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NCT Number: NCT00751751

Olmesartan Medoxomil Versus Losartan in Elderly and Very Elderly

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.

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Darmstadt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olmesartan medoxomil + hydrochlorothiazide, if necessary

Drug

oral olmesartan medoxomil tablets taken once daily for 52 weeks + oral hydrochlorothiazide tablets, once daily, after 12 weeks if needed to control BP

losartan + hydrochlorothiazide, if necessary

Drug

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.

Primary outcomes

  1. Change in mean sitting diastolic blood pressure assessed by conventional BP measurements

    Time frame: 12 weeks

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company

Industry

Registry information

Official study title

Comparison of the Efficacy of Olmesartan Medoxomil Versus Losartan on Diastolic Blood Pressure in Elderly and Very Elderly Patients With Essential Hypertension.

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 12, 2008
Registry last updated
Sep 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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