PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN

Condition(s) targeted: Hypertension

Intervention: Telmisartan (Drug); Ramipril (Drug)

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

Demonstrate that telmisartan 80mg was at least as effective and possibly superior to ramipril 5mg & 10mg in lowering mean ambulatory DBP and SBP during the last 6 hrs of the 24-hr dosing interval in mild-to-moderate hypertensives at the end of 8 and 14 week treatment phases.

Official title: A Prospective Randomized Open-Label Blinded-Endpoint (PROBE) Trial Comparing MICARDIS (Telmisartan) (40-80-80 mg QD) and Ramipril (2.5-5-10 mg QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)

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

Primary outcome: Change from baseline in the last 6-hr mean DBP & SBP as measured by ABPM at the end of and 8-wk treatment period (T80 vs R5 mg) and 14-wk treatment period (T80 vs R10 mg)

Secondary outcome: Change from baseline in last 6-hr ABPM mean for: pulse pressure; DBP, SBP and PP; DBP/SBP/PP in the morning, daytie and nighttime periods of the 24-hr dosing interval; Change from baseline in mean, seated, trough DBP & SBP measured by manual cuff

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

Boehringer Ingelheim Investigational Site, Birmingham, Alabama, United States

Boehringer Ingelheim Investigational Site, Red Deer, Alberta, Canada

Boehringer Ingelheim Investigational Site, Calgary, Alberta, Canada

Boehringer Ingelheim Investigational Site, Tuscon, Arizona, United States

Boehringer Ingelheim Investigational Site, Phoenix, Arizona, United States

Harold B. Betton, M.D., Little Rock, Arkansas, United States

Boehringer Ingelheim Investigational Site, Conquitlam, British Columbia, Canada

Boehringer Ingelheim Investigational Site, Santa Rosa, California, United States

Boehringer Ingelheim Investigational Site, Los Angeles, California, United States

Boehringer Ingelheim Investigational Site, Vista, California, United States

Boehringer Ingelheim Investigational Site, San Diego, California, United States

Boehringer Ingelheim Investigational Site, Santa Ana, California, United States

Boehringer Ingelheim Investigational Site, Orange, California, United States

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

Boehringer Ingelheim Investigational Site, Hamden, Connecticut, United States

Boehringer Ingelheim Investigational Site, Melbourne, Florida, United States

Boehringer Ingelheim Investigational Site, Ft. Lauderdale, Florida, United States

Boehringer Ingelheim Investigational Site, Daytona Beach, Florida, United States

Boehringer Ingelheim Investigational Site, Marietta, Georgia, United States

Boehringer Ingelheim Investigational Site, Meridian, Idaho, United States

Boehringer Ingelheim Investigational Site, Boise, Idaho, United States

Boehringer Ingelheim Investigational Site, Orland Park, Illinois, United States

Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States

GFI Pharmaceuticals, Evansville, Indiana, United States

Boehringer Ingelheim Investigational Site, Newton, Kansas, United States

Boehringer Ingelheim Investigational Site, Wichita, Kansas, United States

Boehringer Ingelheim Investigational Site, Metarie, Louisiana, United States

Boehringer Ingelheim Investigational Site, Auburn, Maine, United States

Boehringer Ingelheim Investigational Site, St. John, New Brunswick, Canada

Boehringer Ingelheim Investigational Site, Riverview, New Brunswick, Canada

Boehringer Ingelheim Investigational Site, Moorestown, New Jersey, United States

Boehringer Ingelheim Investigational Site, Albuquerque, New Mexico, United States

Boehringer Ingelheim Investigational Site, White Plains, New York, United States

Boehringer Ingelheim Investigational Site, East Syracuse, New York, United States

Boehringer Ingelheim Investigational Site, Mount Pearl, Newfoundland and Labrador, Canada

Boehringer Ingelheim Investigational Site, Bay Roberts, Newfoundland and Labrador, Canada

Boehringer Ingelheim Investigational Site, St. John's, Newfoundland and Labrador, Canada

Boehringer Ingelheim Investigational Site, Charlotte, North Carolina, United States

Boehringer Ingelheim Investigational Site, Winston Salem, North Carolina, United States

Boehringer Ingelheim Investigational Site, Halifax, Nova Scotia, Canada

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

Boehringer Ingelheim Investigational Site, Thunder Bay, Ontario, Canada

Boehringer Ingelheim Investigational Site, Oakville, Ontario, Canada

155 Ontario Street, St. Catharines, Ontario, Canada

Boehringer Ingelheim Investigational Site, Windsor, Ontario, Canada

205-13085 Yonge St, Richmond Hill, Ontario, Canada

Boehringer Ingelheim Investigational Site, Exeter, Ontario, Canada

Boehringer Ingelheim Investigational Site, Kitchener, Ontario, Canada

Boehringer Ingelheim Investigational Site, Hastings, Ontario, Canada

Boehringer Ingelheim Investigational Site, London, Ontario, Canada

Boehringer Ingelheim Investigational Site, Winnipeg, Ontario, Canada

Boehringer Ingelheim Investigational Site, North York, Ontario, Canada

Boehringer Ingelheim Investigational Site, Orleans, Ontario, Canada

Boehringer Ingelheim Investigational Site, Toronto, Ontario, Canada

Boehringer Ingelheim Investigational Site, Weston, Ontario, Canada

Boehringer Ingelheim Investigational Site, Portland, Oregon, United States

Boehringer Ingelheim Investigational Site, Levittown, Pennsylvania, United States

Boehringer Ingelheim Investigational Site, Charlottetown, Prince Edward Island, Canada

4 rue Robinson Nord, Granby, Quebec, Canada

Boehringer Ingelheim Investigational Site, Pointe Claire, Quebec, Canada

Boehringer Ingelheim Investigational Site, Longueuil, Quebec, Canada

725 6E Rue, Val D'Or, Quebec, Canada

Boehringer Ingelheim Investigational Site, St Leonard, Quebec, Canada

Boehringer Ingelheim Investigational Site, Saskatoon, Saskatchewan, Canada

Boehringer Ingelheim Investigational Site, Regina, Saskatchewan, Canada

Spartanburg Medical Research, Spartanburg, South Carolina, United States

Boehringer Ingelheim Investigational Site, Anderson, South Carolina, United States

R/D Clinical Research, Inc., Lake Jackson, Texas, United States

Boehringer Ingelheim Investigational Site, Dallas, Texas, United States

Boehringer Ingelheim Investigational Site, Salt Lake City, Utah, United States

Boehringer Ingelheim Investigational Site, Tacoma, Washington, United States

Boehringer Ingelheim Investigational Site, Lacey, Washington, United States

Boehringer Ingelheim Investigational Site, Lakewood, Washington, United States

Boehringer Ingelheim Investigational Site, Charleston, West Virginia, United States

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