HypertensionPhase 4TOPASNCT02200653
A Trial Comparing MICARDIS® (Telmisartan) and COZAAR® / LORZAAR® (Losartan) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (ABPM)
A Phase 4 study testing High dose of MICARDIS®, once daily, Low dose of MICARDIS®, once daily and Low dose of COZAAR® / LORZAAR®, once daily in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- High dose of MICARDIS®, once daily, Low dose of MICARDIS®, once daily and Low dose of COZAAR® / LORZAAR®, once daily
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 387 participants
- Where
- No sites listed yet
- Study dates
- May 2000to Feb 2001
- 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
- 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 3 (baseline cuff BP)
- A 24-mean DBP of ≥ 85 mmHg at Visit 4 as measured by ABPM
- Age 18 years or older
- Ability to stop current antihypertensive therapy without risk to the patient (investigator's discretion)
- Patient's written informed consent in accordance with good clinical practice (GCP) and local legislation
Who cannot join
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
- are not surgically sterile; and/or
- are nursing
- are of child-bearing potential and are NOT practising acceptable means of birth control, do NOT plan to continue using this method throughout the study. Acceptable methods of birth control include oral, implantable or injectable contraceptives
- Known or suspected secondary hypertension
- Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the placebo run-in period
Show all 30Show fewer
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Serum glutamate-pyruvate-transaminase (alanine aminotransferase) or serum glutamate-oxaloacetate-transaminase (aspartate aminotransferase) > than 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; patients post-renal transplant or with only one kidney
- Clinically relevant sodium depletion, hypokalaemia, or hyperkalaemia
- Uncorrected volume depletion
- Primary aldosteronism
- Hereditary fructose intolerance
- Biliary obstructive disorders
- 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
- Chronic administration of any medications known to affect blood pressure, except medications allowed by the protocol
- Any investigational therapy within one month of signing the informed consent form
- Congestive heart failure (NYHA functional class congestive heart failure (CHF) class III-IV)
- Unstable angina within the past six months
- Stroke within the past six months
- Myocardial infarction or cardiac surgery within the past six months
- Percutaneous transluminal coronary angioplasty (PTCA) within the past six months
- 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 hast not been stable and controlled for at least the past three months as defined by an HbA1c ≥ 10%
- Night shift workers who routinely sleep during the daytime and whose work hours include midnight to 4:00 ante meridiem (AM)
- 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
About this study
Official title: A Prospective, Randomised, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (Telmisartan) (40 or 80 mg p.o. Once Daily) and COZAAR® / LORZAAR® (Losartan) (50 or 100 mg p.o. Once Daily) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (TOPAS STUDY = Telmisartan and LOsartan ComParative ABPM Study)
The primary aim of the trial is to compare the influence of MICARDIS® (telmisartan) and COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure
- Conditions
- Hypertension
- Being tested
- High dose of MICARDIS®, once daily, Low dose of MICARDIS®, once daily, Low dose of COZAAR® / LORZAAR®, once daily, High dose of COZAAR® / LORZAAR®, once daily, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High dose of MICARDIS®, once dailyDrug
Also called Telmisartan
Low dose of MICARDIS®, once dailyDrug
Also called Telmisartan
Low dose of COZAAR® / LORZAAR®, once dailyDrug
Also called Losartan
High dose of COZAAR® / LORZAAR®, once dailyDrug
Also called Losartan
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Low dose of MICARDIS® | Experimental | Not described Receives: Drug: Low dose of MICARDIS®, once daily; Drug: Placebo |
| High dose of MICARDIS® | Experimental | Not described Receives: Drug: High dose of MICARDIS®, once daily; Drug: Placebo |
| Low dose of COZAAR® / LORZAAR® | Active comparator | Not described Receives: Drug: Low dose of COZAAR® / LORZAAR®, once daily; Drug: Placebo |
| High dose of COZAAR® / LORZAAR® | Active comparator | Not described Receives: Drug: High dose of COZAAR® / LORZAAR®, once daily; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean diastolic blood pressure
Measured during the last 6 hours of the 24-hour dosing interval using ABPM
Measured: Up to 8 weeks after start of treatment
Secondary outcomes (5)
Change from baseline in mean systolic blood pressure
Measured during the last 6 hours of the 24-hour dosing interval using ABPM
Measured: Up to 8 weeks after start of treatment
Changes from baseline in diastolic and systolic blood pressure
Measured during other times of the 24-hour ABPM profile (e.g. 24-hour mean, morning mean, daytime mean and nighttime mean)
Measured: Up to 8 weeks after start of treatment
Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure
Triplicate measurement in two minute intervals after 5 minutes of rest, in seated position using sphygmomanometer
Measured: Up to 8 weeks after start of treatment
Assessment of responder rates on ABPM
Measured: Baseline, 8 weeks after start of treatment
Assessment of responder rates on trough cuff blood pressure
Measured: Baseline up to 8 weeks after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2014 (estimated)
- Study startMay 2000
- Primary completionFeb 2001
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
- 387 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02200653
- Sponsor's protocol ID
- 502.344
- Acronym
- TOPAS
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 25 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomised, Double-Blind, Double-Dummy, Titration-to-Response Trial Comparing MICARDIS® (Telmisartan) (40 or 80 mg p.o. Once Daily) and COZAAR® / LORZAAR® (Losartan) (50 or 100 mg p.o. Once Daily) in Patients With Mild-to-Moderate Hypertension Using Ambulatory Blood Pressure Monitoring (TOPAS STUDY = Telmisartan and LOsartan ComParative ABPM Study)
- ClinicalTrials.gov ID
- NCT02200653
- Acronym / sponsor ID
- TOPAS / 502.344
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 387 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2000
- Primary completion
- Feb 2001 (actual)
- First posted
- 25 Jul 2014 (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 aim of the trial is to compare the influence of MICARDIS® (telmisartan) and COZAAR® / LORZAAR® (losartan) in lowering ambulatory diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM. Secondary objectives include evaluations of: 1) change from baseline in mean systolic blood pressure (SBP) during the last 6 hours of the 24-hour dosing interval as measured by ABPM, 2) changes from baseline in SBP and DBP during other periods during the 24-hour ABPM profile, 3) changes from baseline in mean seated trough SBP and DBP as measured by manual cuff sphygmomanometer, and 4) responder rates based on both ABPM and trough cuff blood pressure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose of MICARDIS® | Experimental | Drug: Low dose of MICARDIS®, once daily, Drug: Placebo |
| High dose of MICARDIS® | Experimental | Drug: High dose of MICARDIS®, once daily, Drug: Placebo |
| Low dose of COZAAR® / LORZAAR® | Active comparator | Drug: Low dose of COZAAR® / LORZAAR®, once daily, Drug: Placebo |
| High dose of COZAAR® / LORZAAR® | Active comparator | Drug: High dose of COZAAR® / LORZAAR®, once daily, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 3 (baseline cuff BP)
- A 24-mean DBP of ≥ 85 mmHg at Visit 4 as measured by ABPM
- Age 18 years or older
- Ability to stop current antihypertensive therapy without risk to the patient (investigator's discretion)
- Patient's written informed consent in accordance with good clinical practice (GCP) and local legislation
Key exclusion criteria (30 listed)
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in period) who:
- Known or suspected secondary hypertension
- Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥ 110 mmHg during any visit of the placebo run-in period
- Hepatic and/or renal dysfunction as defined by the following laboratory parameters:
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney; patients post-renal transplant or with only one kidney
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 |
|---|---|---|
| High dose of MICARDIS®, once dailyAlso: Telmisartan | Drug | High dose of MICARDIS® |
| Low dose of MICARDIS®, once dailyAlso: Telmisartan | Drug | Low dose of MICARDIS® |
| Low dose of COZAAR® / LORZAAR®, once dailyAlso: Losartan | Drug | Low dose of COZAAR® / LORZAAR® |
| High dose of COZAAR® / LORZAAR®, once dailyAlso: Losartan | Drug | High dose of COZAAR® / LORZAAR® |
| Placebo | Drug | High dose of COZAAR® / LORZAAR®, High dose of MICARDIS®, Low dose of COZAAR® / LORZAAR®, Low dose of MICARDIS® |
Primary outcome
Change from baseline in mean diastolic blood pressure
Time frame: Up to 8 weeks after start of treatment
Measured during the last 6 hours of the 24-hour dosing interval using ABPM
5 secondary outcomes
Change from baseline in mean systolic blood pressure
Time frame: Up to 8 weeks after start of treatment
Changes from baseline in diastolic and systolic blood pressure
Time frame: Up to 8 weeks after start of treatment
Changes from baseline in mean seated trough diastolic blood pressure and systolic blood pressure
Time frame: Up to 8 weeks after start of treatment
Assessment of responder rates on ABPM
Time frame: Baseline, 8 weeks after start of treatment
Assessment of responder rates on trough cuff blood pressure
Time frame: Baseline up to 8 weeks after start of treatment
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 25 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High dose of MICARDIS®, once daily, Low dose of MICARDIS®, once daily and Low dose of COZAAR® / LORZAAR®, once daily in people with Hypertension, run by Boehringer Ingelheim.
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 30 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 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 mean diastolic blood pressure (time frame: Up to 8 weeks after start of treatment). 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 25 Jul 2014.