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

November 30, 2023 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

812

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Boehringer Ingelheim Investigational Site
      • Red Deer, Alberta, Canada
        • Boehringer Ingelheim Investigational Site
    • British Columbia
      • Conquitlam, British Columbia, Canada
        • Boehringer Ingelheim Investigational Site
    • New Brunswick
      • Riverview, New Brunswick, Canada
        • Boehringer Ingelheim Investigational Site
      • St. John, New Brunswick, Canada
        • Boehringer Ingelheim Investigational Site
    • Newfoundland and Labrador
      • 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
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • Boehringer Ingelheim Investigational Site
    • Ontario
      • 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
      • Orleans, Ontario, Canada
        • Boehringer Ingelheim Investigational Site
      • Richmond Hill, Ontario, Canada
        • 205-13085 Yonge St
      • St. Catharines, Ontario, Canada
        • 155 Ontario Street
      • 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
    • Prince Edward Island
      • Charlottetown, Prince Edward Island, Canada
        • Boehringer Ingelheim Investigational Site
    • Quebec
      • Granby, Quebec, Canada
        • 4 rue Robinson Nord
      • Longueuil, Quebec, Canada
        • Boehringer Ingelheim Investigational Site
      • Pointe Claire, Quebec, Canada
        • Boehringer Ingelheim Investigational Site
      • St Leonard, Quebec, Canada
        • Boehringer Ingelheim Investigational Site
      • Val D'Or, Quebec, Canada
        • 725 6E Rue
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Boehringer Ingelheim Investigational Site
      • Saskatoon, Saskatchewan, Canada
        • Boehringer Ingelheim Investigational Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States
        • Boehringer Ingelheim Investigational Site
    • Arizona
      • Phoenix, Arizona, United States
        • Boehringer Ingelheim Investigational Site
      • Tucson, Arizona, United States
        • Boehringer Ingelheim Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Harold B. Betton, M.D.
    • California
      • Long Beach, California, United States
        • Attn: Ginger Paselk
      • 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
    • Connecticut
      • Hamden, Connecticut, United States
        • Boehringer Ingelheim Investigational Site
    • Florida
      • 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
    • Georgia
      • Marietta, Georgia, United States
        • Boehringer Ingelheim Investigational Site
    • Idaho
      • Boise, Idaho, United States
        • Boehringer Ingelheim Investigational Site
      • Meridian, Idaho, United States
        • Boehringer Ingelheim Investigational Site
    • Illinois
      • Chicago, Illinois, United States
        • Boehringer Ingelheim Investigational Site
      • Orland Park, Illinois, United States
        • Boehringer Ingelheim Investigational Site
    • Indiana
      • Evansville, Indiana, United States
        • GFI Pharmaceuticals
    • Kansas
      • Newton, Kansas, United States
        • Boehringer Ingelheim Investigational Site
      • Wichita, Kansas, United States
        • Boehringer Ingelheim Investigational Site
    • Louisiana
      • Metairie, Louisiana, United States
        • Boehringer Ingelheim Investigational Site
    • Maine
      • Auburn, Maine, United States
        • Boehringer Ingelheim Investigational Site
    • New Jersey
      • Moorestown, New Jersey, United States
        • Boehringer Ingelheim Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Boehringer Ingelheim Investigational Site
    • New York
      • East Syracuse, New York, United States
        • Boehringer Ingelheim Investigational Site
      • White Plains, New York, United States
        • Boehringer Ingelheim Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
      • Winston-Salem, North Carolina, United States
        • Boehringer Ingelheim Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Boehringer Ingelheim Investigational Site
    • Oregon
      • Portland, Oregon, United States
        • Boehringer Ingelheim Investigational Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States
        • Boehringer Ingelheim Investigational Site
    • South Carolina
      • Anderson, South Carolina, United States
        • Boehringer Ingelheim Investigational Site
      • Spartanburg, South Carolina, United States
        • Spartanburg Medical Research
    • Texas
      • Dallas, Texas, United States
        • Boehringer Ingelheim Investigational Site
      • Lake Jackson, Texas, United States
        • R/D Clinical Research, Inc.
    • Utah
      • Salt Lake City, Utah, United States
        • Boehringer Ingelheim Investigational Site
    • Washington
      • Lacey, Washington, United States
        • Boehringer Ingelheim Investigational Site
      • Lakewood, Washington, United States
        • Boehringer Ingelheim Investigational Site
      • Tacoma, Washington, United States
        • Boehringer Ingelheim Investigational Site
    • West Virginia
      • Charleston, West Virginia, United States
        • Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • 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).
  • 24-hour mean DBP of ≥85 mmHg at Visit 3 as measured by Ambulatory Blood Pressure Monitoring (ABPM).

Exclusion criteria:

  • 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.
  • Further exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Time Frame: Up to week 14
Up to week 14

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to week 14
Up to week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim Study Coordinator, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 9, 2002

Primary Completion (Actual)

November 30, 2003

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimated)

January 11, 2006

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 30, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 502.392

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Telmisartan

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe