HypertensionPhase 4NCT00034840
Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose
A Phase 4 study testing telmisartan, valsartan in people with Hypertension, run by Boehringer Ingelheim at 35 sites in 2 countries.
Trial summary
The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically… 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, valsartan
- How many people
- 490 participants
- Where
- 35 sitesin 2 countries
- Study dates
- Oct 2001to Aug 2002
- 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
- 1. Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP of greater than or equal to 85 mm Hg.
Who cannot join
- Pre-menopausal women (last menstruation = 1 year prior to signing informed consent) who:
- Are not surgically sterile.
- Are nursing.
- 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 exceptions will be made.
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 A.M.
- Mean sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
Show all 31Show fewer
- Known or suspected secondary hypertension (i.e., pheochromocytoma).
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- SGPT (ALT) or SGOT (AST) > 2 times the upper limit of normal range.
- 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.
- Primary aldosteronism.
- Hereditary fructose intolerance.
- Biliary obstructive disorders.
- Congestive heart failure (NYHA functional class CHF III-IV).
- Unstable angina within the past three months prior to signing the informed consent form.
- Stroke within the past six months prior to signing the informed consent form.
- Myocardial infarction or cardiac surgery within the past three months prior to signing the informed consent form.
- PTCA (percutaneous transluminal coronary revascularization) within the past three 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 three months as defined by an HbA1C =10%.
- 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 one month of signing the informed consent form.
- Known hypersensitivity to any component of the formulations.
- Any clinical condition which, in the opinion of the investigator would not allow safe completion of the protocol and safe administration of trial medication.
- Inability to comply with the protocol.
Trial locations and contacts
35 sites in 2 countries.
35 sites in 2 countries
Canada19 sites
Dr. William Booth
Antigonish Nova Scotia, Nova Scotia, B2G 2C2
Dr. Joseph Berlingieri
Burlington, Ontario, L7R 2H3
Heart Health Institute
Calgary, Alberta, T2E 7C5
Dr. William Mahoney
Corunna, Ontario, N0N 1G0
BBM Clinical Research Ltd.
Courtice, Ontario, L1E 3C3
Theradev Clinical Research, Inc.
Granby, Quebec, J2G 8Z9
MSHJ Research Assoc.
Halifax, Nova Scotia, B3K 5R3
Dr. Richard Tytus
Hamilton, Ontario, L8M 1K7
Total Concept Health Care
Kitchener, Ontario, N2C 2N9
Centre for Activity and Aging
London, Ontario, N6G 2M3
Invascor, Longueuil
Longueuil, Quebec, J4N 1E1
Dr. Dennis O'Keefe
Mount Pearl, Newfoundland and Labrador, A1N 2C3
Hotel Dieu de St-Jerome
Saint-Jérôme, Quebec, J7Z 5T3
Centre de Cardiologie
Saint-Lambert, Quebec, J4P 2H4
Centre Hospital Quebec - PAC CHUL Unite de Recherche
Sainte-Foy, Quebec, G1V 4G2
Dr. Martyn Chilvers
Sarnia, Ontario, N7T 4X3
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
Q&T Research
Sherbrooke, Quebec, J1H 4J6
Sunnybrook & Women's College Health Centre
Toronto, Ontario, M4N 3M5
United States16 sites
So. Clinical Research and Management, Inc.
Augusta, Georgia, 30904
University of Maryland/Nephrology Clinical Research Unit
Baltimore, Maryland, 21201
Trinity Hypertension Research Institute/Punzi Medical Center
Carrollton, Texas, 75006
Rush Presbyterian/St. Luke's Medical Center
Chicago, Illinois, 60612
University of Conn. Health Services Center, Hypertension and Vascular Disease
Farmington, Connecticut, 06030
Alan Graff
Fort Lauderdale, Florida, 33308
Greater Ft. Lauderdale Heart Group Research
Fort Lauderdale, Florida, 33308
Harleysville Medical Associates
Harleysville, Pennsylvania, 19438
Memorial Research Medical Clinic
Long Beach, California, 90806
National Research Institute
Los Angeles, California, 90057
UW Health/Physicians Plus Center for Clinical Trials
Madison, Wisconsin, 53715
Oklahoma Cardiovascular and Hypertension Center
Oklahoma City, Oklahoma, 73132
Orange County Research Center
Orange, California, 92868
Orlando Clinical Research Center
Orlando, Florida, 32806
Michael A. Azorr, M.D.
Portland, Oregon, 97232
Washington University
St Louis, Missouri, 63110
About this study
Official title: A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (Telmisartan 80 mg p.o. Once Daily) and Diovan® (Valsartan 160 mg p.o. Once Daily) Using Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Hypertension After Missing One Dose
The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
- Conditions
- Hypertension
- Being tested
- telmisartan, valsartan
- Keywords
- hypertension, telmisartan, valsartan, boehringer
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telmisartan, valsartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose
Measured: after 6 to 8 weeks
Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication
Measured: after 6 to 8 weeks
Secondary outcomes (8)
Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose
Measured: after 6 to 8 weeks
Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment
Measured: after 6 to 8 weeks
Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose
Measured: 8 weeks
Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose
Measured: 8 weeks
Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose
Measured: 8 weeks
Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose
Measured: 8 weeks
Responder rates based on ABPM
Measured: after 6 to 8 weeks
Responder rates based on in-clinic trough cuff blood pressures
Measured: after 6 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2002 (estimated)
- Study startOct 2001
- Primary completionAug 2002
- Study completionAug 2002
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
- Double blind
- Enrolment
- 490 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, Bayer
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00034840
- Sponsor's protocol ID
- 502.327
- Status last verified
- Oct 2013
- First submitted
- 2 May 2002
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-Blind, Forced Titration Trial to Compare the Efficacy of MICARDIS® (Telmisartan 80 mg p.o. Once Daily) and Diovan® (Valsartan 160 mg p.o. Once Daily) Using Ambulatory Blood Pressure Monitoring (ABPM) in Patients With Mild to Moderate Hypertension After Missing One Dose
- ClinicalTrials.gov ID
- NCT00034840
- Acronym / sponsor ID
- 502.327
- Conditions
- Hypertension
- Keywords
- hypertension, telmisartan, valsartan, boehringer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 490 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Collaborators
- GlaxoSmithKline, Bayer
- Study start
- Oct 2001
- Primary completion
- Aug 2002 (actual)
- Study completion
- Aug 2002
- First posted
- 3 May 2002 (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.
The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Mild-to-moderate hypertension defined as a baseline mean seated DBP of greater than or equal to 95 mm Hg and less than or equal to 109 mm Hg and a baseline 24-hour ABPM mean DBP of greater than or equal to 85 mm Hg.
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 sitting SBP =180 mm Hg or mean sitting DBP =110 mm Hg during any visit of the placebo run-in period.
- Known or suspected secondary hypertension (i.e., pheochromocytoma).
- 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, valsartan | Drug | – |
Primary outcome
Change in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose
Time frame: after 6 to 8 weeks
Change in the mean DBP during the last 6 hours of the 24-hour dosing interval, as measured by ABPM after an active dose of study medication
Time frame: after 6 to 8 weeks
8 secondary outcomes
Change in 24-hour ABPM mean systolic blood pressure (SBP) after a missed dose
Time frame: after 6 to 8 weeks
Change in the last 6 hour ABPM mean SBP measured after a dose of active treatment
Time frame: after 6 to 8 weeks
Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after an active dose
Time frame: 8 weeks
Changes in ABPM mean DBP and SBP during other periods of the 24-hour dosing interval after a missed dose
Time frame: 8 weeks
Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after a missed dose
Time frame: 8 weeks
Changes in in-clinic mean seated trough DBP and SBP as measured by manual cuff sphygmomanometer after an active dose
Time frame: 8 weeks
Responder rates based on ABPM
Time frame: after 6 to 8 weeks
Responder rates based on in-clinic trough cuff blood pressures
Time frame: after 6 to 8 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 1 Nov 2013.
- Related InfoLink provided by the sponsor.
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
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
35 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, valsartan in people with Hypertension, run by Boehringer Ingelheim at 35 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 1 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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Canada, 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 in the 24-hour mean diastolic blood pressure (DBP), as measured by ABPM after a missed dose (time frame: after 6 to 8 weeks). The study lists 2 primary outcomes in all. 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 1 Nov 2013.