Treatment of High Blood Pressure Using Olmesartan With Hy... | NCT00185120 | Trialant

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Treatment of High Blood Pressure Using Olmesartan With Hy... | NCT00185120 | Trialant

Studies
Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

NCT00185120

Sponsor

Daiichi Sankyo

Status

Completed

Last Update Posted

Jan 18, 2012Estimated

Enrollment

152

Phase

Phase 4

Conditions

Hypertension

Interventions

Olmesartan medoxomil
Hydroclorothiazide
Benazepril
Amlodipine

Countries

United States

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

NCT00185120

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

866-447

Secondary IDs

Not provided

Brief Title

Treatment of High Blood Pressure Using Olmesartan With Hydrochlorothiazide Compared to an ACE Inhibitor With a Calcium Channel Blocker

Official Title

A Study on the Efficacy and Safety of Olmesartan Medoxomil and Its Combination With Hydrochlorothiazide Compared With an ACE Inhibitor and Its Combination With a Calcium Channel Blocker in Patients With Stage 2 Hypertension

Acronym

Not provided

Organization

Daiichi SankyoINDUSTRY

Status Module

Record Verification Date

Jan 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Sep 2005

Primary Completion Date

Sep 2006Actual

Completion Date

Sep 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 16, 2005Estimated

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

Jan 16, 2012

Last Update Posted Date

Jan 18, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Daiichi SankyoINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

A comparison of 2 different combinations of high blood pressure medications to treat hypertension

Detailed Description

Not provided

Conditions Module

Conditions

Hypertension

Keywords

Hypertension
angiotensin receptor blocker
calcium channel blocker
angiotensin converting enzyme inhibitor hydroclorothiazide

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

152

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Olmesartan medoxomil	Drug
Hydroclorothiazide	Drug
Benazepril	Drug
Amlodipine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in systolic blood pressure from the start of the study

Secondary Outcomes

Measure	Description	Time Frame
Change in diastolic blood pressure from the start of the study
Percent of patients who achieve target blood pressure goals

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Greater than 18 years of age
Patients with high blood pressure

Exclusion Criteria:

Hypertensive encephalopathy, stroke or transient ischemic attack within the past 6 months
History of myocardial infarction, percutaneous transluminal coronary revascularization, coronary artery bypass graft, and/or unstable angina pectoris within the past 6 months
Type 1 diabetes mellitus

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Mobile	Alabama	36693	United States
Memorial Research Medical Center

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

Not provided

Long Beach

California

90806

United States

National Research Institute

Los Angeles

California

90057

United States

Clinical Trials Research

Roseville

California

95661

United States

Apex Research Institute

Santa Ana

California

92705

United States

Orange County Research Center

Tustin

California

92780

United States

Westlake Medical Center

Westlake Village

California

91361

United States

Clinical Research of South Florida

Coral Gables

Florida

33134

United States

The Greater Fort Lauderdale Heart Group Research

Fort Lauderdale

Florida

33308

United States

SFBC International

Miami

Florida

33142

United States

CLIRECO, Inc.

Tamarac

Florida

33321

United States

Midwest Institute for Clinical Research

Indianapolis

Indiana

46260

United States

Heartland Research Associates

Wichita

Kansas

67207

United States

Androscoggin Cardiology Research

Auburn

Maine

04210

United States

Internal Medicine Associates of Charlotte

Charlotte

North Carolina

28211

United States

Piedmont Medical Research Associates

Winston-Salem

North Carolina

27103

United States

The Lindner Clinical Trial Center

Cincinnati

Ohio

45319

United States

Omega Medical Research

Warwick

Rhode Island

02886

United States

Volunteer Research Group, University of Tennessee Med. Ctr.

Knoxville

Tennessee

37920

United States

Punzi Medical Center

Carrollton

Texas

75006

United States

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D000068557	Olmesartan Medoxomil
C044946	benazepril
D017311	Amlodipine

Ancestor Terms

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D013777	Tetrazoles
D004095	Dihydropyridines
D011725	Pyridines

Browse Leaves

Not provided

Browse Branches

Not provided