HypertensionPhase 4ESPRITNCT02178306
Efficacy and Safety of Telmisartan in Hypertensive Patients With Mild/Moderate or Severe Renal Impairment or Requiring Hemodialysis
A Phase 4 study testing Telmisartan low dose and Telmisartan high dose in people with Hypertension, run by Boehringer Ingelheim.
Trial summary
To evaluate the safety and efficacy, in particular with regard to renal function of telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to endstage renal impairment after 12 weeks of 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 low dose and Telmisartan high dose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Apr 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
- Mild to moderate hypertension, sitting diastolic BP ≥ 90 mmHg and BP ≤ 109 mmHg at visit 2
- No increase of serum creatinine over 30% within 6 months before the trial
- Stable renal insufficiency with a serum creatinine between 200 and 600 µmol/l or maintenance of hemodialysis
- Stable proteinuria of at least 500 mg/24h
- No change in hemodialysis regimen within the last two months prior to visit 1
- 18 years of age or more
- Ability to provide written informed consent in accordance with good clinical practice and local registration
- Able to stop current antihypertensive therapy (ACE-Inhibitors or angiotensin II receptor subtype 1- Blocker) without risk to the patient
Who cannot join
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in-phase) who:
- are not surgically sterile; and/or
- are nursing
- are of child-bearing potential and are NOT practicing acceptable means of birth control, do NOT plan to continue using this method throughout the study and do NOT agree to submit to periodic pregnancy testing during participation in studies of ≥ 3-months duration. Acceptable methods of birth control include oral, implantable or injectable contraceptives
- Known or suspected renovascular hypertension
- Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in phase
Show all 24Show fewer
- Hepatic dysfunction as defined by the following laboratory parameters:
- serum glutamate pyruvate transaminase (ALT) or serum glutamate oxaloacetate transaminase (AST) > than 2 times the upper limit of normal range
- Bilateral renal artery stenosis; renal artery stenosis in a solitary kidney, patients postrenal transplant or with only one kidney
- Clinically relevant hypo- or hyperkalaemia
- Uncorrected volume depletion
- Uncorrected sodium 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 antagonists
- History of drug or alcohol abuse within 6 months
- Chronic administration of any medications known to affect blood pressure, except medication allowed by the protocol (ß-blocker, alpha-blocker, calcium antagonists, clonidine, minoxidil, and diuretics)
- Any investigational therapy within one month of signing the informed consent form
- Known hypersensitivity to any component of the formulation
- Has no contra-indication to a placebo run-in period (e.g. unstable angina within the past 3 months, stroke within the past 6 months or myocardial infarction or cardiac surgery within the past 3 months)
- Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of telmisartan
- Compliance < 70% during run-in period (defined by pill count)
- History of heart failure, malignancy, or any disorders requiring immunosuppressive therapy
About this study
Official title: An Open-labeled, Placebo run-in, Multicentre Study to Investigate the Efficacy and Safety of Telmisartan (40 and 80 mg QD p.o.) in 3 Strata of Mild to Moderate Hypertensive Patients (Sitting Diastolic Blood Pressure ≥ 90 mmHg and ≤ 109 mmHg From Office Cuff Measurement) With Mild/Moderate or Severe Renal Impairment or Requiring Maintenance Hemodialysis. (ESPRIT Study = Efficacy and Safety in Patients With Renal Impairment Treated With Telmisartan)
To evaluate the safety and efficacy, in particular with regard to renal function of telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to endstage renal impairment after 12 weeks of treatment
- Conditions
- Hypertension
- Being tested
- Telmisartan low dose, Telmisartan high dose, Placebo
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telmisartan low doseDrug
Telmisartan high doseDrug
patients switch to high dose if mean SBP >= 85 mmHg after 4 weeks of treatment
PlaceboDrug
Run-in phase
| Study group | Role | What they receive |
|---|---|---|
| Telmisartan | Experimental | Not described Receives: Drug: Telmisartan low dose; Drug: Telmisartan high dose; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in seated diastolic blood pressure (DBP) at trough
Measured: 12 weeks after start of treatment
Secondary outcomes (8)
Change from baseline in seated systolic blood pressure (SBP) at trough
Measured: 12 weeks after start of treatment
Frequency of response categories of blood pressure
Categories:
- BP normal
- DBP control
- DBP response
- SBP response
- BP high normal
Measured: After 12 weeks of treatment
Changes from baseline in proteinuria
Measured: 12 weeks after start of treatment
Change in electrolyte excretion
Measured: 12 weeks after start of treatment
Area under the telmisartan plasma concentration-time curve
Measured: Day 7 and 12 weeks after start of treatment
Maximum plasma concentration (Cmax) of telmisartan
Measured: Day 7 and 12 weeks after start of treatment
Time to peak (Tmax) plasma concentrations of telmisartan
Measured: Day 7 and 12 weeks after start of treatment
Extent of protein binding of telmisartan
equilibrium dialysis with subsequent determination of protein-bound telmisartan fraction
Measured: Day 7 and 12 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 posted30 Jun 2014 (estimated)
- Study startSep 2000
- Primary completionApr 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 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
- NCT02178306
- Sponsor's protocol ID
- 502.339
- Acronym
- ESPRIT
- Status last verified
- Jun 2014
- First submitted
- 27 Jun 2014
- Last updated
- 30 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-labeled, Placebo run-in, Multicentre Study to Investigate the Efficacy and Safety of Telmisartan (40 and 80 mg QD p.o.) in 3 Strata of Mild to Moderate Hypertensive Patients (Sitting Diastolic Blood Pressure ≥ 90 mmHg and ≤ 109 mmHg From Office Cuff Measurement) With Mild/Moderate or Severe Renal Impairment or Requiring Maintenance Hemodialysis. (ESPRIT Study = Efficacy and Safety in Patients With Renal Impairment Treated With Telmisartan)
- ClinicalTrials.gov ID
- NCT02178306
- Acronym / sponsor ID
- ESPRIT / 502.339
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2000
- Primary completion
- Apr 2002 (actual)
- First posted
- 30 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.
To evaluate the safety and efficacy, in particular with regard to renal function of telmisartan at the doses of 40 mg and 80 mg in hypertensive patients with moderate to endstage renal impairment after 12 weeks of treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Telmisartan | Experimental | Drug: Telmisartan low dose, Drug: Telmisartan high dose, Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Mild to moderate hypertension, sitting diastolic BP ≥ 90 mmHg and BP ≤ 109 mmHg at visit 2
- No increase of serum creatinine over 30% within 6 months before the trial
- Stable renal insufficiency with a serum creatinine between 200 and 600 µmol/l or maintenance of hemodialysis
- Stable proteinuria of at least 500 mg/24h
- No change in hemodialysis regimen within the last two months prior to visit 1
Key exclusion criteria (24 listed)
- Pre-menopausal women (last menstruation ≤ 1 year prior to start of run-in-phase) who:
- Known or suspected renovascular hypertension
- Mean sitting SBP ≥ 180 mmHg or mean sitting DBP ≥110 mmHg during any visit of the placebo run-in phase
- Hepatic dysfunction as defined by the following laboratory parameters:
- serum glutamate pyruvate transaminase (ALT) or serum glutamate oxaloacetate transaminase (AST) > than 2 times the upper limit of normal range
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 low dose | Drug | Telmisartan |
| Telmisartan high dosepatients switch to high dose if mean SBP >= 85 mmHg after 4 weeks of treatment | Drug | Telmisartan |
| PlaceboRun-in phase | Drug | Telmisartan |
Primary outcome
Changes from baseline in seated diastolic blood pressure (DBP) at trough
Time frame: 12 weeks after start of treatment
8 secondary outcomes
Change from baseline in seated systolic blood pressure (SBP) at trough
Time frame: 12 weeks after start of treatment
Frequency of response categories of blood pressure
Time frame: After 12 weeks of treatment
Changes from baseline in proteinuria
Time frame: 12 weeks after start of treatment
Change in electrolyte excretion
Time frame: 12 weeks after start of treatment
Area under the telmisartan plasma concentration-time curve
Time frame: Day 7 and 12 weeks after start of treatment
Maximum plasma concentration (Cmax) of telmisartan
Time frame: Day 7 and 12 weeks after start of treatment
Time to peak (Tmax) plasma concentrations of telmisartan
Time frame: Day 7 and 12 weeks after start of treatment
Extent of protein binding of telmisartan
Time frame: Day 7 and 12 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 30 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 low dose and Telmisartan high dose 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 8 inclusion and 24 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 30 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?
Changes from baseline in seated diastolic blood pressure (DBP) at trough (time frame: 12 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 30 Jun 2014.