Status:
COMPLETED
Olmesartan Medoxomil in Hypertension and Renal Impairment
Lead Sponsor:
Sankyo Pharma Gmbh
Conditions:
Essential Hypertension
Renal Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a study in hypertensive patients with mild to moderate renal impairment. The antihypertensive efficacy of olmesartan medoxomil is compared to losartan.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
393 Patients enrolled
Trial Details
Trial ID
NCT00151827
Start Date
August 1 2003
End Date
July 1 2005
Last Update
October 14 2010
Active Locations (1)
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1
Darmstadt, Germany