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Completed

NCT Number: NCT00751829

Isolated Systolic Hypertension in the Elderly and Very Elderly

To evaluate the efficacy of long-term treatment of individually optimized doses of olmesartan medoxomil compared to nitrendipine in elderly and very elderly patients with isolated systolic hypertension. The study hypothesis is non-inferiority of olmesartan medoxomil compared to nitrendipine in lowering mean sitting systolic blood pressure after 12 weeks of treatment compared to baseline. The study duration is up to 32 weeks, including a 24-week treatment period. After 12 weeks hydrochlorothiazide may be added to control blood pressure. Efficacy and safety measurements are carried out at up to 15 visits during the trial period.

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Key information

Conditions

Isolated Systolic Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Vascular Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Munich, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 65 or older
  • Mean sitting BP >160 mmHg and mean sitting dBP<90 mmHg

Exclusion criteria

  • Secondary hypertension
  • Malignant hypertension
  • Severe Heart Failure (NYHA III-IV)
  • Recent history of myocardial infarction
  • Hypersensitivity to study medications
  • History of drug or alcohol abuse
  • History or evidence of renal disease

Treatment and study plan

olmesartan medoxomil + hydrochlorothiazide, if necessary

Drug

oral olmesartan medoxomil tablets 20 mg or 40 mg once daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP

nitrendipine + hydrochlorothiazide, if necessary

Drug

oral nitrendipine tablets 10 or 20 mg taken twice daily for 24 weeks + oral hydrochlorothiazide tablets 12.5 or 25 mg once daily after 12 weeks, if needed to control BP

Primary outcomes

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

    Time frame: 12 weeks

Secondary outcomes

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

    Time frame: After 1, 2, 4, 8, 12, 16, 20, and 24 weeks

  2. Change in mean standing systolic BP, mean sitting diastolic BP and mean standing diastolic BP

    Time frame: after 1, 2, 4, 8, 12, 16, 20, and 24 weeks of treatment

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 Nitrendipine on Systolic Blood Pressure in Elderly and Very Elderly Patients With Isolated Systolic Hypertension

Important dates

Study start
2003
Primary completion
2004
Study completion
2005
First posted
Sep 12, 2008
Registry last updated
Jun 1, 2023

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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