Olmesartan Medoxomil in Hypertension and Renal Impairment

Sankyo Pharma Gmbh393 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

393

Conditions

Essential Hypertension Renal Impairment

Interventions

Olmesartan medoxomilDRUG

Olmesartan oral tablets 20 or 40 mg + losartan placebo. Medications are taken once daily before breakfast with water.

LosartanDRUG

Medications are taken once daily before breakfast with water.

Furosemide oral tabletsDRUG

If its use is necessary, the dose of furosemide allowed is 20 to 120 mg per day at the discretion of the investigator

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Unnamed facility

Darmstadt, Germany

Outcomes

Primary Outcomes

Change in mean sitting diastolic blood pressure (dBP), assessed by conventional blood pressure measurements after 12 weeks of treatment

Time frame: Baseline to 12 weeks

Secondary Outcomes

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;

Time frame: 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;

Time frame: 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

Time frame: 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;

Time frame: Baseline to 12 and 52 weeks

Changes in serum creatinine after 12 and 52 weeks of treatment

Time frame: Baseline to 12 and 52 weeks

Rate of patients per dose level after 12 and 52 weeks of treatment

Time frame: Baseline to 12 and 52 weeks

Change in proteinuria after 4, 12, 24, 36 and 52 weeks of treatment

Time frame: Baseline to 4, 12, 24, 36 and 52 weeks

Data from ClinicalTrials.gov

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