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OpenTrials
Completed

NCT Number: NCT00857285

Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

The purpose of this study is to determine the efficacy and safety of oral administration of olmesartan medoxomil compared to losartan in subjects with mild to moderate hypertension.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diastolic BP 95 mm Hg - 114 mm Hg inclusive
  • No participation in any clinical trial for the last 3 months

Exclusion criteria

  • Secondary hypertension
  • Malignant hypertension
  • Severe arterial hypertension
  • Significant cardiovascular disease
  • History or clinical evidence of cerebrovascular, gastrointestinal, hematological, hepatic disease, myocardial infarction, or severe liver disorder
  • Clinical evidence of renal disease, poorly controlled diabetes, known malabsorption syndromes, psychiatric/emotional problems

Treatment and study plan

olmesartan medoxomil

Drug

olmesartan medoxomil oral tablets, once daily for up to 12 weeks

Losartan Potassium

Drug

losartan oral tablets, once daily for up to 12 weeks

Primary outcomes

  1. Mean Change of Sitting dBP From Baseline to Week 12

    Time frame: Baseline to 12 weeks

    The difference in the sitting diastolic blood pressure (dBP) at trough, i.e. 24±2 hours after drug administration, from base line to Week 12.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Daiichi Sankyo Taiwan Ltd.

Registry information

Official study title

A Multi-center, Double Blind, Efficacy, and Safety Study of the Oral Angiotensin II Receptor Blocker "Olmesartan Medoxomil" Versus "Losartan" in Patients With Mild to Moderate Essential Hypertension

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 6, 2009
Registry last updated
Jul 23, 2009

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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