Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

Overview

To assess the efficacy of individually optimized doses of olmesartan medoxomil compared to losartan in elderly and very elderly patients with essential hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to losartan in lowering mean sitting diastolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 60 weeks, including a 52-week treatment period. After 12 weeks of treatment hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 18 visits during the trial.

Full Title of Study: “Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: April 2005

Interventions

  • Drug: olmesartan medoxomil + hydrochlorothiazide, if necessary
    • oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP
  • Drug: losartan + hydrochlorothiazide, if necessary
    • oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tablets, after 12 weeks, if needed to control BP.

Arms, Groups and Cohorts

  • Experimental: 1
    • oral olmesartan medoxomil tablets 20 or 40 mg taken once daily for 52 weeks + hydrochlorothiazide tablets 12.5 or 25 mg , if needed to control BP after 12 weeks
  • Active Comparator: 2
    • oral losartan capsules, 50 or 100 mg taken once daily for 52 weeks + 12.5 or 25 mg oral hydrochlorothiazide tables, after 12 weeks, if needed to control BP.

Clinical Trial Outcome Measures

Primary Measures

  • Change in mean sitting diastolic blood pressure assessed by conventional BP measurements
    • Time Frame: 12 weeks

Secondary Measures

  • Change in mean sitting diastolic BP assessed by conventional BP measurements
    • Time Frame: after 1, 2, 4, 8, 16, 20, 28, 36, 44, and 52 weeks
  • Change in mean standing diastolic BP, mean sitting systolic BP and mean standing systolic BP
    • Time Frame: after 1, 2, 4, 8, 12, 16, 20, 28, 36, 44, and 52 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Age 65 years or older – Mean sitting diastolic BP = 100-114 mmHg and mean sitting systolic BP >=150 mm HG Exclusion Criteria:

  • Secondary hypertension – Malignant hypertension – Severe heart failure (NYHA III-IV) – History or evidence of renal disease – Recent history of myocardial infarction – Hypersensitivity to study drugs – History of drug or alcohol abuse

Gender Eligibility: All

Minimum Age: 65 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
  • Provider of Information About this Clinical Study
    • Petra Laeis, Ph.D., Daiichi Sankyo Europe, GmbH
  • Overall Official(s)
    • Peter U Witte, MD, Ph.D., Principal Investigator, IMFORM GmbH

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