HypertensionPhase 4NCT00274638
PROBE Parallel 6-week Treatment Comparing Telmisartan/Hydrochlorothiazide (HCT) (40/12.5 or 80/12.5) With Losartan/HCT (50/12.5) Using Ambulatory Blood Pressure Monitoring (ABPM)
A Phase 4 study testing Telmisartan & Hydrochlorothiazide, Losartan & Hydrochlorothiazide and ABPM in people with Hypertension, run by Boehringer Ingelheim at 69 sites in United States.
Trial summary
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan & Hydrochlorothiazide, Losartan & Hydrochlorothiazide and ABPM
- Type of treatment
- Surgery or procedure
- How many people
- 805 participants
- Where
- 69 sitesUnited States
- Study dates
- Jul 2002to Jul 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 18 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 GCP and local legislation.
- Mild-to-moderate hypertension defined as a mean seated DBP of >= 95 mm Hg and <=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
- Male or Female >= 18 years.
- Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
- 24-hour ABPM mean DBP of >= 85 mm Hg at Visit 3.
Who cannot join
- Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who
- are not surgically sterile, or are
- nursing, or
- are of child-bearing potential and are NOT practicing acceptable methods of birth control, or do not plan to continue practicing an acceptable method throughout the study. Acceptable methods of birth control include IUD, oral, implantable or injectable contraceptives. No exception will be made.
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- Mean seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.
Show all 31Show fewer
- Known or suspected secondary hypertension (i.e. pheochromocytoma).
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (>203 mico mol/l).
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post-renal transplant patients or patients with only one kidney.
- Biliary obstructive disorders.
- Clinically relevant sodium depletion, hypokalaemia or hyperkalaemia.
- Uncorrected volume depletion.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Congestive heart failure (NYHA functional class CHF III-IV).
- Unstable angina within the past 3 months prior to signing the informed consent form.
- Stroke within the past 6 months prior to signing the informed consent form.
- Myocardial infarction or cardiac surgery within the past 3 months prior to signing the inform consent form.
- PTCA (percutaneous transluminal coronary angioplasty) within the past 3 months prior to signing the informed consent form.
- Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant cardiac arrhythmias as determined by the investigator.
- Hypertrophic obstructive cardiomyopathy, aortic stenosis, hemodynamically relevant stenosis of the aortic or mitral valve.
- Patients with insulin-dependent diabetes mellitus whose diabetes has not been stable and controlled for at least the past 3 months as defined by an HbA1C >= 10 Percent.
- Patients who have previously experienced symptoms characteristic of angioedema during treatment with ACE inhibitors or angiotensin II receptor antagonists.
- History of drug or alcohol dependency within 6 months prior to signing the informed consent form.
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol.
- Any investigational therapy within 1 month of signing the informed consent form.
- Known hypersensitivity to any component of the study drugs (placebo, telmisartan, hydrochlorothiazide or losartan).
- Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
- Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with hydrochlorothiazide).
- History of non-compliance with prescribed medication.
- Inability to comply with protocol.
Trial locations and contacts
69 sites in 1 country.
69 sites in 1 country
United States69 sites
New Mexico Clinical Reaearch & Osteoporosis Center, Inc.
Albuquerque, New Mexico
Southern Clinical Research and Management, Inc.
Augusta, Georgia
Comprehensive Clinical Research
Bina, North Carolina
Treasure Valley Cardiology
Boise, Idaho
Boehringer Ingelheim Investigational Site
Carmichael, California
Bennett Cardiac Center
Charlotte, North Carolina
Charlotte Clinical Research
Charlotte, North Carolina
Cedar-Crosse Research Center
Chicago, Illinois
Herron Medical Center, Ltd.
Chicago, Illinois
Boehringer Ingelheim Investigational Site
Cincinnati, Ohio
Radiant Reseach
Cincinnati, Ohio
Bock Clinical Research
Collegeville, Pennsylvania
Radiant Research
Columbus, Ohio
Boehringer Ingelheim Investigational Site
Concord, California
Boehringer Ingelheim Investigational Site
Conyers, Georgia
Boehringer Ingelheim Investigational Site
Coral Gables, Florida
Miami Research Associates
Coral Gables, Florida
Boehringer Ingelheim Investigational Site
Dallas, Texas
Bock Clinical Research
Downingtown, Pennsylvania
Radiant Research
Edina, Minnesota
Protococare Trials, Inc.
Elk Grove Village, Illinois
Attention: Mel E. Lucas, DO
Florissant, Missouri
Sierra Medical Research
Fresno, California
Hampton Roads Medical Specialists
Hampton, Virginia
Bock Clinical Research
Harleysville, Pennsylvania
Patron, Andres, D.O.
Hollywood, Florida
nTouch Research
Houston, Texas
Boehringer Ingelheim Investigational Site
Huntsville, Alabama
Midwest Institute for Clinical Research Inc.
Indianapolis, Indiana
Christopher Chappel, MD
Kissimmee, Florida
University of Tennessee Medical Center
Knoxville, Tennessee
Research Solutions, LLC
Little Rock, Arkansas
Attn: Ginger Paselk
Long Beach, California
Gemini Scientific
Madison, Wisconsin
University of Wisconsin Medical School
Madison, Wisconsin
Boehringer Ingelheim Investigational Site
Melbourne, Florida
Veterans Affairs Medical Center
Memphis, Tennessee
Clinical Research Associates, Inc.
Nashville, Tennessee
Glasgow Family Pract6ice
Newark, Delaware
885 Kempsville Road, Suite 221
Norfolk, Virginia
York Clinical Research
Norfolk, Virginia
Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
nTouch
Oklahoma City, Oklahoma
Boehringer Ingelheim Investigational Site
Orange, California
DeBruin Medical Center
Orangevale, California
Orlando Clinical Research Center
Orlando, Florida
Radiant Research
Overland, Kansas
Ong Medical Center
Oxon Hill, Maryland
Attention: Larry I. Gilderman, D.O.
Pembroke Pines, Florida
N Touch Research
Peoria, Illinois
The Western Pennsylvania Hospital
Pittsburgh, Pennsylvania
Boehringer Ingelheim Investigational Site
Raleigh, North Carolina
nTouch Research Corporation
Raleigh, North Carolina
Boehringer Ingelheim Investigational Site
Richmond, Virginia
Clinical Trials Research
Roseville, California
Dr. R. David Ferrera
Sacramento, California
Cardiology Research
Saint Paul, Minnesota
nTouch Research
St. Petersburg, Florida
Syracuse Preventative Cardiology
Syracuse, New York
Tampa Medical Research Associates
Tampa, Florida
Clinical Research Consultants, Inc.
Trumbull, Connecticut
Hillcrest Medical Center
Tulsa, Oklahoma
Omega Research
Warwick, Rhode Island
Great Lakes Medical Research
Westfield, New York
Westlake Medical Research
Westlake Village, California
Rocky Mountain Pulmonary & Critical Care Medicine, Inc.
Wheat Ridge, Colorado
Cardiology and Internal Medicine- Williamsville NY
Williamsville, New York
Piedmont Research Associates
Winston-Salem, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina
About this study
Official title: A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined With Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets With Losartan Combined With Hydrochlorothiazide (50 mg/12.5 mg) Tablets Using Ambulatory Blood Pressure Monitoring in Patients With Mild-to-Moderate Hypertension
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.
- Conditions
- Hypertension
- Being tested
- Telmisartan & Hydrochlorothiazide, Losartan & Hydrochlorothiazide, ABPM
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan & HydrochlorothiazideDrug
Losartan & HydrochlorothiazideDrug
ABPMProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring)
Measured: after 6 Weeks
Secondary outcomes (6)
Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP)
Measured: after 6 weeks
Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP
Measured: after 6 weeks
Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval
Measured: after 6 weeks
Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval
Measured: after 6 weeks
Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer
Measured: after 6 weeks
Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements
Measured: after 6 weeks
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 startJul 2002
- Primary completionJul 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
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274638
- Sponsor's protocol ID
- 502.387
- Status last verified
- Dec 2013
- First submitted
- 10 Jan 2006
- Last updated
- 9 Dec 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Open-Label, Blinded-Endpoint, Parallel Group 6-week Treatment Study Comparing Telmisartan Combined With Hydrochlorothiazide (40 mg/12.5 mg or 80 mg/12.5 mg) Tablets With Losartan Combined With Hydrochlorothiazide (50 mg/12.5 mg) Tablets Using Ambulatory Blood Pressure Monitoring in Patients With Mild-to-Moderate Hypertension
- ClinicalTrials.gov ID
- NCT00274638
- Acronym / sponsor ID
- 502.387
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2002
- Primary completion
- Jul 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.
To demonstrate that Telmisartan combined with Hydrochlorothiazide (MICARDIS® HCT) is superior to Losartan with Hydrochlorothiazide (Hyzaar®) in lowering blood pressure in mild-moderate hypertensives.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 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 GCP and local legislation.
- Mild-to-moderate hypertension defined as a mean seated DBP of >= 95 mm Hg and <=l to 109 mm Hg, measured by manual cuff sphygmomanometer at Visit 2.
- Male or Female >= 18 years.
- Ability to stop any current antihypertensive therapy without risk to the patient (investigator's discretion).
- 24-hour ABPM mean DBP of >= 85 mm Hg at Visit 3.
Key exclusion criteria (31 listed)
- Pre-menopausal women (last menstruation <= 1 year prior to signing informed consent) who
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- Mean seated SBP >= 180 mm Hg or mean seated DBP >= 110 mm Hg during any visit or the placebo run-in phase.
- Known or suspected secondary hypertension (i.e. pheochromocytoma).
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters: a)SGPT (ALT) or (SGOT) AST less than two times the upper limit of normal range, or b)Serum creatinine greater than 2.3 mg/dL (>203 mico mol/l).
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 & Hydrochlorothiazide | Drug | – |
| Losartan & Hydrochlorothiazide | Drug | – |
| ABPM | Procedure or surgery | – |
Primary outcome
Change from baseline in the last 6-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring)
Time frame: after 6 Weeks
6 secondary outcomes
Change in the last 6-hour ABPM mean (relative to dosing time) for systolic blood pressure (SBP)
Time frame: after 6 weeks
Change in the 24-hour ABPM mean (relative to dosing time) for DBP and SBP
Time frame: after 6 weeks
Change in the ABPM mean DBP and SBP during the morning, daytime, and night-time periods of the 24-hour dosing interval
Time frame: after 6 weeks
Change in systolic and diastolic blood pressure load during the 24-hour dosing interval of the 24-hour dosing interval
Time frame: after 6 weeks
Change in mean seated trough DBP and SBP as measured by manual in-clinic cuff sphygmomanometer
Time frame: after 6 weeks
Responder rates based on both the 24-hour ABPM mean (relative to dose time) blood pressures and the in-clinic trough cuff measurements
Time frame: after 6 weeks
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 9 Dec 2013.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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
69 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Telmisartan & Hydrochlorothiazide, Losartan & Hydrochlorothiazide and ABPM in people with Hypertension, run by Boehringer Ingelheim at 69 sites in United States.
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 31 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 9 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 69 sites in United States. 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-hour mean (relative to dose time) diastolic blood pressure (DBP) as measured by ABPM (Ambulatory Blood Pressure Monitoring) (time frame: after 6 Weeks). 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 9 Dec 2013; AzTrials last refreshed its copy on 6 Nov 2026.