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

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00274599
First received: January 10, 2006
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Telmisartan
Drug: Ramipril
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group, Multicentre, Forced-Titration, 14-Week Treatment Study Comparing MICARDIS® (Telmisartan 40-80-80 mg, QD) and ALTACE® (Ramipril 2.5-5-10 mg, QD) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

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

Enrollment: 812
Study Start Date: October 2002
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00274599

  Hide Study Locations
Locations
United States, Alabama
Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
United States, Arizona
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Tuscon, Arizona, United States
United States, Arkansas
Harold B. Betton, M.D.
Little Rock, Arkansas, United States
United States, California
Attn: Ginger Paselk
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
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Orange, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Santa Rosa, California, United States
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Vista, California, United States
United States, Connecticut
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Hamden, Connecticut, United States
United States, Florida
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Daytona Beach, Florida, United States
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Ft. Lauderdale, Florida, United States
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Melbourne, Florida, United States
United States, Georgia
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Marietta, Georgia, United States
United States, Idaho
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Boise, Idaho, United States
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Meridian, Idaho, United States
United States, Illinois
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Chicago, Illinois, United States
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Orland Park, Illinois, United States
United States, Indiana
GFI Pharmaceuticals
Evansville, Indiana, United States
United States, Kansas
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Newton, Kansas, United States
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Wichita, Kansas, United States
United States, Louisiana
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Metarie, Louisiana, United States
United States, Maine
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Auburn, Maine, United States
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Moorestown, New Jersey, United States
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Albuquerque, New Mexico, United States
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East Syracuse, New York, United States
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White Plains, New York, United States
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Charlotte, North Carolina, United States
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Winston Salem, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
United States, Pennsylvania
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Levittown, Pennsylvania, United States
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Anderson, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
United States, Texas
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Dallas, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
United States, Utah
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Salt Lake City, Utah, United States
United States, Washington
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Lacey, Washington, United States
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Lakewood, Washington, United States
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Tacoma, Washington, United States
United States, West Virginia
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Charleston, West Virginia, United States
Canada, Alberta
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Calgary, Alberta, Canada
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Red Deer, Alberta, Canada
Canada, British Columbia
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Conquitlam, British Columbia, Canada
Canada, New Brunswick
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Riverview, New Brunswick, Canada
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St. John, New Brunswick, Canada
Canada, Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada
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Mount Pearl, Newfoundland and Labrador, Canada
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St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
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Halifax, Nova Scotia, Canada
Canada, Ontario
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Exeter, Ontario, Canada
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Hastings, Ontario, Canada
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Kitchener, Ontario, Canada
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London, Ontario, Canada
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North York, Ontario, Canada
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Oakville, Ontario, Canada
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Orleans, Ontario, Canada
205-13085 Yonge St
Richmond Hill, Ontario, Canada
155 Ontario Street
St. Catharines, Ontario, Canada
Boehringer Ingelheim Investigational Site
Thunder Bay, Ontario, Canada
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Toronto, Ontario, Canada
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Weston, Ontario, Canada
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Windsor, Ontario, Canada
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Winnipeg, Ontario, Canada
Canada, Prince Edward Island
Boehringer Ingelheim Investigational Site
Charlottetown, Prince Edward Island, Canada
Canada, Quebec
4 rue Robinson Nord
Granby, Quebec, Canada
Boehringer Ingelheim Investigational Site
Longueuil, Quebec, Canada
Boehringer Ingelheim Investigational Site
Pointe Claire, Quebec, Canada
Boehringer Ingelheim Investigational Site
St Leonard, Quebec, Canada
725 6E Rue
Val D'Or, Quebec, Canada
Canada, Saskatchewan
Boehringer Ingelheim Investigational Site
Regina, Saskatchewan, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Study Coordinator Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00274599     History of Changes
Other Study ID Numbers: 502.392
Study First Received: January 10, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Cardiovascular Diseases
Vascular Diseases
Ramipril
Telmisartan
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Angiotensin-Converting Enzyme Inhibitors
Antihypertensive Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014