HypertensionPhase 4NCT00274599
PROBE Investigation of the Safety & Efficacy of Telmisartan (Micardis®) vs Ramipril (Altace®) Using ABPM in HTN
A Phase 4 study testing Telmisartan and Ramipril in people with Hypertension, run by Boehringer Ingelheim at 74 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan and Ramipril
- How many people
- 812 participants
- Where
- 74 sitesin 2 countries
- Study dates
- 9 Oct 2002to 30 Nov 2003
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 14Show fewer
- 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
Trial locations and contacts
74 sites in 2 countries.
74 sites in 2 countries
United States43 sites
Boehringer Ingelheim Investigational Site
Albuquerque, New Mexico
Boehringer Ingelheim Investigational Site
Anderson, South Carolina
Boehringer Ingelheim Investigational Site
Auburn, Maine
Boehringer Ingelheim Investigational Site
Birmingham, Alabama
Boehringer Ingelheim Investigational Site
Boise, Idaho
Boehringer Ingelheim Investigational Site
Charleston, West Virginia
Boehringer Ingelheim Investigational Site
Charlotte, North Carolina
Boehringer Ingelheim Investigational Site
Chicago, Illinois
Boehringer Ingelheim Investigational Site
Dallas, Texas
Boehringer Ingelheim Investigational Site
Daytona Beach, Florida
Boehringer Ingelheim Investigational Site
East Syracuse, New York
GFI Pharmaceuticals
Evansville, Indiana
Boehringer Ingelheim Investigational Site
Fort Lauderdale, Florida
Boehringer Ingelheim Investigational Site
Hamden, Connecticut
Boehringer Ingelheim Investigational Site
Lacey, Washington
R/D Clinical Research, Inc.
Lake Jackson, Texas
Boehringer Ingelheim Investigational Site
Lakewood, Washington
Boehringer Ingelheim Investigational Site
Levittown, Pennsylvania
Harold B. Betton, M.D.
Little Rock, Arkansas
Attn: Ginger Paselk
Long Beach, California
Boehringer Ingelheim Investigational Site
Los Angeles, California
Boehringer Ingelheim Investigational Site
Marietta, Georgia
Boehringer Ingelheim Investigational Site
Melbourne, Florida
Boehringer Ingelheim Investigational Site
Meridian, Idaho
Boehringer Ingelheim Investigational Site
Metairie, Louisiana
Boehringer Ingelheim Investigational Site
Moorestown, New Jersey
Boehringer Ingelheim Investigational Site
Newton, Kansas
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
Boehringer Ingelheim Investigational Site
Orange, California
Boehringer Ingelheim Investigational Site
Orland Park, Illinois
Boehringer Ingelheim Investigational Site
Phoenix, Arizona
Boehringer Ingelheim Investigational Site
Portland, Oregon
Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
Boehringer Ingelheim Investigational Site
San Diego, California
Boehringer Ingelheim Investigational Site
Santa Ana, California
Boehringer Ingelheim Investigational Site
Santa Rosa, California
Spartanburg Medical Research
Spartanburg, South Carolina
Boehringer Ingelheim Investigational Site
Tacoma, Washington
Boehringer Ingelheim Investigational Site
Tucson, Arizona
Boehringer Ingelheim Investigational Site
Vista, California
Boehringer Ingelheim Investigational Site
White Plains, New York
Boehringer Ingelheim Investigational Site
Wichita, Kansas
Boehringer Ingelheim Investigational Site
Winston-Salem, North Carolina
Canada31 sites
Boehringer Ingelheim Investigational Site
Bay Roberts, Newfoundland and Labrador
Boehringer Ingelheim Investigational Site
Calgary, Alberta
Boehringer Ingelheim Investigational Site
Charlottetown, Prince Edward Island
Boehringer Ingelheim Investigational Site
Conquitlam, British Columbia
Boehringer Ingelheim Investigational Site
Exeter, Ontario
4 rue Robinson Nord
Granby, Quebec
Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
Boehringer Ingelheim Investigational Site
Hastings, Ontario
Boehringer Ingelheim Investigational Site
Kitchener, Ontario
Boehringer Ingelheim Investigational Site
London, Ontario
Boehringer Ingelheim Investigational Site
Longueuil, Quebec
Boehringer Ingelheim Investigational Site
Mount Pearl, Newfoundland and Labrador
Boehringer Ingelheim Investigational Site
North York, Ontario
Boehringer Ingelheim Investigational Site
Oakville, Ontario
Boehringer Ingelheim Investigational Site
Orléans, Ontario
Boehringer Ingelheim Investigational Site
Pointe-Claire, Quebec
Boehringer Ingelheim Investigational Site
Red Deer, Alberta
Boehringer Ingelheim Investigational Site
Regina, Saskatchewan
205-13085 Yonge St
Richmond Hill, Ontario
Boehringer Ingelheim Investigational Site
Riverview, New Brunswick
Boehringer Ingelheim Investigational Site
Saint John, New Brunswick
Boehringer Ingelheim Investigational Site
Saint-Léonard, Quebec
Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan
155 Ontario Street
St. Catharines, Ontario
Boehringer Ingelheim Investigational Site
St. John's, Newfoundland and Labrador
Boehringer Ingelheim Investigational Site
Thunder Bay, Ontario
Boehringer Ingelheim Investigational Site
Toronto, Ontario
725 6E Rue
Val-d'Or, Quebec
Boehringer Ingelheim Investigational Site
Weston, Ontario
Boehringer Ingelheim Investigational Site
Windsor, Ontario
Boehringer Ingelheim Investigational Site
Winnipeg, Ontario
About this study
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
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.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Ramipril
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
RamiprilDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Up to week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2006 (estimated)
- Study start9 Oct 2002
- Primary completion30 Nov 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 812 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274599
- Sponsor's protocol ID
- 502.392
- Status last verified
- Nov 2023
- First submitted
- 10 Jan 2006
- Last updated
- 6 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00274599
- Acronym / sponsor ID
- 502.392
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 812 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2002 (actual)
- Primary completion
- 30 Nov 2003 (actual)
- First posted
- 11 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (14 listed)
- Pre-menopausal women (last menstruation ≤1 year prior to signing informed consent) who:
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telmisartan | Drug | – |
| Ramipril | Drug | – |
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)
Time frame: Up to week 14
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim
74 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan and Ramipril in people with Hypertension, run by Boehringer Ingelheim at 74 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.