PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)
A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined With Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets With Losartan Combined With Hydrochlorothiazide (50 mg/12.5 mg) Tablets Using Ambulatory Blood Pressure Monitoring in Patients With Mild-to-Moderate Hypertension
1 other identifier
interventional
805
1 country
69
Brief Summary
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
69 active sites
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
July 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2003
CompletedFirst Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedDecember 9, 2013
December 1, 2013
1 year
January 10, 2006
December 6, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring)
after 6 Weeks
Secondary Outcomes (6)
Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP)
after 6 weeks
Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP
after 6 weeks
Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval
after 6 weeks
Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval
after 6 weeks
Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer
after 6 weeks
- +1 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent in accordance with GCP and local legislation.
- Mild-to-moderate hypertension defined as a mean seated DBP of \>= 95 mm Hg and \<=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
- Male or Female \>= 18 years.
- Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
- hour ABPM mean DBP of \>= 85 mm Hg at Visit 3.
You may not qualify if:
- Pre-menopausal women (last menstruation \<= 1 year prior to signing informed consent) who
- are not surgically sterile, or are
- nursing, or
- are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do not plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. No exception will be made.
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- Mean seated SBP \>= 180 mm Hg or mean seated DBP \>= 110 mm Hg during any visit or the placebo run-in phase.
- Known or suspected secondary hypertension (i.e. pheochromocytoma).
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (\>203 mico mol/l).
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
- Biliary obstructive disorders.
- Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Congestive heart failure (NYHA functional class CHF III-IV).
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
Boehringer Ingelheim Investigational Site
Huntsville, Alabama, United States
Research Solutions, LLC
Little Rock, Arkansas, United States
Boehringer Ingelheim Investigational Site
Carmichael, California, United States
Boehringer Ingelheim Investigational Site
Concord, California, United States
Sierra Medical Research
Fresno, California, United States
Attn: Ginger Paselk
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
Orange, California, United States
DeBruin Medical Center
Orangevale, California, United States
Clinical Trials Research
Roseville, California, United States
Dr. R. David Ferrera
Sacramento, California, United States
Westlake Medical Research
Westlake Village, California, United States
Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
Wheat Ridge, Colorado, United States
Clinical Research Consultants, Inc.
Trumbull, Connecticut, United States
Glasgow Family Pract6ice
Newark, Delaware, United States
Boehringer Ingelheim Investigational Site
Coral Gables, Florida, United States
Miami Research Associates
Coral Gables, Florida, United States
Patron, Andres, D.O.
Hollywood, Florida, United States
Christopher Chappel, MD
Kissimmee, Florida, United States
Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Attention: Larry I. Gilderman, D.O.
Pembroke Pines, Florida, United States
nTouch Research
St. Petersburg, Florida, United States
Tampa Medical Research Associates
Tampa, Florida, United States
Southern Clinical Research and Management, Inc.
Augusta, Georgia, United States
Boehringer Ingelheim Investigational Site
Conyers, Georgia, United States
Treasure Valley Cardiology
Boise, Idaho, United States
Cedar-Crosse Research Center
Chicago, Illinois, United States
Herron Medical Center, Ltd.
Chicago, Illinois, United States
Protococare Trials, Inc.
Elk Grove Village, Illinois, United States
N Touch Research
Peoria, Illinois, United States
Midwest Institute for Clinical Research Inc.
Indianapolis, Indiana, United States
Radiant Research
Overland, Kansas, United States
Ong Medical Center
Oxon Hill, Maryland, United States
Radiant Research
Edina, Minnesota, United States
Cardiology Research
Saint Paul, Minnesota, United States
Attention: Mel E. Lucas, DO
Florissant, Missouri, United States
New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
Albuquerque, New Mexico, United States
Syracuse Preventative Cardiology
Syracuse, New York, United States
Great Lakes Medical Research
Westfield, New York, United States
Cardiology and Internal Medicine- Williamsville NY
Williamsville, New York, United States
Comprehensive Clinical Research
Bina, North Carolina, United States
Bennett Cardiac Center
Charlotte, North Carolina, United States
Charlotte Clinical Research
Charlotte, North Carolina, United States
Boehringer Ingelheim Investigational Site
Raleigh, North Carolina, United States
nTouch Research Corporation
Raleigh, North Carolina, United States
Piedmont Research Associates
Winston-Salem, North Carolina, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
Radiant Reseach
Cincinnati, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
nTouch
Oklahoma City, Oklahoma, United States
Hillcrest Medical Center
Tulsa, Oklahoma, United States
Bock Clinical Research
Collegeville, Pennsylvania, United States
Bock Clinical Research
Downingtown, Pennsylvania, United States
Bock Clinical Research
Harleysville, Pennsylvania, United States
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, United States
Omega Research
Warwick, Rhode Island, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Veterans Affairs Medical Center
Memphis, Tennessee, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, United States
Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
nTouch Research
Houston, Texas, United States
Hampton Roads Medical Specialists
Hampton, Virginia, United States
885 Kempsville Road, Suite 221
Norfolk, Virginia, United States
York Clinical Research
Norfolk, Virginia, United States
Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
Gemini Scientific
Madison, Wisconsin, United States
University of Wisconsin Medical School
Madison, Wisconsin, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Boehringer Ingelheim Study Coordinator
Boehringer Ingelheim
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 11, 2006
Study Start
July 1, 2002
Primary Completion
July 1, 2003
Last Updated
December 9, 2013
Record last verified: 2013-12