HypertensionPhase 4NCT02177461
Telmisartan Compared With Enalapril in Elderly Patients With Blood Hypertension
A Phase 4 study testing Telmisartan, Enalapril and Clonidine in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telmisartan, Enalapril and Clonidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- No sites listed yet
- Study dates
- Apr 2000to 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period
- Written informed consent
Who cannot join
- Secondary hypertension
- Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
- Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L, clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
- Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm
- Heart rate < 50 bpm
- Congestive heart failure (CHF) (NYHA (New York Heart Association) functional class CHF III-IV)
Show all 22Show fewer
- 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
- 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 the trial (alcohol or drug abuse, disability illness, etc.)
- Concomitant therapy with antihypertensive drugs non-permitted by protocol, or present use of tricyclic antidepressant, corticosteroids or drugs known to affect blood pressure
- 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, enalapril, clonidine TTS)
- 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 40-80mg Once Daily Compared With 10-20 mg Enalapril Once Daily Over a Period of 24 Weeks in Elderly Patients With Blood Hypertension
Study to assess the efficacy and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.
- Conditions
- Hypertension
- Being tested
- Telmisartan, Enalapril, Clonidine
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelmisartanDrug
EnalaprilDrug
ClonidineDrug
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Not described Receives: Drug: Telmisartan |
| Enalapril | Active comparator | Not described Receives: Drug: Enalapril |
| Telmisartan + clonidine TTS1 | Experimental | Not described Receives: Drug: Telmisartan; Drug: Clonidine |
| Enalapril + clonidine TTS1 | Active comparator | Not described Receives: Drug: Enalapril; Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values)
Measured: Baseline and week 8
Secondary outcomes (7)
Comparison of SBP ABPM tracing profile
Measured: Week 8 and 24
Changes from baseline in trough cuff (sphygmomanometer) SBP
Measured: Baseline, week 8 and 24
Smoothness index in comparison with baseline
Measured: Baseline, week 8 and 24
Number of responders
Measured: Week 8 and 24
Number of controlled responders
Measured: Week 8 and 24
Incidence of 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 posted27 Jun 2014 (estimated)
- Study startApr 2000
- Primary 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
- None (open label)
- Enrolment
- 374 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
- NCT02177461
- Sponsor's protocol ID
- 502.317
- Status last verified
- Jul 2014
- First submitted
- 26 Jun 2014
- Last updated
- 8 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 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 40-80mg Once Daily Compared With 10-20 mg Enalapril Once Daily Over a Period of 24 Weeks in Elderly Patients With Blood Hypertension
- ClinicalTrials.gov ID
- NCT02177461
- Acronym / sponsor ID
- 502.317
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2000
- Primary completion
- Aug 2002 (actual)
- First posted
- 27 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 and tolerability of Telmisartan 40-80 mg once daily compared with enalapril 10-20 mg once daily in elderly patients with arterial hypertension.
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 |
| Enalapril | Active comparator | Drug: Enalapril |
| Telmisartan + clonidine TTS1 | Experimental | Drug: Telmisartan, Drug: Clonidine |
| Enalapril + clonidine TTS1 | Active comparator | Drug: Enalapril, Drug: Clonidine |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- Sitting systolic blood pressure (SBP) ≥ 160 mmHg and any diastolic blood pressure (DBP) (safety maximum of sitting DBP 110 mmHg), measured by manual cuff sphygmomanometer at the end of the wash-out period
- Written informed consent
Key exclusion criteria (22 listed)
- Secondary hypertension
- Malignant hypertension (retinal haemorrhage, exudates or papillary oedema)
- Clinically significant sodium depletion as defined by serum sodium level < 130 mEq/L, clinically significant hyperkaliemia as defined by serum potassium level > 5.5 mEq/L, clinically significant hypokaliemia as defined by serum potassium level < 3.0 mEq/L
- Atrial fibrillation or frequent ventricular ectopic beats or other arrhythmias which could interfere with the cardiac rhythm
- Heart rate < 50 bpm
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 + clonidine TTS1 |
| Enalapril | Drug | Enalapril, Enalapril + clonidine TTS1 |
| Clonidine | Drug | Enalapril + clonidine TTS1, Telmisartan + clonidine TTS1 |
Primary outcome
Change from baseline in 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values)
Time frame: Baseline and week 8
7 secondary outcomes
Comparison of SBP ABPM tracing profile
Time frame: Week 8 and 24
Changes from baseline in trough cuff (sphygmomanometer) SBP
Time frame: Baseline, week 8 and 24
Smoothness index in comparison with baseline
Time frame: Baseline, week 8 and 24
Number of responders
Time frame: Week 8 and 24
Number of controlled responders
Time frame: Week 8 and 24
Incidence of 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 8 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 Telmisartan, Enalapril and Clonidine 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 22 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 8 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 24-hours mean systolic blood pressure (SBP) (ABPM - ambulatory blood pressure measurement, 24 hours mean represents the average of 24 hourly mean values) (time frame: Baseline and week 8). 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 8 Jul 2014.