Olmesartan Medoxomil Versus Losartan Potassium in Patient... | NCT00856271

Studies
Olmesartan Medoxomil Versus Losartan Potassium in Patients With Mild to Moderate Essential Hypertension

NCT00856271

Sponsor

Daiichi Sankyo

Status

Completed

Last Update Posted

Sep 29, 2010Estimated

Enrollment

287Actual

Phase

Phase 3

Conditions

Essential Hypertension

Interventions

olmesartan medoxomil
losartan potassium

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

Feb 2005Actual

Completion Date

Apr 2005Actual

First Submitted Date

Mar 3, 2009

First Submission Date that Met QC Criteria

Mar 4, 2009

First Posted Date

Mar 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 28, 2010

Last Update Posted Date

Sep 29, 2010Estimated

Name	Class
Shanghai Sankyo Pharmaceuticals Co., Ltd.	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of olmesartan medoxomil compared with losartan potassium in patients with mild to moderate essential hypertension.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

287Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	olmesartan medoxomil	Drug: olmesartan medoxomil
2	Active Comparator	losartan potassium	Drug: losartan potassium

Interventions

Name	Type	Description	Arm Group Labels	Other Names
olmesartan medoxomil	Drug	oral tablets, once daily for 8 weeks	1
losartan potassium

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of trough seated diastolic blood pressure from baseline to 8 weeks		Baseline to 8 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

mild to moderated essential hypertension (mean seated diastolic blood pressure ≥ 95 mmHg and <110 mmHg, mean seated systolic blood pressure < 180 mmHg)
able to give written informed consent

Exclusion Criteria:

known or suspected secondary hypertension
history of chronic hepatic diseases
obstructive hypertrophic cardiomyopathy/clinically significant valvular heart disease
cardiac arrhythmia
unstable angina pectoris
congestive heart insufficiency (New York Heart Association classification III-IV)
bilateral renal artery stenosis
isolated renal artery stenosis
post renal transplantation
history of acute myocardial infarction/percutaneous transluminal coronary angioplasty or heart surgery within three months before enrollment
retina bleeding/effusion
insulin dependent diabetes mellitus
uncontrolled non-insulin dependent diabetes mellitus

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Vice President	Sankyo Shanghai Pharmaceuticals	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension

Ancestor Terms

ID	Term
D006973	Hypertension
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068557	Olmesartan Medoxomil
D019808	Losartan

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing			China