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Trial record 36 of 134 for:    OLMESARTAN

Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

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ClinicalTrials.gov Identifier: NCT00857285
Recruitment Status : Completed
First Posted : March 6, 2009
Results First Posted : July 23, 2009
Last Update Posted : July 23, 2009
Sponsor:
Collaborator:
Daiichi Sankyo Taiwan Ltd.
Information provided by:
Daiichi Sankyo, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Essential Hypertension
Interventions Drug: olmesartan medoxomil
Drug: losartan potassium
Enrollment 130
Recruitment Details A total of 181 subjects were screened at 3 study sites in Taiwan from May 2002 to April 2003, and 51 subjects had dropped as screen failure.
Pre-assignment Details After a taper off period for 1 week, if necessary, and a placebo run-in period for 2 weeks, 130 subjects were randomized to olmesartan 20mg and losartan 50mg by 1:1 ratio.
Arm/Group Title Olmesartan Medoxomil Losartan Potassium
Hide Arm/Group Description olmesartan medoxomil oral tablets, once daily for up to 12 weeks losartan potassium oral tablets, once daily for up to 12 weeks
Period Title: Overall Study
Started 65 65
Completed 53 59
Not Completed 12 6
Reason Not Completed
Adverse Event             4             2
Lack of Efficacy             0             2
Protocol Violation             3             1
Withdrawal by Subject             4             0
Randomization criteria not met             1             1
Arm/Group Title Olmesartan Medoxomil Losartan Potassium Total
Hide Arm/Group Description olmesartan medoxomil oral tablets, once daily for up to 12 weeks losartan potassium oral tablets, once daily for up to 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 65 65 130
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants 65 participants 130 participants
49.63  (10.69) 48.34  (9.17) 48.98  (9.94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants 65 participants 130 participants
Female
33
  50.8%
23
  35.4%
56
  43.1%
Male
32
  49.2%
42
  64.6%
74
  56.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Taiwanese Number Analyzed 65 participants 65 participants 130 participants
65 65 130
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 65 participants 65 participants 130 participants
65 65 130
1.Primary Outcome
Title Mean Change of Sitting dBP From Baseline to Week 12
Hide Description 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 Baseline to 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Four randomized subjects (3 in olmesartan, 1 in losartan) were excluded from the analysis due to a lack of post-treatment efficacy evaluation.
Arm/Group Title Olmesartan Medoxomil Losartan Potassium
Hide Arm/Group Description:
olmesartan medoxomil oral tablets, once daily for up to 12 weeks
losartan potassium oral tablets, once daily for up to 12 weeks
Overall Number of Participants Analyzed 62 64
Mean (Standard Error)
Unit of Measure: mmHg
-14.80  (12.50) -11.60  (9.46)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director, Regulatory Operations
Organization: Daiichi Sankyo, Inc.
Phone: 732-590-5000
EMail: hmkessler@dsus.com
Layout table for additonal information
Responsible Party: Ammy Chou, Director, Daiichi Sankyo Taiwan Ltd.
ClinicalTrials.gov Identifier: NCT00857285     History of Changes
Other Study ID Numbers: TSP-866/01
First Submitted: March 5, 2009
First Posted: March 6, 2009
Results First Submitted: May 28, 2009
Results First Posted: July 23, 2009
Last Update Posted: July 23, 2009