Olmesartan Medoxomil in Hypertension and Renal Impairment

Last updated: October 13, 2010
Sponsor: Sankyo Pharma Gmbh
Overall Status: Completed

Phase

3

Condition

High Blood Pressure (Hypertension)

Williams Syndrome

Kidney Disease

Treatment

N/A

Clinical Study ID

NCT00151827
SE-866/43
  • Ages 18-75
  • All Genders

Study 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

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

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 diseasewhich in the opinion of the investigator would interfere with the patient'sparticipation 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 withoutadequate contraception;

  • History of drug and/or alcohol abuse

Study Design

Total Participants: 393
Study Start date:
August 01, 2003
Estimated Completion Date:
July 31, 2005

Connect with a study center

  • Darmstadt,
    Germany

    Site Not Available

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