HypertensionPhase 4NCT02172586
Telmisartan With or Without Hydrochlorothiazide (HCTZ) Compared With Losartan With or Without HCTZ in Mild to Moderate Hypertensive Patients
A Phase 4 study testing Telmisartan, Losartan and Hydrochlorothiazide in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment… 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, Losartan and Hydrochlorothiazide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 363 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Jan 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
- Age ≥ 18 years
- Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and < 110 mmHg and systolic blood pressure (SBP) < 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period
- Written informed consent
Who cannot join
- Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation > 1 year prior to start wash-out phase or surgically sterile
- Secondary hypertension
- Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
- Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
- Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial
- Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
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- Angina pectoris or myocardial infarction
- Cardiac surgery within the past 3 months prior to start the wash-out period
- Stroke within the past 6 months prior to start the wash-out period
- Renal insufficiency defined as creatininaemia > 2mg/dl
- Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, post renal transplant, presence of only one functioning kidney
- Liver insufficiency, defined as bilirubinaemia > 2mg/dl and AST (aspartate aminotransferase) or ALT (alanine-aminotransferase) > twice the upper normal range
- Clinically significant metabolic and endocrine disease
- Autoimmune disease
- Previous history of angioedema
- Body mass index > 30kg/m2
- Arm circumference > 32 cm
- Any condition that may be likely to compromise patients participation to the trial (alcohol or drug abuse, disability illness, etc.)
- Concomitant therapy with antihypertensive drugs non permitted by protocol, corticosteroids or drugs known to affect blood pressure
- Concomitant use of lithium or cholestyramine or colestipol resins (potential drug interactions with HCTZ)
- Investigational drug treatment within the past 30 days before the enrolment or concurrent participation to any other trial
- Sensitivity, significant adverse reaction or contraindications to the study drugs (telmisartan, losartan, HCTZ)
- Predictable lack of patient co-operation
About this study
Official title: A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks, and of Telmisartan 80 mg + HCTZ 12.5 mg Once Daily Compared With Losartan 100 mg Once Daily + HCTZ 12.5 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients (Grade 1 and Grade 2 WHO-ISH Guidelines 1999)
Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).
Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM
Safety:
Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters
- Conditions
- Hypertension
- Being tested
- Telmisartan, Losartan, Hydrochlorothiazide
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
LosartanDrug
HydrochlorothiazideDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Not described Receives: Drug: Telmisartan |
| Telmisartan + Hydrochlorothiazide | Experimental | Not described Receives: Drug: Telmisartan; Drug: Hydrochlorothiazide |
| Losartan | Active comparator | Not described Receives: Drug: Losartan |
| Losartan + Hydrochlorothiazide | Active comparator | Not described Receives: Drug: Losartan; Drug: Hydrochlorothiazide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment
Measured: Baseline and week 12
Secondary outcomes (12)
Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study
Measured: Baseline and week 24
Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval
Measured: Baseline, week 12 and 24
Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP)
Measured: Baseline, week 12 and 24
Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP
Measured: Baseline, week 12 and 24
Changes from baseline in SBP/DBP of 24 hours mean ABPM
Measured: Baseline, week 12 and 24
Comparison of SBP/DBP ABPM tracing profile
Measured: Week 12 and 24
Smoothness index in comparison with baseline
Measured: Baseline, week 12 and 24
Number of responders
Measured: Week 12 and 24
Number of controlled responders
Measured: Week 12 and 24
Number of patients who withdraw due to lack of efficacy
Measured: 24 weeks
Number of patients with adverse events
Measured: 24 weeks
Number of patients who withdraw due to adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2000
- Primary completionJan 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
- None (open label)
- Enrolment
- 363 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
- NCT02172586
- Sponsor's protocol ID
- 502.316
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROBE (Prospective, Randomised, Open-label, Blinded Endpoint) Trial to Investigate the Efficacy and Safety of Telmisartan 40-80 mg Once Daily Compared With Losartan 50-100 mg Once Daily Over a Period of 12 Weeks, and of Telmisartan 80 mg + HCTZ 12.5 mg Once Daily Compared With Losartan 100 mg Once Daily + HCTZ 12.5 mg Once Daily Over a Period of Further 12 Weeks in Mild to Moderate Hypertensive Patients (Grade 1 and Grade 2 WHO-ISH Guidelines 1999)
- ClinicalTrials.gov ID
- NCT02172586
- Acronym / sponsor ID
- 502.316
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 363 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2000
- Primary completion
- Jan 2002 (actual)
- First posted
- 24 Jun 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.
Study to assess the efficacy of telmisartan 40-80 mg once daily compared with losartan 50-100 mg once daily in hypertensive patients evaluated by change from baseline in diastolic blood pressure (DBP) during the last 6 hours of the 24-hour dosing interval, at the end of the 12 weeks period of monotherapy treatment (ABPM - ambulatory blood pressure measurement).
Secondary objectives: Changes from baseline in BP at the end of the monotherapy period of treatment and at the end of the study, evaluated by sphygmomanometric blood pressure measurement and ABPM
Safety:
Incidence of adverse events (AE's); withdrawal due to adverse events; laboratory parameters
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartan |
| Telmisartan + Hydrochlorothiazide | Experimental | Drug: Telmisartan, Drug: Hydrochlorothiazide |
| Losartan | Active comparator | Drug: Losartan |
| Losartan + Hydrochlorothiazide | Active comparator | Drug: Losartan, Drug: Hydrochlorothiazide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Mild-to-moderate essential hypertension defined as a mean diastolic blood pressure (DBP) ≥ 95 mmHg and < 110 mmHg and systolic blood pressure (SBP) < 180 mmHg measured by manual cuff sphygmomanometer at the end of the wash-out period
- Written informed consent
Key exclusion criteria (23 listed)
- Nursing, pregnancy or childbearing potential women, post-menopausal women will be enrolled with last menstruation > 1 year prior to start wash-out phase or surgically sterile
- Secondary hypertension
- Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
- Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L and/or clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L or clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
- Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which, in the investigator opinion could compromise patient's participation to the trial
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 | Telmisartan, Telmisartan + Hydrochlorothiazide |
| Losartan | Drug | Losartan, Losartan + Hydrochlorothiazide |
| Hydrochlorothiazide | Drug | Losartan + Hydrochlorothiazide, Telmisartan + Hydrochlorothiazide |
Primary outcome
Change from baseline in diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment
Time frame: Baseline and week 12
12 secondary outcomes
Change from baseline in DBP during the last 6 hours (ABPM) of the 24-hour dosing interval at the end of the study
Time frame: Baseline and week 24
Change from baseline in systolic blood pressure (SBP) during the last 6 hours (ABPM) of the 24-hour dosing interval
Time frame: Baseline, week 12 and 24
Change from baseline in DBP/SBP during the last 2 hours (ABPM) of the 24-hour dosing interval (trough BP)
Time frame: Baseline, week 12 and 24
Changes from baseline in trough cuff (sphygmomanometer) SBP/DBP
Time frame: Baseline, week 12 and 24
Changes from baseline in SBP/DBP of 24 hours mean ABPM
Time frame: Baseline, week 12 and 24
Comparison of SBP/DBP ABPM tracing profile
Time frame: Week 12 and 24
Smoothness index in comparison with baseline
Time frame: Baseline, week 12 and 24
Number of responders
Time frame: Week 12 and 24
Number of controlled responders
Time frame: Week 12 and 24
Number of patients who withdraw due to lack of efficacy
Time frame: 24 weeks
Number of patients with adverse events
Time frame: 24 weeks
Number of patients who withdraw due to adverse events
Time frame: 24 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 24 Jun 2014.
- 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.
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 Telmisartan, Losartan and Hydrochlorothiazide 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 3 inclusion and 23 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 24 Jun 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 diastolic blood pressure (DBP) during the last 6 hours (ABPM - ambulatory blood pressure measurement) of the 24-hour dosing interval at the end of the monotherapy period of treatment (time frame: Baseline and week 12). 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 24 Jun 2014.