≥50 mL/min) severity Exclusion Criteria: Malignant hypertension or sitting BP greater than 180/109 mmHg; Severe heart failure, severe renal disease; Recent history of myocardial infarction, stroke or transient ischemic attack; History, clinical or current evidence of any significant gastrointestinal, respiratory, hematological, metabolic, immunological or any other underlying disease which in the opinion of the investigator would interfere with the patient's participation in the trial; Hypersensitivity or contraindications to ARBs or ACE inhibitors or any cross allergy; Treatment with dis-allowed medication; Pregnant or breastfeeding females or females of childbearing potential without adequate contraception; History of drug and/or alcohol abuse

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 |
| --- | --- |
| Experimental: Olmesartan medoxomil<br>Olmesartan oral tablets 20 mg or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water. | Drug: Olmesartan medoxomil<br>* Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.<br>Drug: Furosemide oral tablets<br>* If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator<br>|
| Experimental: Losartan<br>Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo. | Drug: Losartan<br>* Medications are taken once daily before breakfast with water.<br>Drug: Furosemide oral tablets<br>* If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator<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 (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment |  | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean sitting diastolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment; |  | Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks | 
| Change in mean sitting systolic blood pressure, assessed by conventional blood pressure measurements after 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks of treatment; |  | Baseline to 1, 2, 3, 8, 18, 24, 30, 36, 44 and 52 weeks | 
| Response to treatment after 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks of treatment; | Response to treatment = mean sitting diastolic blood pressure less than or equal to 90 mmHg or reduction greater than or equal to 10 mmHg | Baseline to 1, 2, 4, 8, 12, 18, 24, 30, 36, 44 and 52 weeks | 
| Changes in creatinine clearance after 12 and 52 weeks of treatment, changes in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment; |  | Baseline to 12 and 52 weeks | 
| Changes in serum creatinine after 12 and 52 weeks of treatment |  | Baseline to 12 and 52 weeks | 
| Rate of patients per dose level after 12 and 52 weeks of treatment |  | Baseline to 12 and 52 weeks | 
| Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment |  | Baseline to 4, 12, 24, 36 and 52 weeks |