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Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857285
First Posted: March 6, 2009
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc.
March 5, 2009
March 6, 2009
May 28, 2009
July 23, 2009
July 29, 2009
May 2002
August 2003   (Final data collection date for primary outcome measure)
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. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00857285 on ClinicalTrials.gov Archive Site
Not Provided
  • The difference from baseline in sitting trough dBP to week 4 [ Time Frame: 4 weeks ]
  • The difference from baseline in sitting trough dBP to week 8 [ Time Frame: 8 weeks ]
  • The difference from baseline in sitting trough sBP to week 4 [ Time Frame: 4 weeks ]
  • The difference from baseline in sitting trough sBP to week 8 [ Time Frame: 8 weeks ]
  • The difference from baseline in sitting trough sBP to week 12 [ Time Frame: 12 weeks ]
  • The difference from baseline in mean 24-hour sBP to week 12 [ Time Frame: 12 weeks ]
  • The difference from baseline in mean 24-hour dBP to week 12 [ Time Frame: 12 weeks ]
  • Comparison of the number of responders at 4 weeks [ Time Frame: 4 weeks ]
  • Comparison of the number of responders at 8 weeks [ Time Frame: 8 weeks ]
  • Comparison of the number of responders at 12 weeks [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
Olmesartan Medoxomil Versus Losartan in Patients With Hypertension
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • Drug: olmesartan medoxomil
    olmesartan medoxomil oral tablets, once daily for up to 12 weeks
  • Drug: losartan potassium
    losartan oral tablets, once daily for up to 12 weeks
  • Experimental: 1
    olmesartan medoxomil
    Intervention: Drug: olmesartan medoxomil
  • Active Comparator: 2
    losartan potassium
    Intervention: Drug: losartan potassium
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
130
September 2003
August 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
20 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT00857285
TSP-866/01
No
Not Provided
Not Provided
Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd.
Daiichi Sankyo, Inc.
Daiichi Sankyo Taiwan Ltd.
Not Provided
Daiichi Sankyo, Inc.
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP