PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN
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
1 other identifier
interventional
812
2 countries
74
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 9, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2003
CompletedFirst Submitted
Initial submission to the registry
January 10, 2006
CompletedFirst Posted
Study publicly available on registry
January 11, 2006
CompletedDecember 6, 2023
November 1, 2023
1.1 years
January 10, 2006
November 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Up to week 14
Secondary Outcomes (1)
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
Up to week 14
Interventions
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation.
- 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).
- hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM).
You may not qualify if:
- Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention 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
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 10, 2006
First Posted
January 11, 2006
Study Start
October 9, 2002
Primary Completion
November 30, 2003
Last Updated
December 6, 2023
Record last verified: 2023-11