PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN
NCT ID: NCT00274599
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
812 participants
INTERVENTIONAL
2002-10-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Telmisartan
Ramipril
Eligibility Criteria
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Inclusion Criteria
* Mild-to-moderate hypertension defined as a mean seated diastolic blood pressure of ≥95 mmHg and ≤109 mmHg, measured by manual cuff sphygmomanometer at Visit 2.
* Age 18 years or older (or 19 years if dictated by local State/Province policies).
* Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
* 24-hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM).
Exclusion Criteria
* were not surgically sterile; or
* were nursing, or
* were of childbearing potential and were NOT practicing acceptable methods of birth control, or did NOT plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control included IUD, oral, implantable or injectable contraceptives. No exceptions were made.
* Night shift workers who routinely slept during the daytime and whose work hours included midnight to 4:00 a.m.
* Mean seated SBP ≥180 mmHg or mean seated DBP ≥110 mmHg during any visit of the placebo run-in period.
* Known or suspected secondary hypertension (e.g., phaeochromocytoma).
* Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
* Serum Glutamate-Oxaloacetate-Transaminase (Aspartate Aminotransferase) (SGOT (AST)) or Serum Glutamate-Pyruvate-Transaminase (Alanine Aminotransferase) (SGPT (ALT)) \>2 times the upper limit of normal range, or
* Serum creatinine \>2.3 mg/dL (or \>203 μmol/l).
* Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
* Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
* Uncorrected volume depletion.
19 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim Study Coordinator
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
Boehringer Ingelheim Investigational Site
Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
Harold B. Betton, M.D.
Little Rock, Arkansas, United States
Attn: Ginger Paselk
Long Beach, California, United States
Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
Boehringer Ingelheim Investigational Site
Orange, 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
Santa Rosa, California, United States
Boehringer Ingelheim Investigational Site
Vista, California, United States
Boehringer Ingelheim Investigational Site
Hamden, Connecticut, United States
Boehringer Ingelheim Investigational Site
Daytona Beach, Florida, United States
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida, United States
Boehringer Ingelheim Investigational Site
Melbourne, Florida, United States
Boehringer Ingelheim Investigational Site
Marietta, Georgia, United States
Boehringer Ingelheim Investigational Site
Boise, Idaho, United States
Boehringer Ingelheim Investigational Site
Meridian, Idaho, United States
Boehringer Ingelheim Investigational Site
Chicago, Illinois, United States
Boehringer Ingelheim Investigational Site
Orland Park, 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
Metairie, Louisiana, United States
Boehringer Ingelheim Investigational Site
Auburn, Maine, United States
Boehringer Ingelheim Investigational Site
Moorestown, New Jersey, United States
Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico, United States
Boehringer Ingelheim Investigational Site
East Syracuse, New York, United States
Boehringer Ingelheim Investigational Site
White Plains, New York, United States
Boehringer Ingelheim Investigational Site
Charlotte, North Carolina, United States
Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina, United States
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma, United States
Boehringer Ingelheim Investigational Site
Portland, Oregon, United States
Boehringer Ingelheim Investigational Site
Levittown, Pennsylvania, United States
Boehringer Ingelheim Investigational Site
Anderson, South Carolina, United States
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Boehringer Ingelheim Investigational Site
Dallas, Texas, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States
Boehringer Ingelheim Investigational Site
Salt Lake City, Utah, United States
Boehringer Ingelheim Investigational Site
Lacey, Washington, United States
Boehringer Ingelheim Investigational Site
Lakewood, Washington, United States
Boehringer Ingelheim Investigational Site
Tacoma, Washington, United States
Boehringer Ingelheim Investigational Site
Charleston, West Virginia, United States
Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
Boehringer Ingelheim Investigational Site
Red Deer, Alberta, Canada
Boehringer Ingelheim Investigational Site
Conquitlam, British Columbia, Canada
Boehringer Ingelheim Investigational Site
Riverview, New Brunswick, Canada
Boehringer Ingelheim Investigational Site
Saint John, New Brunswick, Canada
Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador, Canada
Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada
Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador, Canada
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia, Canada
Boehringer Ingelheim Investigational Site
Exeter, Ontario, Canada
Boehringer Ingelheim Investigational Site
Hastings, Ontario, Canada
Boehringer Ingelheim Investigational Site
Kitchener, Ontario, Canada
Boehringer Ingelheim Investigational Site
London, Ontario, Canada
Boehringer Ingelheim Investigational Site
North York, Ontario, Canada
Boehringer Ingelheim Investigational Site
Oakville, Ontario, Canada
Boehringer Ingelheim Investigational Site
Orléans, 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
Boehringer Ingelheim Investigational Site
Toronto, Ontario, Canada
Boehringer Ingelheim Investigational Site
Weston, Ontario, Canada
Boehringer Ingelheim Investigational Site
Windsor, Ontario, Canada
Boehringer Ingelheim Investigational Site
Winnipeg, Ontario, Canada
Boehringer Ingelheim Investigational Site
Charlottetown, Prince Edward Island, Canada
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
Saint-Léonard, Quebec, Canada
725 6E Rue
Val-d'Or, Quebec, Canada
Boehringer Ingelheim Investigational Site
Regina, Saskatchewan, Canada
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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502.392
Identifier Type: -
Identifier Source: org_study_id