Olmesartan Medoxomil in Hypertension and Renal Impairment

Daiichi Sankyo

Status and phase: Completed; Phase 3

Conditions: Renal Impairment; Essential Hypertension

Treatments: Drug: Olmesartan medoxomil; Drug: Losartan; Drug: Furosemide oral tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00151827

SE-866/43

Details and patient eligibility

About

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

Enrollment: 393 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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393 participants in 2 patient groups

Olmesartan medoxomil

Experimental group

Description:

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

Treatment:

Drug: Olmesartan medoxomil

Drug: Furosemide oral tablets

Losartan

Experimental group

Description:

Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.

Treatment:

Drug: Losartan

Drug: Furosemide oral tablets