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

March 5, 2009
July 22, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • The difference from baseline in sitting trough dBP to week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The difference from baseline in sitting trough sBP to week 4 [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The difference from baseline in sitting trough sBP to week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • The difference from baseline in sitting trough sBP to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The difference from baseline in mean 24-hour sBP to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • The difference from baseline in mean 24-hour dBP to week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Comparison of the number of responders at 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Comparison of the number of responders at 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Comparison of the number of responders at 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Both
20 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00857285
TSP-866/01
No
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