NCT00185120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Sep 2005

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

January 18, 2012

Status Verified

January 1, 2012

Enrollment Period

1 year

First QC Date

September 9, 2005

Last Update Submit

January 16, 2012

Conditions

Keywords

Hypertensionangiotensin receptor blockercalcium channel blockerangiotensin converting enzyme inhibitor hydroclorothiazide

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure from the start of the study

Secondary Outcomes (2)

  • Change in diastolic blood pressure from the start of the study

  • Percent of patients who achieve target blood pressure goals

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Greater than 18 years of age
  • Patients with high blood pressure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Unknown Facility

Mobile, Alabama, 36693, United States

Location

Memorial Research Medical Center

Long Beach, California, 90806, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Clinical Trials Research

Roseville, California, 95661, United States

Location

Apex Research Institute

Santa Ana, California, 92705, United States

Location

Orange County Research Center

Tustin, California, 92780, United States

Location

Westlake Medical Center

Westlake Village, California, 91361, United States

Location

Clinical Research of South Florida

Coral Gables, Florida, 33134, United States

Location

The Greater Fort Lauderdale Heart Group Research

Fort Lauderdale, Florida, 33308, United States

Location

SFBC International

Miami, Florida, 33142, United States

Location

CLIRECO, Inc.

Tamarac, Florida, 33321, United States

Location

Midwest Institute for Clinical Research

Indianapolis, Indiana, 46260, United States

Location

Heartland Research Associates

Wichita, Kansas, 67207, United States

Location

Androscoggin Cardiology Research

Auburn, Maine, 04210, United States

Location

Internal Medicine Associates of Charlotte

Charlotte, North Carolina, 28211, United States

Location

Piedmont Medical Research Associates

Winston-Salem, North Carolina, 27103, United States

Location

The Lindner Clinical Trial Center

Cincinnati, Ohio, 45319, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Volunteer Research Group, University of Tennessee Med. Ctr.

Knoxville, Tennessee, 37920, United States

Location

Punzi Medical Center

Carrollton, Texas, 75006, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Olmesartan MedoxomilbenazeprilAmlodipine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDihydropyridinesPyridines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 16, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

January 18, 2012

Record last verified: 2012-01

Locations