Olmesartan Medoxomil in Hypertension and Renal Impairment

S

Sankyo Pharma Gmbh

Status and phase

Completed
Phase 3

Conditions

Renal Impairment
Essential Hypertension

Treatments

Drug: Losartan
Drug: Olmesartan medoxomil
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

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: Furosemide oral tablets
Drug: Olmesartan medoxomil
Losartan
Experimental group
Description:
Losartan over encapsulated tablets 50 mg and 100 mg plus olmesartan placebo.
Treatment:
Drug: Furosemide oral tablets
Drug: Losartan

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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