Olmesartan Medoxomil Versus Losartan in Patients With Hypertension

• Sponsor: Daiichi Sankyo, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00857285
• Collaborator: Daiichi Sankyo Taiwan Ltd. (Industry)
• Enrollment: 130
• Locations: 3
• Arms: 2
• Duration (Months): 16
• Patients Per Site: 43.3
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Essential Hypertension	Drug: olmesartan medoxomil; Drug: losartan potassium	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: May 1, 2002
• Actual Primary Completion Date: Aug 1, 2003
• Actual Study Completion Date: Sep 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Kaohsiung Medical University Hospital	Kaohsiung		Taiwan
2	Chung Shun Medical University Hospital	Taichung City		Taiwan
3	National Taiwan University Hospital	Taipei		Taiwan

Sponsors and Collaborators

• Daiichi Sankyo, Inc.
• Daiichi Sankyo Taiwan Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00857285
• Other Study ID Numbers: TSP-866/01
• First Posted: Mar 6, 2009
• Last Update Posted: Jul 23, 2009
• Last Verified: Jul 1, 2009

• Additional relevant MeSH terms: Hypertension; Essential Hypertension; Losartan; Olmesartan; Olmesartan Medoxomil

Study Results

Participant Flow

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 Detail	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
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

Baseline Characteristics

Arm/Group Title	Olmesartan Medoxomil	Losartan Potassium	Total
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 Participants	65	65	130
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	49.63 (10.69)	48.34 (9.17)	48.98 (9.94)
Sex: Female, Male (Count of Participants)
Female	33 50.8%	23 35.4%	56 43.1%
Male	32 49.2%	42 64.6%	74 56.9%
Race/Ethnicity, Customized (participants) [Number]
Taiwanese	65 100%	65 100%	130 100%
Region of Enrollment (participants) [Number]
Taiwan	65 100%	65 100%	130 100%

Outcome Measures

1. Primary Outcome

Title	Mean Change of Sitting dBP From Baseline to Week 12
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

Outcome Measure Data

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
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
Measure Participants	62	64
Mean (Standard Error) [mmHg]	-14.80 (12.50)	-11.60 (9.46)

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

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.