Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00857285
First received: March 5, 2009
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention Phase
Essential Hypertension
Drug: olmesartan medoxomil
Drug: losartan potassium
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Daiichi Sankyo Inc.:

Primary Outcome Measures:
  • Mean Change of Sitting dBP From Baseline to Week 12 [ Time Frame: Baseline to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 130
Study Start Date: May 2002
Study Completion Date: September 2003
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
olmesartan medoxomil
Drug: olmesartan medoxomil
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
Active Comparator: 2
losartan potassium
Drug: losartan potassium
losartan oral tablets, once daily for up to 12 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857285

Locations
Taiwan
Kaohsiung Medical University Hospital
Kaohsiung, Taiwan
Chung Shun Medical University Hospital
Taichung City, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
Daiichi Sankyo Inc.
Daiichi Sankyo Taiwan Ltd.
  More Information

No publications provided

Responsible Party: Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd.
ClinicalTrials.gov Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
Study First Received: March 5, 2009
Results First Received: May 28, 2009
Last Updated: July 22, 2009
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Losartan
Olmesartan
Olmesartan medoxomil
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014