Olmesartan Medoxomil in Hypertension and Renal Impairment

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sankyo Pharma Gmbh
• Treatments: Furosemide; Losartan; Olmesartan; Olmesartan Medoxomil

Criteria

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