PROBE Parallel 6-wk Treatment Comparing Telmisartan/HCT (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using ABPM

Condition(s) targeted: Hypertension

Intervention: Telmisartan & Hydrochlorothiazide (Drug); Losartan & Hydrochlorothiazide (Drug); ABPM (Procedure)

Phase: Phase 4

Status: Completed

Sponsored by: Boehringer Ingelheim Pharmaceuticals

Official(s) and/or principal investigator(s):
Boehringer Ingelheim Study Coordinator, Study Chair, Affiliation: Boehringer Ingelheim Pharmaceuticals

To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-mod hypertensives

Official title: PROBE Parallel Group 6 wk Treatment Comparing Telmisartan + HCT (40/12.5mg, or 80/12.5mg) With Losartan + HCT (50/12.5mg) Using ABPM in Pts With Mild-to Moderate Hypertension

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Primary outcome: To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering DBP during the last 6 hrs of the 24-hr dosing interval in mild-mod hypertensives at the end of a 6-w

Secondary outcome: Compared MICARDIS® HCT with Hyzaar® at the end of 6 wks treatment in the reduction of SBP during the last 6 hrs of the 24-hr dosing interval; also in 24-hr ABPM mean DBP and SBP; reductions in ABPM mean DBP & SBP (morn, day & night); manual cuff reading

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Boehringer Ingelheim Investigational Site, Huntsville, Alabama, United States

Research Solutions, LLC, Little Rock, Arkansas, United States

Boehringer Ingelheim Investigational Site, Carmichael, California, United States

Attn: Ginger Paselk, Long Beach, California, United States

DeBruin Medical Center, Orangevale, California, United States

Dr. R. David Ferrera, Sacramento, California, United States

Boehringer Ingelheim Investigational Site, Concord, California, United States

Boehringer Ingelheim Investigational Site, Orange, California, United States

Westlake Medical Research, Westlake Village, California, United States

Clinical Trials Research, Roseville, California, United States

Sierra Medical Research, Fresno, 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

Christopher Chappel, MD, Kissimmee, Florida, United States

Miami Research Associates, Coral Gables, Florida, United States

Attention: Larry I. Gilderman, D.O., Pembroke Pines, Florida, United States

Tampa Medical Research Associates, Tampa, Florida, United States

Orlando Clinical Research Center, Orlando, Florida, United States

Patron, Andres, D.O., Hollywood, Florida, United States

Boehringer Ingelheim Investigational Site, Coral Gables, Florida, United States

nTouch Research, St. Petersburg, Florida, United States

Boehringer Ingelheim Investigational Site, Melbourne, 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

Protococare Trials, Inc., Elk Grove Village, Illinois, United States

N Touch Research, Peoria, Illinois, United States

Herron Medical Center, Ltd., Chicago, Illinois, United States

Cedar-Crosse Research Center, Chicago, 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

Cardiology Research, St. Paul, Minnesota, United States

Radiant Research, Edina, Minnesota, United States

Attention: Mel E. Lucas, DO, Florissant, Missouri, United States

New Mexico Clinical Reaearch & Osteoporosis Center, Inc., Alburquerque, New Mexico, United States

Great Lakes Medical Research, Westfield, New York, United States

Cardiology and Internal Medicine- Williamsville NY, Williamsville, New York, United States

Syracuse Preventative Cardiology, Syracuse, New York, United States

Bennett Cardiac Center, Charlotte, North Carolina, United States

Charlotte Clinical Research, Charlotte, North Carolina, United States

Comprehensive Clinical Research, Berlin, 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, Raleigh, North Carolina, United States

Boehringer Ingelheim Investigational Site, Cincinnati, Ohio, United States

Radiant Reseach, Cincinnati, Ohio, United States

Radiant Research, Columbus, Ohio, United States

nTouch, Oklahoma City, Oklahoma, United States

Boehringer Ingelheim Investigational Site, Oklahoma City, Oklahoma, United States

Hillcrest Medical Center, Tulsa, Oklahoma, United States

Bock Clinical Research, Harleysville, Pennsylvania, United States

Bock Clinical Research, Downingtown, Pennsylvania, United States

Bock Clinical Research, Collegeville, Pennsylvania, United States

The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, United States

Omega Research, Warwick, Rhode Island, United States

Veterans Affairs Medical Center, Memphis, Tennessee, United States

University of Tennessee Medical Center, Knoxville, 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

Boehringer Ingelheim Investigational Site, Richmond, Virginia, United States

York Clinical Research, Norfolk, Virginia, United States

885 Kempsville Road, Suite 221, Norfolk, Virginia, United States

Gemini Scientific, Madison, Wisconsin, United States

University of Wisconsin Medical School, Madison, Wisconsin, United States

Starting date: July 2002
Ending date: January 2004
Last updated: April 3, 2008